Ulcerative Colitis Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Induction and Maintenance Study to Evaluate the Efficacy and Safety of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.
| Status | Recruiting |
| Enrollment | 1020 |
| Est. completion date | December 17, 2029 |
| Est. primary completion date | November 21, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization - Has moderately to severely active UC - Weight =40 kg - Satisfies at least 1 of the following criteria: - Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments - Protocol specified corticosteroid dependence - Has been intolerant to 1 or more protocol-specified UC treatments - Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable - Adolescent participants =16 and <18 years of age can participate if approved by the country or regulatory/health authority - Participant assigned male sex at birth, if capable of producing sperm, agrees to abstain from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent; or uses prescribed contraception unless azoospermic - A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and Is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy Exclusion Criteria: - Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment. - Has a current diagnosis of fulminant colitis and/or toxic megacolon - Has UC limited to the rectum (i.e, must have evidence of UC extending beyond the rectosigmoid junction, which is ~10 cm from the anal margin) - Has a current or impending need for colostomy or ileostomy - Has had a total proctocolectomy or partial colectomy - Has received fecal microbial transplantation within 4 weeks before randomization - Has been hospitalized for the treatment of UC within 2 weeks before screening - Has prior or current evidence of definite low-grade or high-grade colonic dysplasia including dysplasia identified during the Screening colonoscopy that has not been completely removed - Has any active or serious infections without resolution after adequate treatment - Has had a herpes zoster reactivation or cytomegalovirus that resolved less than 8 weeks before screening - Has a transplanted organ which requires continued immunosuppression - Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years - Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) - Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB) - Has confirmed or suspected COVID-19 infection - Has a history of drug or alcohol abuse within 6 months prior to screening - Has had major surgery within 3 months before screening or has a major surgery (i.e, requiring general anesthesia) planned during the study - Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment - Has received UC-related antibiotics and has not been on stable doses for at least 14 days before randomization or has discontinued these medications within 14 days of randomization - Requires treatment with a therapy that does not adhere to the protocol-specified guidance parameters - Has received protocol-specified prohibited medications - Has had prior exposure to tulisokibart or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Toronto Immune & Digestive Health Institute ( Site 0005) | Toronto | Ontario |
| Chile | Clínica MEDS La Dehesa ( Site 2207) | Lo Barnechea | Region M. De Santiago |
| Chile | CECIM ( Site 2200) | Santiago | Region M. De Santiago |
| Chile | Centro de Estudios Clínicos SAGA-CECSAGA ( Site 2203) | Santiago | Region M. De Santiago |
| Chile | Clínica Universidad de Los Andes ( Site 2202) | Santiago | Region M. De Santiago |
| Chile | FALP-UIDO ( Site 2208) | Santiago | Region M. De Santiago |
| Chile | Pontificia Universidad Catolica de Chile-CICUC ( Site 2205) | Santiago | Region M. De Santiago |
| Chile | Clinical Research Chile SpA ( Site 2201) | Valdivia | Los Rios |
| Dominican Republic | CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 3601) | Santo Domingo | Distrito Nacional |
| Israel | Bnai Zion Medical Center ( Site 1103) | Haifa | |
| Israel | Rambam Health Care Campus ( Site 1101) | Haifa | |
| Israel | Edith Wolfson Medical Center ( Site 1104) | Holon | |
| Israel | Shaare Zedek Medical Center ( Site 1108) | Jerusalem | |
| Israel | Rabin Medical Center ( Site 1107) | Petah Tikva | |
| Israel | Sheba Medical Center ( Site 1100) | Ramat Gan | |
| Japan | Asahikawa City Hospital ( Site 2840) | Asahikawa | Hokkaido |
| Japan | Asahikawa Medical College Hospital ( Site 2815) | Asahikawa | Hokkaido |
| Japan | Ginza Central Clinic ( Site 2824) | Chuo | Tokyo |
| Japan | Sai Gastroenterology/Proctology Clinic ( Site 2814) | Fujiidera | Osaka |
| Japan | Fukuoka University Hospital ( Site 2818) | Fukuoka | |
| Japan | National Hospital Organization Fukuyama Medical Center ( Site 2831) | Fukuyama | Hiroshima |
| Japan | Matsuda Hospital ( Site 2826) | Hamamatsu | Shizuoka |
| Japan | Kansai Medical University Hospital ( Site 2823) | Hirakata | Osaka |
| Japan | Kagoshima IBD Gastroenterology Clinic ( Site 2821) | Kagoshima | |
| Japan | Gokeikai Ofuna Chuo Hospital ( Site 2801) | Kamakura | Kanagawa |
| Japan | Ishikawa Prefectural Central Hospital ( Site 2835) | Kanazawa | Ishikawa |
| Japan | Tsujinaka Hospital - Kashiwanoha ( Site 2802) | Kashiwa | Chiba |
| Japan | Yamanashi Prefectural Central Hospital ( Site 2836) | Kofu | Yamanashi |
| Japan | National Hospital Organization Kyoto Medical Center ( Site 2813) | Kyoto | |
| Japan | Iwate Medical University Uchimaru Medical Center ( Site 2833) | Morioka | Iwate |
| Japan | Hyogo Medical University Hospital ( Site 2830) | Nishinomiya | Hyogo |
| Japan | Ishida Clinic of IBD and Gastroenterology ( Site 2820) | Oita | |
| Japan | Infusion Clinic ( Site 2806) | Osaka | |
| Japan | Saga University Hospital ( Site 2812) | Saga | |
| Japan | Tokitokai Tokito Clinic Coloproctology Center ( Site 2811) | Saitama | |
| Japan | Toho University Sakura Medical Center ( Site 2805) | Sakura | Chiba |
| Japan | Medical Corporation Sapporo IBD Clinic ( Site 2842) | Sapporo | Hokkaido |
| Japan | Sapporo Tokushukai Hospital ( Site 2808) | Sapporo | Hokkaido |
| Japan | Shizuoka Medical Center ( Site 2837) | Shimizu | Shizuoka |
| Japan | The Jikei University Hospital ( Site 2843) | Tokyo | |
| Japan | Tokyo Yamate Medical Center ( Site 2803) | Tokyo | |
| Japan | Toyama Prefectural Central Hospital ( Site 2807) | Toyama | |
| Japan | Mie University Hospital ( Site 2838) | Tsu | Mie |
| Korea, Republic of | Dong-A University Hospital ( Site 3010) | Busan | Pusan-Kwangyokshi |
| Korea, Republic of | Yeungnam Univeristy Medical Center ( Site 3004) | Daegu | Taegu-Kwangyokshi |
| Korea, Republic of | The Catholic University of Korea, Daejeon St. Mary's Hospital ( Site 3011) | Daejeon | Taejon-Kwangyokshi |
| Korea, Republic of | Chung-Ang University Hospital ( Site 3008) | Dongjak-gu | Seoul |
| Korea, Republic of | Inje University Haeundae Paik Hospital ( Site 3009) | Haeundae-gu | Pusan-Kwangyokshi |
| Korea, Republic of | Asan Medical Center ( Site 3007) | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital-Internal Medicine ( Site 3002) | Seoul | |
| Korea, Republic of | Kyung Hee University Hospital ( Site 3013) | Seoul | |
| Korea, Republic of | Samsung Medical Center ( Site 3001) | Seoul | |
| Korea, Republic of | Seoul National University Hospital ( Site 3005) | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System-Department of Internal Medicine ( Site 3000) | Seoul | |
| Korea, Republic of | The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3012) | Seoul | |
| Korea, Republic of | The Catholic University Of Korea St. Vincent's Hospital-Gastroenterology ( Site 3006) | Suwon-si | Kyonggi-do |
| Korea, Republic of | Wonju Severance Christian Hospital-Internal Medicine ( Site 3003) | Wonju | Kang-won-do |
| Netherlands | Radboudumc ( Site 1402) | Nijmegen | Gelderland |
| Switzerland | INTESTO-Gastroenterologische Praxis / Crohn-Colitis Zentrum Bern ( Site 1902) | Bern | Berne |
| Switzerland | Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 1901) | st.Gallen | Sankt Gallen |
| Switzerland | UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 1900) | Zürich | Zurich |
| United States | University of Michigan ( Site 0143) | Ann Arbor | Michigan |
| United States | Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115) | Atlanta | Georgia |
| United States | Baton Rouge General Medical Center - Bluebonnet ( Site 0112) | Baton Rouge | Louisiana |
| United States | Connecticut Clinical Research Institute ( Site 0126) | Bristol | Connecticut |
| United States | Gastroenterology Consultants of Clearwater ( Site 0152) | Clearwater | Florida |
| United States | Clinical Research Institute of Michigan, LLC ( Site 0108) | Clinton Township | Michigan |
| United States | Iowa Digestive Disease Center ( Site 0123) | Clive | Iowa |
| United States | Peak Gastroenterology Associates ( Site 0116) | Colorado Springs | Colorado |
| United States | Atlanta Center for Gastroenterology ( Site 0155) | Decatur | Georgia |
| United States | Digestive Health Specialists ( Site 0135) | Dothan | Alabama |
| United States | IMC-Gulf Coast Gastroenterology ( Site 0157) | Fairhope | Alabama |
| United States | GI Alliance - Garland ( Site 0109) | Garland | Texas |
| United States | GI Alliance - Glenview ( Site 0168) | Glenview | Illinois |
| United States | Carolina Digestive Diseases and Endoscopy Center ( Site 3809) | Greenville | North Carolina |
| United States | GI ALLIANCE - GURNEE ( Site 0107) | Gurnee | Illinois |
| United States | Clinical Trial Network ( Site 3819) | Houston | Texas |
| United States | Nature Coast Clinical Research - Inverness ( Site 3806) | Inverness | Florida |
| United States | Research Solutions of Arizona ( Site 3816) | Litchfield Park | Arizona |
| United States | GI Alliance - Lubbock ( Site 0167) | Lubbock | Texas |
| United States | GI Alliance: Mansfield ( Site 0161) | Mansfield | Texas |
| United States | Circuit Clinical /Middletown Medical PC ( Site 3831) | Middletown | New York |
| United States | Quality Medical Research ( Site 3807) | Nashville | Tennessee |
| United States | New York Gastroenterology Associates ( Site 0159) | New York | New York |
| United States | Clinnova Research - Orange ( Site 3803) | Orange | California |
| United States | Gastroenterology Associates of Orangeburg ( Site 0149) | Orangeburg | South Carolina |
| United States | University Gastroenterology ( Site 0164) | Providence | Rhode Island |
| United States | CARTA - Clinical Associates In Research Therapeutics Of America ( Site 0122) | San Antonio | Texas |
| United States | Southern Star Research Institute ( Site 0106) | San Antonio | Texas |
| United States | GI Alliance - San Marcos ( Site 0130) | San Marcos | Texas |
| United States | GI Alliance - Southlake ( Site 0104) | Southlake | Texas |
| United States | GI Alliance - Sun City ( Site 0103) | Sun City | Arizona |
| United States | Washington Gastroenterology - Tacoma ( Site 0102) | Tacoma | Washington |
| United States | Clinical Research Institute of Michigan, LLC ( Site 0150) | Troy | Michigan |
| United States | Tyler Research Institute ( Site 0105) | Tyler | Texas |
| United States | Texas Digestive Disease Consultants ( Site 0136) | Webster | Texas |
| United States | Velocity Clinical Research, Salt Lake City ( Site 3801) | West Jordan | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC | PPD, Part of Thermo Fisher Scientific |
United States, Canada, Chile, Dominican Republic, Israel, Japan, Korea, Republic of, Netherlands, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12 | The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS. | Week 12 | |
| Primary | Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52 | The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS. | Week 52 | |
| Primary | Study 1: Percentage of Participants With One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE will be reported. | Up to approximately 52 weeks | |
| Primary | Study 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported. | Up to approximately 52 weeks | |
| Primary | Study 2: Percentage of Participants Achieving Clinical Remission Per MMS at Week 12 | The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS. | Week 12 | |
| Primary | Study 2: Percentage of Participants With One or More AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported. | Up to approximately 12 weeks | |
| Primary | Study 2: Percentage of Participants Who Discontinued Study Intervention Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported. | Up to approximately 12 weeks | |
| Secondary | Study 1: Percentage of Participants Achieving Clinical Response Per Partial Modified Mayo Score (pMMS) at Week 2 | The partial Modified Mayo Score (pMMS) is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1. | Week 2 | |
| Secondary | Study 1: Percentage of Participants With Endoscopic Improvement at Week 12 | Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | Week 12 | |
| Secondary | Study 1: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12 | The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1. | Week 12 | |
| Secondary | Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12 | HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). | Week 12 | |
| Secondary | Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12 | pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of =1. | Week 12 | |
| Secondary | Study 1: Percentage of Participants With Endoscopic Remission at Week 12 | ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0. | Week 12 | |
| Secondary | Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 12 | Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more. | Week 12 | |
| Secondary | Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 12 | Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0. | Week 12 | |
| Secondary | Study 1: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12 | The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170. | Week 12 | |
| Secondary | Study 1: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12 | The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented. | Baseline and Week 12 | |
| Secondary | Percentage of Diagnostic Assay Positive (Dx+) Participants Achieving Clinical Remission Per MMS at Week 12 | Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS. | Week 12 | |
| Secondary | Percentage of Dx+ Participants With Endoscopic Improvement at Week 12 | Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | Week 12 | |
| Secondary | Study 1: Percentage of Participants Achieving Histologic-Endoscopic Remission (HER) at Week 12 | HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). | Week 12 | |
| Secondary | Study 1: Percentage of Participants with Endoscopic Improvement at Week 52 | Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | Week 52 | |
| Secondary | Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission Per MMS at Week 52 | The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Corticosteroid-free clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, and no corticosteroid use for =90 days before Week 52. | Week 52 | |
| Secondary | Study 1: Percentage of Participants Achieving HEMI at Week 52 | HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). | Week 52 | |
| Secondary | Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 52 | pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of =1. | Week 52 | |
| Secondary | Study 1: Percentage of Participants Achieving Sustained Clinical Remission Per MMS at Both Week 12 and Week 52 | The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, at both Week 12 and Week 52. | Week 12 and Week 52 | |
| Secondary | Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 52 | Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more. | Week 52 | |
| Secondary | Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 52 | Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0. | Week 52 | |
| Secondary | Study 1: Percentage of Participants With Endoscopic Remission at Week 52 | ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0. | Week 52 | |
| Secondary | Study 1: Percentage of Participants with Sustained Clinical Response Per MMS at Both Week 12 and Week 52 | The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1, at both Week 12 and Week 52. | Week 12, and Week 52 | |
| Secondary | Study 1: Percentage of Participants with Sustained Endoscopic Improvement at Both Week 12 and Week 52 | Sustained endoscopic improvement is defined as an ES of 0 or 1 at both Week 12 and Week 52. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | Week 12 and Week 52 | |
| Secondary | Study 1: Percentage of Participants Achieving HER at Week 52 | HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). | Week 52 | |
| Secondary | Study 1: Percentage of Participants Achieving IBDQ Remission at Week 52 | The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170. | Week 52 | |
| Secondary | Study 1: Change from Baseline in FACIT-Fatigue Score at Week 52 | The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented. | Baseline and Week 52 | |
| Secondary | Study 1: Percentage of Dx+ Participants Achieving Clinical Remission Per MMS at Week 52 | Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS. | Week 52 | |
| Secondary | Study 1: Percentage of Dx+ Participants With Endoscopic Improvement at Week 52 | Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | Week 52 | |
| Secondary | Study 2: Percentage of Participants with Clinical Response Per pMMS at Week 2 | pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1. | Week 2 | |
| Secondary | Study 2: Percentage of Participants With Endoscopic Improvement at Week 12 | Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity. | Week 12 | |
| Secondary | Study 2: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12 | The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1. | Week 12 | |
| Secondary | Study 2: Percentage of Participants Achieving HEMI at Week 12 | HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). | Week 12 | |
| Secondary | Study 2: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12 | pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of =1. | Week 12 | |
| Secondary | Study 2: Percentage of Participants With Endoscopic Remission at Week 12 | ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0. | Week 12 | |
| Secondary | Study 2: Percentage of Participants Reporting No Bowel Urgency at Week 12 | Bowel urgency is measured using a numeric rating scale (NRS), which rates bowel urgency on a 0-11 scale of increasing severity. | Week 12 | |
| Secondary | Study 2: Percentage of Participants Reporting No Abdominal Pain at Week 12 | Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0. | Week 12 | |
| Secondary | Study 2: Percentage of Participants Achieving IBDQ Remission at Week 12 | The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170. | Week 12 | |
| Secondary | Study 2: Change from Baseline in FACIT-Fatigue Score at Week 12 | The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented. | Baseline and Week 12 | |
| Secondary | Study 2: Percentage of Participants Achieving HER at Week 12 | HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. | Week 12 |
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