Colitis, Ulcerative Clinical Trial
— QUASAR JrOfficial title:
A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | August 14, 2028 |
Est. primary completion date | May 22, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 17 Years |
Eligibility | Inclusion Criteria: - Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent for screening - A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC. - Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy, and a baseline Mayo rectal bleeding subscore >=1 - Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator - Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids Exclusion Criteria: - Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon - Presence of a stoma - Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline - Have severe colitis or have evidence of Crohn's Disease (CD) |
Country | Name | City | State |
---|---|---|---|
Australia | Perth Children's Hospital | Nedlands | |
Belgium | UZ Gent | Gent | |
Belgium | UZ Brussel | Jette | |
Belgium | UZ Leuven | Leuven | |
China | Capital Institute of Pediatrics | Beijing | |
China | Peking University Third Hospital | Beijing | |
China | Changzhou No 2 Peoples Hospital | Changzhou City | |
China | Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | |
China | The Childrens Hospital Zhejiang University School Of Medicine | Hangzhou | |
China | Ruijin Hospital Shanghai Jiao Tong University | Shanghai | |
China | Shengjing Hospital Of China Medical University | Shenyang | |
China | Henan Children's Hospital, Zhengzhou Children's Hospital | ZhengZhou | |
Denmark | Aarhus Universitetshospital | Aarhus N | |
Denmark | Hvidovre Hospital | Hvidovre | |
France | Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant | Bron cedex | |
France | Hopital Francois Mitterand | Dijon | |
France | CHRU Lille | Lille Cedex | |
France | APHP Hopital Robert Debre | Paris | |
Italy | AOU Meyer | Firenze | |
Italy | AOU Policlinico Umberto I | Roma | |
Italy | Casa Sollievo della Sofferenza | San Giovanni Rotondo | |
Italy | IRCCS Materno Infantile Burlo Garofolo | Trieste | |
Japan | Tokyo Metropolitan Children's Medical Center | Fuchu | |
Japan | Kanazawa University Hospital | Kanazawa | |
Japan | Kobe University Hospital | Kobe | |
Japan | Japanese Red Cross Kumamoto Hospital | Kumamoto | |
Japan | Shinshu University Hospital | Matsumoto | |
Japan | Saga University Hospital | Saga | |
Japan | Tokyo Medical University Hospital | Shinjuku | |
Japan | Osaka Medical and Pharmaceutical University Hospital | Takatsuki | |
Japan | Saiseikai Yokohamashi Tobu Hospital | Yokohama | |
Poland | Korczowski Bartosz Gabinet Lekarski | Rzeszow | |
Poland | Instytut Pomnik Centrum Zdrowia Dziecka | Warszawa | |
Poland | Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus | Warszawa | |
Portugal | Chp - Centro Materno Infantil Do Norte | Porto | |
Portugal | Chsj - Hosp. Sao Joao | Porto | |
Spain | Hosp. Infantil Univ. Nino Jesus | Madrid | |
Spain | Corporacio Sanitari Parc Tauli | Sabadell | |
Spain | Hosp. Univ. I Politecni La Fe | València | |
Turkey | Ankara University Medical Faculty | Ankara | |
Turkey | Gazi University Medical Faculty | Ankara | |
Turkey | Istanbul University Cerrahpasa Medical Faculty | Istanbul | |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | NYU Langone Long Island Clinical Research Associates | Lake Success | New York |
Lead Sponsor | Collaborator |
---|---|
Janssen Research & Development, LLC |
United States, Australia, Belgium, China, Denmark, France, Italy, Japan, Poland, Portugal, Spain, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants with Clinical Remission at Week 56 | Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline. | Week 56 | |
Secondary | Percentage of Participants with Clinical Remission at Week 12 | Percentage of participants with clinical remission at Week 12 as assessed by modified Mayo score will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline. | Week 12 | |
Secondary | Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12 | Percentage of participants with PUCAI remission at Week 12 will be reported. It comprises 6 scales and ranges between 0 and 85 points. The scales are abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission. | Week 12 | |
Secondary | Percentage of Participants with Symptomatic Remission at Week 12 | Percentage of participants with symptomatic remission at Week 12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. | Week 12 | |
Secondary | United States: Percentage of Participants with Endoscopic Improvement at Week 12 | Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. | Week 12 | |
Secondary | European Union: Percentage of Participants with Endoscopic Healing at Week 12 | Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. | Week 12 | |
Secondary | Percentage of Participants with Clinical Response at Week 12 | Percentage of participants with clinical response as assessed by modified Mayo score at Week 12 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. | Week 12 | |
Secondary | Percentage of Participants with Symptomatic Remission at Week 56 | Percentage of participants with symptomatic remission at Week 56 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. | Week 56 | |
Secondary | United States: Percentage of Participants With Endoscopic Improvement at Week 56 | Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. | Week 56 | |
Secondary | European Union: Percentage of Participants With Endoscopic Healing at Week 56 | Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. | Week 56 | |
Secondary | Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56 | Percentage of participants with corticosteroid-free clinical remission at Week 56 will be reported. Corticosteroid free clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline (Week 0), and not receiving corticosteroids for at least 8 weeks prior to Week 56 | Week 56 | |
Secondary | Percentage of Participants with Clinical Response at Week 56 | Percentage of participants with clinical response as assessed by modified Mayo score at Week 56 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by >= 30 percent and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. | Week 56 | |
Secondary | Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56 | Percentage of participants histo-endoscopic mucosal healing per endoscopy subscore and histologic improvement at Week 56 will be reported. Histologic-endoscopic mucosal healing is defined as achieving a combination of histologic improvement and endoscopic improvement (US) or endoscopic healing (EU) (endoscopy subscore of 0 or 1). | Week 56 | |
Secondary | Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12 | Percentage of participants with symptomatic remission at Week 56 among participants who had symptomatic remission at Week 12 will be reported. Symptomatic remission score is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. | Week 56 | |
Secondary | Percentage of Participants Who Achieve Endoscopic Normalization at Week 56 | Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported. | Week 56 | |
Secondary | Percentage of Participants With PUCAI Remission at Week 56 | Percentage of participants with PUCAI remission at Week 56 will be reported. PUCAI comprises of 6 scales and ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission. | Week 56 | |
Secondary | Serum Concentration of Guselkumab During Induction Phase | Serum samples will be analyzed to determine concentrations of guselkumab overtime. | From Week 0 to Week 12 | |
Secondary | Serum Concentration of Guselkumab During Maintenance Phase | Serum samples will be analyzed to determine concentrations of guselkumab over time. | From Week 12 to Week 56 | |
Secondary | Number of Participants with Incidence of Anti-guselkumab Antibodies | Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed. | Up to Week 68 | |
Secondary | Percentage of Participants with Adverse Events (AEs) | Percentage of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. | Up to Week 68 | |
Secondary | Percentage of Participants with Serious Adverse Events (SAEs) | Percentage of participants with SAEs will be reported. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. | Up to Week 68 | |
Secondary | Percentage of Participants with AEs Leading to Discontinuation of Study Intervention | Percentage of participants with AEs leading to discontinuation of study intervention will be reported. | Up to Week 68 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04989907 -
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
|
||
Completed |
NCT03494764 -
Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares
|
Phase 2 | |
Recruiting |
NCT03937609 -
TITRATE (inducTIon for acuTe ulceRATivE Colitis)
|
Phase 4 | |
Completed |
NCT00503243 -
Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
|
Phase 3 | |
Completed |
NCT03606499 -
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
|
||
Completed |
NCT02537210 -
Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis
|
N/A | |
Active, not recruiting |
NCT02316678 -
Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
|
N/A | |
Completed |
NCT00488631 -
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 3 | |
Completed |
NCT00928681 -
A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis
|
Phase 1 | |
Recruiting |
NCT05242484 -
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 2 | |
Completed |
NCT01036022 -
Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis
|
Phase 2 | |
Recruiting |
NCT03841045 -
Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases
|
||
Active, not recruiting |
NCT05528510 -
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 3 | |
Completed |
NCT02825914 -
CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)
|
N/A | |
Recruiting |
NCT06049017 -
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 2 | |
Completed |
NCT04567628 -
Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
|
||
Withdrawn |
NCT05999708 -
A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants
|
Phase 1 | |
Recruiting |
NCT05611671 -
A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
|
Phase 2 | |
Active, not recruiting |
NCT03596645 -
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 3 | |
Completed |
NCT03648541 -
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
|
Phase 2 |