A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

— PURSUIT 2  

Official title:

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03596645
• Other study ID #: CR108499
• Secondary ID: 2017-004496-31CN
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 29, 2018
• Est. completion date: August 31, 2027

Study information

• Verified date: April 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: August 31, 2027
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or azathioprine OR must either have or have had a history of corticosteroid dependency (that is an inability to successfully taper corticosteroids without a return of the symptoms of ulcerative colitis [UC]) OR required more than 3 courses of corticosteroids in the past year
• Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12 [endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist], inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal to (>=2)
• If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at Week 0. Participants who receive parenteral nutrition are not permitted to enroll in the trial
• No history of latent or active tuberculosis prior to screening
• Must be up to date with all immunizations (that is, measles, mumps, rubella, and varicella) in agreement with current local immunization guidelines for immunosuppressed participants before Week 0

Exclusion Criteria:

• History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric (including suicidality), or metabolic disturbances
• History of malignancy or macrophage activation syndrome or hemophagocytic lymphohistiocytosis
• Have UC limited to the rectum only or to <20 percent (%) of the colon
• Presence of a stoma
• Presence or history of a fistula
• Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor (TNF-alpha) therapy per local prescribing information

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Golimumab
Participants receive subcutaneous (SC) golimumab through Week 50, where doses will be based on body surface area. After the Week 54 evaluations, at the discretion of investigator, participants benefiting from continued SC golimumab will continue to receive SC golimumab in the extension until end of study.
• Infliximab
Participants will receive infliximab intravenous (IV) through Week 46. Doses will be based on body weight. After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their physician.

Locations

Country	Name	City	State
Belgium	Universitair Kinderziekenhuis Koningin Fabiola	Brussel
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	UZ Brussel	Jette
Brazil	MK Blumenau Pesquisa Clínica	Blumenau
Brazil	Hospital Pequeno Principe	Curitiba
Brazil	Irmandade Santa Casa de Misericordia de Porto Alegre	Porto Alegre
Brazil	BR Trials	Sao Paulo
France	Hopital Pellegrin CHU Bordeaux	Bordeaux
France	Hôpital Necker	Paris
Israel	Rambam Medical Center	Haifa
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Schneider Children's Medical Center	Petah Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Assaf Harofeh Medical Center	Rishon-Le-Zion
Israel	Sourasky Medical Center	Tel-Aviv
Italy	Azienda USL di Bologna - Ospedale Maggiore	Bologna
Italy	AOU Meyer	Firenze
Italy	AOU Policlinico G.Martino	Messina
Italy	AOU Policlinico Umberto I	Roma
Italy	IRCCS Ospedale Pediatrico Bambino Gesu	Roma
Italy	Casa Sollievo della Sofferenza, IRCCS	San Giovanni Rotondo
Italy	IRCCS Materno Infantile Burlo Garofolo	Trieste
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Netherlands	Emma Children's Hospital Academic Medical Center	Amsterdam
Netherlands	Isala Kliniek	Zwolle
Poland	Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza	Bydgoszcz
Poland	Szpital im. M. Kopernika	Gdansk
Poland	Uniwersytecki Szpital Dzieciecy w Krakowie	Krakow
Poland	Wojewodzki Specjalistyczny Szpital Dzieciecy im. Prof. Stanislawa Popowskiego	Olsztyn
Poland	Korczowski Bartosz Gabinet Lekarski	Rzeszow
Poland	Centrum Zdrowia Matki, Dziecka i Mlodziezy	Warszawa
Poland	Szpital Pomnik Centrum Zdrowia Dziecka	Warszawa
Spain	Hosp. Univ. de Cruces	Barakaldo
Spain	Hosp. Sant Joan de Deu	Barcelona
Spain	Hosp. Gral. Univ. Gregorio Maranon	Madrid
Spain	Hosp. Infantil Univ. Nino Jesus	Madrid
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Regional Univ. de Malaga	Málaga
Spain	Hosp. Virgen Del Rocio	Sevilla
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital- Linkou	Taoyuan City
United States	Children's Center for Digestive Health Care	Atlanta	Georgia
United States	Children's Hospital Colorado and University of Colorado	Aurora	Colorado
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	Cook Childrens Medical Center	Fort Worth	Texas
United States	DHAT Research Institute	Garland	Texas
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	GI For Kids	Knoxville	Tennessee
United States	Rocky Mountain Pediatric Gastroenterology	Lone Tree	Colorado
United States	Columbia University Medical Center	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California San Francisco	San Francisco	California
United States	Nemours DuPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  France,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Remission at Week 6 as Assessed by the Mayo Score	Clinical remission is defined as a Mayo score less than or equal to (<=) 2 points, with no individual sub score greater than (>) 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe activity. The total score is calculated as the sum of the 4 sub scores and values range from 0 to 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.	At Week 6
Secondary	Symptomatic Remission at Week 54	Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.	At Week 54
Secondary	Clinical Remission at Week 54 as Assessed by the Mayo score	Clinical remission is defined as a Mayo score <=2 points, with no individual subscore >1 (based on Mayo endoscopy subscore assigned by the local endoscopist). The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe activity. The total score is calculated as the sum of the 4 sub scores and values range from 0 to 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.	At Week 54
Secondary	Clinical Remission at Week 54 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score	Clinical remission is defined as a PUCAI score less than (<)10. The PUCAI is a noninvasive measure of UC disease activity. It comprises 6 scales and total score 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 total score is calculated as the sum of the 6 subscores. Higher scores indicate a more severe disease.	At Week 54
Secondary	Clinical Remission at Week 6 as Assessed by the PUCAI Score	Clinical remission is defined as a PUCAI score <10. The PUCAI is a noninvasive measure of ulcerative colitis (UC) disease activity. It comprises 6 scales and total score 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 total score is calculated as the sum of the 6 subscores. Higher scores indicate a more severe disease.	At Week 6
Secondary	Clinical Response at Week 6 as Assessed by the Mayo Score	Clinical response is defined as a decrease from baseline in the Mayo score of greater than or equal to (>=)30 percent (%) and >=3 points, with either a decrease from baseline in the rectal bleeding subscore of >=1 or a rectal bleeding subscore of 0 or 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe activity. The total score is calculated as the sum of the 4 sub scores and values range from 0 to 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.	At Week 6
Secondary	Endoscopic Healing at Week 6	Endoscopic healing is defined as an endoscopy subscore of the Mayo score of 0 (normal or inactive disease) or 1 (mild disease).	At Week 6
Secondary	Endoscopic Healing at Week 54	Endoscopic healing is defined as an endoscopy subscore of the Mayo score of 0 (normal or active disease) or 1 (mild disease).	At Week 54
Secondary	Clinical Remission at Week 54 Assessed by the Mayo score for Participants who are in Clinical Remission at Week 6	Clinical remission is defined as a Mayo score <=2 points, with no individual subscore >1 (based on Mayo endoscopy subscore assigned by the local endoscopist). The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe activity. The total score is calculated as the sum of the 4 sub scores and values range from 0 to 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.	At Week 54
Secondary	Number of Participants who were not Receiving Corticosteroids for At least 12 Weeks Prior to Week 54 and in Clinical Remission at Week 54	Number of participants who were not receiving corticosteroids for at least 12 Weeks prior to Week 54 and in clinical remission at Week 54 will be reported.	At Week 54