A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004366-18-AT

Enrollment

Registered

2013-06-12

Start date

2013-07-30

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis in pediatric subjects MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Product Name: Golimumab Product Code: CNTO148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab CAS Number: 476181-74-5 Current Sponsor code: CNTO148 Other descriptive name: H

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Moderate to severe Ulcerative Colitis (UC) defined by a Mayo score (a score used to assess the treatment for UC) of 6 to 12 inclusive, including an endoscopic subscore of 2 or more. • 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 and azathioprine OR • must either have or have had a history of corticosteroid dependency (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC) OR • required more than 3 courses of corticosteroids in the past year • No history of latent or active tuberculosis prior to screening • Positive protective antibody titers to varicella and measles prior to the first administration of study agent • Have severe extensive UC that is likely to require a colectomy (surgical removal of the colon) within 12 weeks of study entry • Have UC limited to the rectum only or to less than 20 cm of the colon • Presence of a stoma • Presence or history of a fistula • Have evidence of Crohn's disease (an inflammatory large intestine disease) • Previous exposure to anti-tumor necrosis factor therapy Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Have severe extensive colitis as evidenced by investigator judgment that the participant is likely to require a colectomy within 12 weeks of baseline; or symptom complex at screening or baseline visits that includes at least 4 of the following: 1) diarrhea with = 6 bowel movements/day with macroscopic blood in stool; 2) focal severe or rebound abdominal tenderness; 3) persistent fever (= 37.5°C); 4) tachycardia (> 90 beats/minute); or 5) anemia (hemoglobin < 8.5 g/dL). • Have UC limited to the rectum only or to < 20 cm of the colon. • Presence of a stoma (a medical opening in the abdomen). • Presence or history of a fistula (an abnormal passageway between two organs of the body). • Have severe, fixed symptomatic stenosis (narrowing) of the large or small intestine.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the PK of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC. To evaluate the safety of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC. ;Secondary Objective: To evaluate the efficacy of golimumab induction (ie, short-term therapy) in pediatric subjects aged 2 through 17 years with moderately to severely active UC.;Primary end point(s): • Serum golimumab concentration at Week 6 • Area under the curve (of serum concentrations) for golimumab from Week 0 to Week 6 (AUC0-6 weeks);Timepoint(s) of evaluation of this end point: See E.5.1	—

Measure

Time frame

Main Objective: To evaluate the PK of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC. To evaluate the safety of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC. ;Secondary Objective: To evaluate the efficacy of golimumab induction (ie, short-term therapy) in pediatric subjects aged 2 through 17 years with moderately to severely active UC.;Primary end point(s): • Serum golimumab concentration at Week 6 • Area under the curve (of serum concentrations) for golimumab from Week 0 to Week 6 (AUC0-6 weeks);Timepoint(s) of evaluation of this end point: See E.5.1

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Secondary

Measure	Time frame
Secondary end point(s): • Number of adverse events up to Week 126 • Physical examination assessments up to Week 126 • Injection-site reactions up to Week 126 • Vital signs assessments up to Week 126 • Clinical laboratory tests up to Week 126 • Early detection of active tuberculosis up to Week 126 • Clinical response at Week 6 • Clinical remission at Week 6 as measured by the Mayo score, which includes stool frequency, rectal bleeding, endoscopy findings, and physician’s global assessment • Pediatric Ulcerative Colitis Activity Index (PUCAI) remission up to Week 110. The PUCAI score includes abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. • Mucosal healing at Week 6;Timepoint(s) of evaluation of this end point: See E.5.2	—

Measure

Time frame

Secondary end point(s): • Number of adverse events up to Week 126 • Physical examination assessments up to Week 126 • Injection-site reactions up to Week 126 • Vital signs assessments up to Week 126 • Clinical laboratory tests up to Week 126 • Early detection of active tuberculosis up to Week 126 • Clinical response at Week 6 • Clinical remission at Week 6 as measured by the Mayo score, which includes stool frequency, rectal bleeding, endoscopy findings, and physician’s global assessment • Pediatric Ulcerative Colitis Activity Index (PUCAI) remission up to Week 110. The PUCAI score includes abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. • Mucosal healing at Week 6;Timepoint(s) of evaluation of this end point: See E.5.2

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Countries

Austria, Belgium, Canada, Denmark, France, Germany, Israel, Netherlands, Poland, United States

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International NV

ClinicalTrialsEU@its.jnj.com+31 71 524 2166

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026