Skip to main content
MedPathMedPath Home
Clinical Trials/2023-504673-20-00
2023-504673-20-00
Active, not recruiting
Phase 2

A Phase 2b Multicenter, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis

Janssen - Cilag International70 sites in 7 countries102 target enrollmentStarted: November 27, 2023Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Interventions-

Overview

Phase
Phase 2
Status
Active, not recruiting
Enrollment
102
Locations
70
Primary Endpoint
Clinical response at Week 12
OverviewEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To evaluate the efficacy of JNJ-77242113 versus placebo in inducing clinical response

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •18 (or the legal age of consent in the jurisdiction in which the study is taking place) or older.
  • •Documented diagnosis of UC of at least 12 weeks prior to screening, with colitis confirmed at any time in the past by radiography, histology, and/or endoscopy.
  • •Moderately to severely active UC, defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy.
  • •An endoscopy subscore ≥2 as obtained during central review of the screening video endoscopy.
  • •A participant who had extensive UC for ≥8 years, or disease limited to the left side of the colon for ≥10 years, must: a. have had a complete colonoscopy, to assess for the presence of dysplasia within 1 year before the first dose of study intervention. OR b. have a complete colonoscopy with surveillance for dysplasia per local country guidelines at the time of baseline endoscopy performed during the screening period.
  • •A participant ≥45 years of age must either have had a full colonoscopy to assess for the presence of adenomatous polyps within 5 years before the first dose of study intervention or a complete colonoscopy to assess for the presence of adenomatous polyps at the screening visit. The adenomatous polyps must be removed before the first dose of study intervention.

Exclusion Criteria

  • •Patients with current or prior diagnosis of fulminant colitis and/or toxic megacolon.
  • •UC limited to rectum only or to <15 cm of colon.
  • •Presence of a stoma.
  • •Presence or history of fistula.
  • •Has required or will require surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from study intervention treatment within the 8 weeks prior to screening.
  • •History of extensive colonic resection (ie, < 30 cm of colon remaining).
  • •History of colonic mucosal dysplasia. Participants will not be excluded from the study because of pathology finding of “indefinite for dysplasia with reactive atypia.”
  • •Has a stool culture or other examination positive for an enteric pathogen, including Clostridioides difficile (formerly known as Clostridium difficile) toxin, within 4 months before the first dose of study intervention, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen. Note: Treatment and repeat testing can occur in the current screening period.
  • •Has a history of severe, progressive, or uncontrolled renal, genitourinary, hepatic, biliary, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof.

Arms & Interventions

-

Auxiliary

Participants receiving -

Intervention: - (Drug)

Outcomes

Primary Outcomes

Clinical response at Week 12

Clinical response at Week 12

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

CTIS Point of Contact

Scientific

Janssen - Cilag International

Study Sites (70)

Loading locations...

Similar Trials

Completed
Phase 2
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative ColitisColitis, Ulcerative
NCT06049017Janssen Research & Development, LLC252
Active, not recruiting
Phase 3
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
NCT06934226Janssen Research & Development, LLC752
Recruiting
Phase 3
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis.
2024-515706-77-00Janssen Cilag International399
Recruiting
Phase 3
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
2023-507039-39-00Janssen - Cilag International392
Recruiting
Phase 3
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
2023-505121-14-00Janssen - Cilag International320