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A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC)

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ClinicalTrials.gov Identifier: NCT06049017
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE September 15, 2023
First Posted Date  ICMJE September 21, 2023
Last Update Posted Date March 28, 2024
Actual Study Start Date  ICMJE October 9, 2023
Estimated Primary Completion Date May 27, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2023)		 Percentage of Participants with Clinical Response at Week 12 [ Time Frame: Week 12 ]
Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2023)
  • Percentage of Participants with Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
  • Percentage of Participants with Symptomatic Remission at Week 12 [ Time Frame: Week 12 ]
    Symptomatic remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, and a rectal bleeding subscore of 0.
  • Percentage of Participants with Endoscopic Improvement at Week 12 [ Time Frame: Week 12 ]
    Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
  • Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12 [ Time Frame: Week 12 ]
    Histologic-endoscopic mucosal improvement is defined as a combination of histologic remission and endoscopic improvement. Histologic remission and endoscopic improvement are based on the histologic grading and the Mayo endoscopy subscore.
  • Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs) [ Time Frame: Up to Week 76 ]
    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. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • Drug: JNJ-77242113
    JNJ-77242113 tablet will be administered orally.
  • Drug: Placebo
    Placebo tablet will be administered orally.
Study Arms  ICMJE
  • Experimental: Group 1: JNJ-77242113 Dose-1
    Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.
    Intervention: Drug: JNJ-77242113
  • Experimental: Group 2: JNJ-77242113 Dose-2
    Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.
    Intervention: Drug: JNJ-77242113
  • Experimental: Group 3: JNJ-77242113 Dose-3
    Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.
    Intervention: Drug: JNJ-77242113
  • Experimental: Group 4: Placebo
    Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76.
    Interventions:
    • Drug: JNJ-77242113
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2023)		 240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 6, 2026
Estimated Primary Completion Date May 27, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent form 18 years of age or older
  • Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to screening
  • Moderately to severely active UC as per the modified Mayo score
  • Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

Exclusion Criteria:

  • Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
  • UC limited to rectum only or to less than (<) 15 centimeters (cm) of colon
  • Presence of a stoma
  • Presence or history of fistula
  • History of extensive colonic resection (example, <30 cm of colon remaining)
  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   China,   Czechia,   France,   Germany,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Poland,   Romania,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06049017
Other Study ID Numbers  ICMJE 77242113UCO2001
77242113UCO2001 ( Other Identifier: Janssen Research & Development, LLC )
2023-504673-20-00 ( Registry Identifier: EUCT number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency
Current Responsible Party Janssen Research & Development, LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Janssen Research & Development, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP