A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 3RecruitingNCT07577856

Janssen Research & Development, LLC644 enrolled

Overview

The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

644

Conditions

Colitis, Ulcerative

Interventions

JNJ-78934804DRUG

JNJ-78934804 will be administered subcutaneously.

GuselkumabDRUG

Guselkumab will be administered subcutaneously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC. * Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy * An endoscopy subscore \>=2 as obtained during central review of the screening video endoscopy * Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies Exclusion criteria: * Isolated proctitis (UC limited to the rectum only or to less than \[\<\] 20 centimeter \[cm\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD * Has a history of or ongoing chronic or recurrent infectious disease * Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab * Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention

Locations (170)

Outcomes

Primary Outcomes

Percentage of Participants in Clinical Remission at Week 48

Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1.

Time frame: At Week 48

Secondary Outcomes

Percentage of Participants with Endoscopic Improvement at Week 48

Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.

Time frame: At Week 48

Percentage of Participants with Corticosteroid-free (90 day) Clinical Remission at Week 48

Corticosteroid-free (90 day) clinical remission is defined as clinical remission at the visit and not receiving corticosteroids for 90 days prior to the visit.

Time frame: At Week 48

Percentage of Participants Achieving a Combination of Histologic Remission and Endoscopic Improvement at Week 48

Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Histologic remission is defined as an absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system.

Time frame: At Week 48

Percentage of Participants with Fatigue Response (PROMIS Fatigue Short Form 7a) at Week 48

Fatigue response is defined as a greater than or equal to (\>=) 7- point reduction in the patient-reported outcomes measurement information system (PROMIS) fatigue short form 7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise).

Time frame: At Week 48

Central Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

Data from ClinicalTrials.gov

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Clinnova Research

Anaheim, California, United States

RECRUITING

Gastro SB Clinic

Chula Vista, California, United States

RECRUITING

United Medical Doctors

Los Alamitos, California, United States

RECRUITING

Medical Associates Research Group, Inc.

San Diego, California, United States

RECRUITING

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

RECRUITING

Florida Research Center Inc.

Lakewood Rch, Florida, United States

RECRUITING

Sanchez Clinical Research, Inc

Miami, Florida, United States

RECRUITING

GCP Clinical Research

Tampa, Florida, United States

RECRUITING

Atlanta Gastroenterology Specialists

Suwanee, Georgia, United States

RECRUITING

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky, United States

RECRUITING

...and 160 more locations

Percentage of Participants with Sustained Mayo SF Less Than or Equal to (<=) 1 and RB=0

Percentage of participants with a SF subscore of 0 or 1 and RB subscore of 0 at three assessment time points of Week 12, Week 24, and Week 48 will be reported.

Time frame: At Weeks 12, 24, and 48

Percentage of Participants in Abdominal Pain Remission at Week 48

Percentage of participants in abdominal pain remission at week 48 will be reported.

Time frame: At Week 48

Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48

IBDQ response is defined as improvement from baseline in the total IBDQ score of \>= 16 points. The IBDQ is a 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific health-related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability).

Time frame: At Week 48

Percentage of Participants with PROMIS-29 Mental Component Summary (MCS) Response at Week 48

PROMIS 29 MCS response is defined as a \>= 7-point improvement from baseline in PROMIS 29 MCS response at Week 48. The PROMIS-29 is a collection of short forms containing 4 items for each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities). The PROMIS-29 MCS will be assessed, which is primarily informed by domains of emotional distress (depression/anxiety) and fatigue as well as sleep disturbance where higher MCS scores reflect better mental health.

Time frame: At Week 48

Percentage of Participants in Clinical Remission at Week 12

Clinical remission is defined as an SF subscore of 0 or 1, RB subscore of 0, and an endoscopy subscore of 0 or 1.

Time frame: At Week 12

Percentage of Participants with Endoscopic Improvement at Week 12

Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.

Time frame: At Week 12

Percentage of Participants with Mayo SF/RB Response at Week 2

Mayo SF/RB response is defined as a decrease from baseline in the sum of the SF and the RB subscores by \>=30 percent (%) and \>= 1 point, with either a \>= 1 point decrease from baseline in the RB subscore or an RB subscore of 0 or 1.

Time frame: At Week 2

Percentage of Participants with Adverse Events (AE) and Serious AEs (SAEs)

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. An 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, and is medically important.

Time frame: Up to approximately 3 years