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

Purpose

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).

Condition

  • Colitis, Ulcerative

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
JNJ-78934804 		Participants will receive JNJ-78934804 induction dose at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind (DB) treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.
  • Drug: JNJ-78934804
    JNJ-78934804 will be administered subcutaneously.
    Other names:
    • JNJ-4804
Active Comparator
Guselkumab 		Participants with moderately to severely active UC will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete DB treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.
  • Drug: JNJ-78934804
    JNJ-78934804 will be administered subcutaneously.
    Other names:
    • JNJ-4804
  • Drug: Guselkumab
    Guselkumab will be administered subcutaneously.
    Other names:
    • TREMFYA

Recruiting Locations

Clinnova Research
Anaheim, California 92805

Gastro SB Clinic
Chula Vista, California 91910

United Medical Doctors
Los Alamitos, California 90720

Medical Associates Research Group, Inc.
San Diego, California 92123

Peak Gastroenterology Associates
Colorado Springs, Colorado 80907

Florida Research Center Inc.
Lakewood Rch, Florida 34211

Sanchez Clinical Research, Inc
Miami, Florida 33157-6575

GCP Clinical Research
Tampa, Florida 33609

Atlanta Gastroenterology Specialists
Suwanee, Georgia 30024

Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky 41017

Gastroenterology Clinic of Acadiana
Lafayette, Louisiana 70503

Michigan Center of Medical Research
Farmington Hills, Michigan 48334

New York Gastroenterology Associates
New York, New York 10075

Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060

Digestive Disease Specialists Inc
Oklahoma City, Oklahoma 73114

The Oregon Clinic
Portland, Oregon 97220

Gastro One
Cordova, Tennessee 38018

Southern Star Research Institute, LLC
San Antonio, Texas 78229

Tyler Research Institute, LLC
Tyler, Texas 75701

GI Alliance Tacoma
Tacoma, Washington 98405

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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