A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
DUET ENCORE-UC
A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
2 other identifiers
interventional
644
11 countries
63
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2026
Typical duration for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2026
CompletedFirst Posted
Study publicly available on registry
May 11, 2026
CompletedStudy Start
First participant enrolled
May 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2030
July 31, 2026
July 1, 2026
2.2 years
May 5, 2026
July 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
At Week 48
Secondary Outcomes (12)
Percentage of Participants with Endoscopic Improvement at Week 48
At Week 48
Percentage of Participants with Corticosteroid-free (90 day) Clinical Remission at Week 48
At Week 48
Percentage of Participants Achieving a Combination of Histologic Remission and Endoscopic Improvement at Week 48
At Week 48
Percentage of Participants with Fatigue Response (PROMIS Fatigue Short Form 7a) at Week 48
At Week 48
Percentage of Participants with Sustained Mayo SF Less Than or Equal to (<=) 1 and RB=0
At Weeks 12, 24, and 48
- +7 more secondary outcomes
Study Arms (2)
JNJ-78934804
EXPERIMENTALParticipants 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.
Guselkumab
ACTIVE COMPARATORParticipants 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.
Interventions
JNJ-78934804 will be administered subcutaneously.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Clinnova Research
Anaheim, California, 92805, United States
Gastro SB Clinic
Chula Vista, California, 91910, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Sanchez Clinical Research, Inc
Miami, Florida, 33157-6575, United States
GCP Clinical Research
Tampa, Florida, 33609, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, 41017, United States
Michigan Center of Medical Research
Farmington Hills, Michigan, 48334, United States
New York Gastroenterology Associates
New York, New York, 10075, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73114, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
Banksia Trials SA
Adelaide, 5000, Australia
SA Gastrointestinal Services
Kurralta Park, 5037, Australia
Mater Misericordiae Hospital
South Brisbane, 4101, Australia
Pesquisare Saude
Santo André, 09080-110, Brazil
BR Trials
São Paulo, 01236 030, Brazil
South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta, Code: T6K 4B2, Canada
GI Research Institute (G.I.R.I.)
Vancouver, British Columbia, V6Z 2K5, Canada
Viable Clinical Research
Kentville, Nova Scotia, B4N 0A3, Canada
Barrie GI Associates
Barrie, Ontario, L4M 7G1, Canada
Charlton Digestive Disease Centre
Hamilton, Ontario, L8N1Y2, Canada
London Digestive Disease Institute
London, Ontario, N6K 1M6, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, M6A 3B4, Canada
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, H2X 0C1, Canada
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510080, China
Assuta Medical center
Ashdod, 7747629, Israel
Rambam Medical Center
Haifa, 3109601, Israel
Bnai Zion Medical Center
Haifa, 60910, Israel
Wolfson Medical Center
Holon, 5822012, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Galilee Medical Center
Nahariya, 2210001, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Matsuda Hospital
Hamamatsu, 432-8061, Japan
National Hospital Organization Mito Medical Center
Higashi-Ibaraki, 311-3193, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, 892-0843, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, 277-0871, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Takano Hospital
Kumamoto, 862-0971, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, 108-8642, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
Oita Red Cross Hospital
Ōita, 870-0033, Japan
Saga University Hospital
Saga, 849-8501, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, 060-0033, Japan
National Hospital Organization Shizuoka Medical Center
Shimizu, 411-8611, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, 130 8575, Japan
Yamanashi Prefectural Central Hospital
Yamanashi, 400-8506, Japan
Hospital Ampang
Ampang, 68000, Malaysia
Sultan Idris Shah Hospital
Kajang, 43000, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
Hospital Sultanah Nur Zahirah
Kuala Terengganu, 20400, Malaysia
Samsung Medical Center
Gangnam Gu, 06351, South Korea
Linkou Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
Antalya Training And Research Hospital
Antalya, 07100, Turkey (Türkiye)
Sanko Universitesi Hastanesi
Gaziantep, 27090, Turkey (Türkiye)
Bezmialem University Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Izmir Sehir Hastanesi
Izmir, 35540, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41001, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33343, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2026
First Posted
May 11, 2026
Study Start
May 23, 2026
Primary Completion (Estimated)
August 11, 2028
Study Completion (Estimated)
October 30, 2030
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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.