A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
NCT07577843 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460
Last updated 2026-05-11
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 Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).
Conditions
- Crohn Disease
Interventions
- DRUG
-
JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
- DRUG
-
Guselkumab
Guselkumab will be administered subcutaneously.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-29
- Primary Completion
- 2028-06-12
- Completion
- 2030-07-12
- FDA Drug
- Yes
More Related Trials
-
An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
NCT07528040 ·Status: NOT_YET_RECRUITING
-
A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
NCT07487480 ·Status: RECRUITING
-
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
NCT06430801 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
NCT04397263 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)
NCT07242248 ·Status: RECRUITING
-
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
NCT05347095 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
NCT03466411 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
NCT04102111 ·Status: TERMINATED ·Phase: PHASE2
-
Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)
NCT01218360 ·Status: COMPLETED
-
A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
NCT05784129 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
NCT03782376 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
NCT05923073 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
NCT07310095 ·Status: RECRUITING ·Phase: PHASE4
-
A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
NCT01369329 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab
NCT07532213 ·Status: NOT_YET_RECRUITING
-
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
NCT05242484 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
IUS Predicts Guselkumab Efficacy in Patients With Moderate to Severe Crohn's Disease:a Prospective Study
NCT07034664 ·Status: RECRUITING
-
Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
NCT01203631 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease
NCT04655807 ·Status: WITHDRAWN ·Phase: PHASE2
-
Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
NCT03464136 ·Status: COMPLETED ·Phase: PHASE3
-
Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease
NCT00101946 ·Status: COMPLETED ·Phase: PHASE2
-
Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients
NCT06408935 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease
NCT03677648 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
NCT01369342 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
NCT06754891 ·Status: RECRUITING ·Phase: PHASE1