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

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• Colitis, Ulcerative 1,492

Colitis, Ulcerative

1,492 studies on the registry are indexed under Colitis, Ulcerative; 399 are open to participants now.

This study's planned enrollment of 644 is above the median of 71 across 1,042 interventional studies indexed under Colitis, Ulcerative.

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Study arms

• 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

• 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 · Drug: Guselkumab

Interventions

• DrugJNJ-78934804

  JNJ-78934804 will be administered subcutaneously.

  Also known as: JNJ-4804

• DrugGuselkumab

  Guselkumab will be administered subcutaneously.

  Also known as: TREMFYA

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.

   Time frame: At Week 48

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

Individual participant data

Plan to share: Yes — 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.