A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
ConditionCrohn Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score >= 220 but less than or equal to (<=) 450 and either: a. Mean daily stool frequency (SF) count >= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >= 2.0, based on the unweighted CDAI component of abdominal pain (AP)
Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria
Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies
Disqualifiers
Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC
Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study
Presence of draining (that is, functioning) stoma or ostomy
Has a history of short bowel syndrome, is missing greater than (>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention
Trial design
Design model
Parallel
Treatments tested in this trial
JNJ-78934804
DrugJNJ-78934804 will be administered subcutaneously.
Guselkumab
DrugGuselkumab will be administered subcutaneously.
Treatment groups
460 Participants
are divided into 2 treatment groupsGroup A: JNJ-78934804Experimental treatment 1 intervention
Group B: GuselkumabActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Co-Primary: Percentage of Participants with Clinical Remission at Week 48
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Time frame
At Week 482
Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48
Endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no subscore greater than (\>) 1 in any individual component. The SES-CD is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
Time frame
At Week 48Secondary outcomes
1
Percentage of Participants with Deep Remission at Week 48
Deep remission (composite endpoint) is defined as achieving both clinical remission and endoscopic remission at Week 48 at the participant level. Clinical remission is defined as a CDAI score of \<150 and Endoscopic remission is defined as a SES-CD score of \<= 4 with at least a 2-point reduction from baseline and no subscore \>1 in any individual component. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
Time frame
At Week 482
Percentage of Participants with Corticosteroid-Free (90-Day) Clinical Remission at Week 48
Corticosteroid-free (90-day) clinical remission at Week 48 is defined as clinical remission at Week 48 and not receiving corticosteroids for at least 90 days prior to Week 48. Clinical remission is defined as a CDAI score of \<150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Time frame
At Week 483
Percentage of Participants with Corticosteroid-Free (90-day) PRO-2 Remission at Week 48
Corticosteroid-free (90-day) patient-reported outcome(s) (PRO-2) remission at Week 48 is defined as an abdominal plan (AP) mean daily score less than or equal to (\<=) 1 and stool frequency (SF) mean daily score \<= 2.8, and no worsening of AP or SF from baseline, and not receiving corticosteroids for at least 90 days prior to Week 48.
Time frame
At Week 484
Percentage of Participants with Sustained Clinical Remission
Sustained clinical remission is defined as clinical remission at Week 12 and Week 48. Clinical remission is defined as CDAI score of \<150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Time frame
At Weeks 12 and 48Sponsors and contacts
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Source ClinicalTrials.gov