A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Phase 3RecruitingNCT07577843

Janssen Research & Development, LLC460 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

460

Conditions

Crohn Disease

Interventions

JNJ-78934804DRUG

JNJ-78934804 will be administered subcutaneously.

GuselkumabDRUG

Guselkumab will be administered subcutaneously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * 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 Exclusion criteria: * 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 * Currently has or is suspected of having an abscess

Locations (142)

Outcomes

Primary Outcomes

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 48

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 48

Secondary Outcomes

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 48

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.

Central Contacts

Study Contact

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Clinnova Research

Anaheim, California, United States

RECRUITING

Gastro SB Clinic

Chula Vista, California, United States

RECRUITING

United Medical Doctors

Los Alamitos, California, United States

RECRUITING

Medical Associates Research Group, Inc.

San Diego, California, United States

RECRUITING

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

RECRUITING

Florida Research Center Inc.

Lakewood Rch, Florida, United States

RECRUITING

Sanchez Clinical Research, Inc

Miami, Florida, United States

RECRUITING

GCP Clinical Research

Tampa, Florida, United States

RECRUITING

Atlanta Gastroenterology Specialists

Suwanee, Georgia, United States

RECRUITING

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky, United States

RECRUITING

...and 132 more locations

Time frame: At Week 48

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 48

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 48

Percentage of Participants with Histologic-Endoscopic Remission at Week 48

Histologic-endoscopic remission at week 48 is defined as achieving a combination of histologic remission and endoscopic remission at Week 48. Histologic remission is defined as absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, or ulcerations or granulation tissue as assessed by the Robarts Histopathology Index. 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.

Time frame: At Week 48

Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48

IBDQ response at Week 48 is defined as an improvement of at least 16 points in the IBDQ total score from baseline at Week 48. IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate disease-specific health related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, AP), systemic function (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

Time frame: At Week 48

Percentage of Participants with Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Mental Component Summary Score (MCS) Response at Week 48

PROMIS-29 MCS response at Week 48 is defined as an improvement of at least 7 points in PROMIS-29 MCS score from baseline 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). PROMIS-29 also includes an overall average pain intensity 0-10 numeric rating scale. 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

Percentage of Participants with Clinical Remission at Week 12

Clinical remission at Week 12 is defined as CDAI score \<150 at Week 12. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

Time frame: At Week 12

Percentage of Participants with Endoscopic Response at Week 12

Endoscopic response at Week 12 is defined as greater than (\>) 50 percent (%) improvement from baseline in SES-CD score at Week 12 or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

Time frame: At Week 12

Number 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