Colitis, Ulcerative
Conditions
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).
Interventions
DRUGJNJ-78934804
JNJ-78934804 will be administered subcutaneously.
DRUGGuselkumab
Guselkumab will be administered subcutaneously.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Clinical Remission at Week 48 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Clinical Remission at Week 12 | 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. |
| Percentage of Participants with Endoscopic Improvement at Week 12 | At Week 12 | Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. |
| Percentage of Participants with Mayo SF/RB Response at Week 2 | 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. |
| Percentage of Participants with Endoscopic Improvement at Week 48 | At Week 48 | Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. |
| Percentage of Participants with Corticosteroid-free (90 day) Clinical Remission at Week 48 | 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. |
| Percentage of Participants Achieving a Combination of Histologic Remission and Endoscopic Improvement at Week 48 | 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. |
| Percentage of Participants with Fatigue Response (PROMIS Fatigue Short Form 7a) at Week 48 | 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). |
| Percentage of Participants with Sustained Mayo SF Less Than or Equal to (<=) 1 and RB=0 | At Weeks 12, 24, and 48 | 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. |
| Percentage of Participants in Abdominal Pain Remission at Week 48 | At Week 48 | Percentage of participants in abdominal pain remission at week 48 will be reported. |
| Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48 | 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). |
| Percentage of Participants with PROMIS-29 Mental Component Summary (MCS) Response at Week 48 | 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. |
| Percentage of Participants with Adverse Events (AE) and Serious AEs (SAEs) | Up to approximately 3 years | 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. |
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed