Phase 2
Completed N=214
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Colitis, Ulcerative
Source: ClinicalTrials.gov NCT03662542 ↗
Enrolled (actual)
214
Serious AEs
2.2%
Results posted
Dec 2023
Primary outcomePrimary: Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12 — 61.1; 74.6; 83.1 Percentage of participants
Summary
The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12 |
61.1; 74.6; 83.1 | — |
| SECONDARY Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12 |
22.2; 21.1; 36.6 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening
- Moderately to severely active UC as defined by Mayo score
- History of inadequate response to or failure to tolerate conventional therapy
- Has screening laboratory test results within the study protocol defined parameters
- A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
Exclusion Criteria
- Has severe extensive colitis as defined in the study protocol
- Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
- Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
- Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening)
- Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients
Data sourced from ClinicalTrials.gov (NCT03662542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.