A Phase 3 interventional study of Afimkibart and Placebo in Moderately to Severely Active Ulcerative Colitis, sponsored by Hoffmann-La Roche. Not yet recruiting. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).
Exclusion Criteria:
Participants will receive afimkibart administered as subcutaneous (SC) injection.
Drug: Afimkibart
Participants will receive placebo adminsitered as SC injection.
Drug: Placebo
Afimkibart will be administered as SC injection.
Also known as: PF-06480605, RVT-3101, RO7790121
Placebo will be administered as SC injection.
Percentage of Participants With Clinical Remission
Time frame: At Week 12
Change From Baseline in Stool Frequency Subscore (SFS)
The Stool Frequency Subscore (SFS) is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal)
Time frame: From Baseline up to Week 12
Change From Baseline in Rectal Bleeding Subscore (RBS)
The Rectal Bleeding Subscore (RBS) is measured on a scale from 0 (no blood seen) to 3 (blood alone passed)
Time frame: From Baseline up to Week 12
Percentage of Participants With Symptomatic Response
Time frame: At Week 4
Percentage of Participants With Endoscopic Improvement
Time frame: At Week 12 and Week 24
Percentage of Participants With Endoscopic Remission
Time frame: At Week 12 and Week 24
Percentage of Participants With Clinical Response
Time frame: At Week 12
Percentage of Participants With Histologic-Endoscopic Mucosal Improvement
Time frame: At Week 12 and Week 24
Percentage of Participants With Clinical Remission
Time frame: At Week 24
Percentage of Participants With Maintenance of Remission
Time frame: At Week 12 and Week 24
Percentage of Participants With Histologic Improvement
Time frame: At Week 24
Change From Baseline in Bowel Urgency
Bowel urgency will be assessed using two self-reported items over the past 24 hours: presence of bowel urgency (Yes/No) and severity on an 11-point numerical rating scale from 0 (no urgency) to 10 (worst possible urgency)
Time frame: From Baseline through Week 12 and Week 24
Change From Baseline in Abdominal Pain
Abdominal pain will be assessed using two self-reported items over the past 24 hours: presence of abdominal pain (Yes/No) and severity on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain)
Time frame: From Baseline through Week 12 and Week 24
Change From Baseline in Fatigue
Change in fatigue will be assessed by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue
Time frame: From Baseline through Week 12 and Week 24
Change From Baseline in Health-Related Quality of Life
Change in health-related quality of life will be assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) score. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life
Time frame: From Baseline through Week 12 and Week 24
Change From Baseline in Overall UC Symptoms
Change in overall UC symptoms will be assessed by Patient Global Impression of Change (PGIC). PGIC measures overall change in ulcerative colitis symptoms from "Much better" to "Much worse"
Time frame: Baseline, Week 2, Week 12 and Week 24
Change From Baseline in Overall Severity in UC Symptoms
Change in overall severity of UC symptoms will be assessed by Patient Global Impression of Severity (PGIS). PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe"
Time frame: Baseline, Week 2, Week 12 and Week 24
Incidence and Severity of Adverse Events (AEs)
Time frame: From Baseline up to approximately 42 Weeks
No study locations are listed for this record.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche