A Phase 3 interventional study of Afimkibart and Placebo in Moderately to Severely Active Crohns Disease, sponsored by Hoffmann-La Roche. Recruiting at 203 sites in 27 countries. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Exclusion Criteria:
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Drug: Afimkibart
Participants will receive placebo IV followed by afimkibart SC injection.
Drug: Placebo
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Also known as: PF-06480605, RVT-3101, RG6631, RO7790121
Placebo matching IV afimkibart.
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Time frame: At Week 12
Percentage of Participants with Endoscopic Response
Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Time frame: At Week 12
Percentage of Participants with Symptomatic Remission
Percentage of participants with the daily number of liquid or very soft stools \<=2.8 and the average of daily abdominal pain scores in the past week \<=1, with neither being greater than baseline.
Time frame: At Week 12
Percentage of Participants with Endoscopic Remission
Percentage of participants with an SES-CD of 0 to 4 with a decrease from baseline \>=2 and no subscore \>1.
Time frame: At Week 12
Percentage of Participants with Ulcer-free Endoscopy
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Time frame: At Week 12
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)
Daily average number of liquid or very soft stools over 7 days.
Time frame: Baseline through Week 12
Average of Daily Abdominal Pain Scores in the Past Week (APS)
The average daily rating of abdominal pain in the past 7 days. The pain is assessed on a scale of 0-3 with 0 indicating no pain and 3 indicating severe pain.
Time frame: Baseline through Week 12
Bowel Urgency
Bowel urgency from baseline through week 12 and. Bowel urgency is a single-item self-reported assessment of sudden or immediate need to have a bowel movement in the past 24 hours. The item response is reported on a 4-point Likert scale, from "None" to "Severe."
Time frame: Baseline to Week 12
Fatigue
Fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12. FACIT-F is a 13-item self-reported assessment of fatigue. Each item response option indicates the degree to which a given statement describing the level or impact of fatigue applies in the past 7 days. Response options are graded on a 5-point Likert-type scale, from "Not at all" to "Very much."
Time frame: Baseline to Week 12
Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Change in IBDQ score from baseline to week 12. The IBDQ is a 32-item questionnaire that measures four domains: bowel symptoms (10 questions); systemic symptoms (5 questions); emotional function (12 questions); and social function (5 questions). The total score ranges from 32-224, with a higher score indicating a better quality of life.
Time frame: Baseline to Week 12
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving a CDAI score of \<150 at Week 12 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Time frame: At Week 12
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving a decrease in SES-CD of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Time frame: At Week 12
Percentage of Participants with Clinical Response
Percentage of participants with a decrease \>=100 in CDAI from baseline.
Time frame: At Week 12
Percentage of Participants with Symptomatic Response
Percentage of participants with a decrease \>=30% in both SF and APS, with neither being greater than baseline.
Time frame: At Week 12
Overall Change in CD Symptoms
Overall change in CD symptoms, as measured by the Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 6 and 12. PGIC measures overall change in Crohn's disease symptoms from "Much better" to "Much worse".
Time frame: Baseline to Weeks 2, 6 and 12
Overall Severity in CD Symptoms
Overall severity in CD symptoms, as measured by the Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 6 and 12. PGIS measures severity of Crohn's disease symptoms from "None" to "Very severe".
Time frame: Baseline to Weeks 2, 6 and 12
Change in General Well-being
The average daily rating of general well-being in the past 7 days. Well-being is assessed on a scale of 0-4 with 0 indicating generally well and 4 indicating terrible.
Time frame: Baseline through Week 12
Incidence and Severity of Adverse Events (AEs)
Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
Time frame: Up to 30 Weeks after Baseline
Presence of Draining Fistulas
Fistulas will be assessed for draining or closed status, where closed fistulas will be assessed by the investigator as no longer draining.
Time frame: Baseline through Week 12
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