A Phase 3 interventional study of Afimkibart and Placebo in Moderately to Severely Active Crohns Disease, sponsored by Hoffmann-La Roche. Recruiting at 375 sites in 38 countries. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 600 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Drug: Afimkibart
Participants will receive afimkibart IV followed by afimkibart SC injection.
Drug: Afimkibart
Participants will receive placebo IV followed by placebo SC.
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. Placebo matching SC 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 52
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 52
Percentage of Participants with Clinical Remission
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 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
Percentage of Participants with Endoscopic Remission
Percentage of participants with SES-CD=0 to 4 with decrease from baseline \>=2 and no subscore \>1 .
Time frame: At Week 52
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 52
Percentage of Participants with Corticosteroid-free Clinical Remission
Percentage of participants with clinical remission at Week 52 and no use of corticosteroids for CD at least 8 weeks prior to Week 52.
Time frame: At Week 52
Maintenance of Clinical Remission
Percentage of participants with clinical remission at both Weeks 12 and 52.
Time frame: At Weeks 12 and 52
Maintenance of Endoscopic Response
Percentage of participants with endoscopic response at both Weeks 12 and 52.
Time frame: At Weeks 12 and 52
Percentage of Participants with Clinical Remission and Endoscopic Remission at Week 52
Percentage of participants achieving a CDAI score of \<150 and SES-CD of 0 to 4 with a decrease from baseline \>=2 and no subscore \>1 at Week 52.
Time frame: At Week 52
Percentage of Participants with Ulcer-free Endoscopy
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Time frame: At Week 52
Bowel Urgency
Bowel urgency from baseline through week 12 and week 52. 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 through Week 12 and Week 52
Fatigue
Fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12 and Week 52. 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 and Week 52
Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Change in IBDQ score from baseline to week 12 and 52. 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 and Week 52
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 Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving a CDAI score of \<150 at Week 52 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 52
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 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 52
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, 12 and 52. PGIC measures overall change in Crohn's disease symptoms from "Much better" to "Much worse".
Time frame: Baseline to Weeks 2, 6, 12 and 52
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, 12 and 52. PGIS measures severity of Crohn's disease symptoms from "None" to "Very severe".
Time frame: Baseline to Weeks 2, 6, 12 and 52
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 52
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 70 Weeks after Baseline
Percentage of Participants with a 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 and Week 52
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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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Afimkibart