Crohns DiseasePhase 2TAHOENCT05910528
Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease
A Phase 2 study testing Afimkibart in people with Crohns Disease, run by Hoffmann-La Roche at 11 sites in 4 countries.
Trial summary
This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, RVT-3101) in adult participants with moderate to severe active Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohns Disease
- What is being tested?
- Afimkibart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 24 Jul 2023to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderately to severely active CD as defined by CDAI and SES-CD, assessed by central read
- Elevated very soft or liquid stool frequency and/or abdominal pain
- Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy
Who cannot join
- Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
- Short gut syndrome
- Presence of an ostomy or ileoanal pouch
- Bowel resection or diversion with ~6-months
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States5 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047
Digestive Health Specialists
Dothan, Alabama, 36305
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518
I.H.S Health Northwell Health
Kissimmee, Florida, 34741
France3 sites
CHU de Nantes
Nantes, 44093
Institut des MICI, Clinique Ambroise Paré
Neuilly-sur-Seine, 92200
CHRU de Nancy Brabois
Vandœuvre-lès-Nancy, 54500
Poland2 sites
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
About this study
Official title: A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RO7790121 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease
This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, RVT-3101) in adult participants with moderate to severe active Crohn's disease.
- Conditions
- Crohns Disease
- Being tested
- Afimkibart
- Keywords
- Crohns Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfimkibartDrug
Also called RO7790121, RVT-3101, PF-06480605
Afimkibart will be administered during the Induction, Maintenance and OLE period.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence A; Drug: Afimkibart (RO7790121) Induction dose A, Maintenance dose and OLE dose | Experimental | Not described Receives: Drug: Afimkibart |
| Treatment Sequence B; Drug: Afimkibart (RO7790121) Induction dose B, Maintenance dose and OLE dose | Experimental | Not described Receives: Drug: Afimkibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and AE Leading to Discontinuation
Measured: Until end of study, approximately 5 years
Secondary outcomes (4)
Proportion of Participants Achieving Endoscopic Response
Endoscopic response defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) >=50% from Baseline at Week 14
Measured: Week 14
Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI)
Clinical remission defined as CDAI <150 at Week 14
Measured: Week 14
Proportion of Participants Achieving Clinical Remission by Patient Reported Outcome 2 (PRO2)
Clinical remission by PRO2 defined as average daily very soft or liquid stool frequency (SF) <= 2.8 and abdominal pain (AP) score <=1, and not worse than Baseline at Week 14.
Measured: Week 14
Trough Concentration (Ctrough)
Measured: Up to Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start24 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohns DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910528
- Sponsor's protocol ID
- GA45392
- Other IDs
- 2023-504265-23-00, 2023
- Acronym
- TAHOE
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RO7790121 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT05910528
- Acronym / sponsor ID
- TAHOE / GA45392
- Conditions
- Crohns Disease
- Keywords
- Crohns Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, RVT-3101) in adult participants with moderate to severe active Crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence A; Drug: Afimkibart (RO7790121) Induction dose A, Maintenance dose and OLE dose | Experimental | Drug: Afimkibart |
| Treatment Sequence B; Drug: Afimkibart (RO7790121) Induction dose B, Maintenance dose and OLE dose | Experimental | Drug: Afimkibart |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderately to severely active CD as defined by CDAI and SES-CD, assessed by central read
- Elevated very soft or liquid stool frequency and/or abdominal pain
- Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy
Key exclusion criteria (4 listed)
- Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
- Short gut syndrome
- Presence of an ostomy or ileoanal pouch
- Bowel resection or diversion with ~6-months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfimkibartAlso: RO7790121, RVT-3101, PF-06480605Afimkibart will be administered during the Induction, Maintenance and OLE period. | Drug | Treatment Sequence A; Drug: Afimkibart (RO7790121) Induction dose A, Maintenance dose and OLE dose, Treatment Sequence B; Drug: Afimkibart (RO7790121) Induction dose B, Maintenance dose and OLE dose |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and AE Leading to Discontinuation
Time frame: Until end of study, approximately 5 years
4 secondary outcomes
Proportion of Participants Achieving Endoscopic Response
Time frame: Week 14
Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI)
Time frame: Week 14
Proportion of Participants Achieving Clinical Remission by Patient Reported Outcome 2 (PRO2)
Time frame: Week 14
Trough Concentration (Ctrough)
Time frame: Up to Week 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afimkibart in people with Crohns Disease, run by Hoffmann-La Roche at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, France, Poland, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and AE Leading to Discontinuation (time frame: Until end of study, approximately 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.