Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RO7790121, PF-06480605, RVT-3101, RG6631
Afimkibart · 14 trials · 7 indications
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.
Percentage of participants achieving Modified Mayo Score (mMS) \<=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.
| Arm | Type | Description |
|---|---|---|
| Afimkibart | EXPERIMENTAL | Participants will receive afimkibart administered as subcutaneous (SC) injection. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo adminsitered as SC injection. |
| Afimkibart Dose A | EXPERIMENTAL | Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection. |
| Afimkibart Dose B | EXPERIMENTAL | Participants will receive Afimkibart IV followed by Afimkibart SC. |
| Arm 1: Afimkibart | EXPERIMENTAL | Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. |
| Arm 2: Afimkibart | EXPERIMENTAL | Participants will receive afimkibart IV followed by afimkibart SC injection. |
| Arm 3: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo IV followed by placebo SC. |
| Afimkibart Group I | EXPERIMENTAL | Participants will recieve Afimkibart as subcutaneous (SC) injection. |
| Afimkibart Group II | EXPERIMENTAL | Participants will receive Afimkibart as SC injection. |
| Afimkibart Group III | EXPERIMENTAL | Participants will receive afimkibart via SC injection. |
| Treatment Sequence A; Drug: Afimkibart (RO7790121) Induction dose A, Maintenance dose and OLE dose | EXPERIMENTAL | - |
| Treatment Sequence B; Drug: Afimkibart (RO7790121) Induction dose B, Maintenance dose and OLE dose | EXPERIMENTAL | - |
| Afimkibart Treatment and CYP Cocktail Group | EXPERIMENTAL | Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase. |
| RO7790121 | EXPERIMENTAL | Particiapants will receive RO7790121 via intravenous (IV) infusion followed by subcutaneous (SC) injections. |
| Name | Type | Description |
|---|---|---|
| Afimkibart | DRUG | Afimkibart will be administered as SC injection. |
| Placebo | DRUG | Placebo will be administered as SC injection. |
| Caffeine | DRUG | Caffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. |
| Warfarin | DRUG | Warfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. |
| Omeprazole | DRUG | Omeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. |
| Dextromethorphan | DRUG | Dextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. |
| Midazolam | DRUG | Midazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. |
| Vitamin K | OTHER | Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol. |
| RO7790121 | DRUG | Participants will be administered RO7790121 via IV infusion on Day 1, and Weeks 2, 6 and 10. Participants will then be administered RO7790121 SC injections every four weeks (Q4W) from week 14 up to and including Week 50. |
Inclusion Criteria: * Confirmed diagnosis of UC. * Moderately to severely active UC assessed by modified Mayo Score (mMS). * Bodyweight \>= 40 kilogram (kg). * Up to date with colorectal cancer (CRC) screening performed according to local standards. * Demonstrated inadequate response, loss of respo...
Afimkibart is an investigational small molecule drug developed by Roche Holding AG for inflammatory and metabolic conditions. It is being studied in ulcerative colitis, Crohn's disease, atopic dermatitis, MASH, and rheumatoid arthritis. Afimkibart is also known as RO7790121. It remains in clinical development and is not established as an approved therapy.
Afimkibart is being studied for moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease, including pediatric Crohn's disease. Research programs also cover atopic dermatitis, MASH, and rheumatoid arthritis. These are investigational uses under clinical study, not approved indications.
Roche Holding AG develops Afimkibart, which carries the company code RO7790121. Roche trades on the OTC market under the ticker RHHBY. The company sponsors the clinical trial program evaluating the drug across gastrointestinal, dermatologic, metabolic, and rheumatologic conditions.
Afimkibart is in Phase 1 development overall, with individual studies spanning Phase 1 through Phase 3. Four trials are active, including a Phase 3 induction study in ulcerative colitis and a Phase 3 pediatric Crohn's disease study. No trials have been completed. Afimkibart is investigational and not FDA approved.
Afimkibart trials include NCT07846683, a Phase 3 induction study in moderately to severely active ulcerative colitis, and NCT07298421, a Phase 3 study in children with Crohn's disease. NCT07665723 is a Phase 1 drug interaction study in ulcerative colitis, and NCT07620392 is a Phase 2 extension study in rheumatoid arthritis.
Yes, Afimkibart and RO7790121 refer to the same investigational drug from Roche Holding AG. RO7790121 is the company designation, while Afimkibart is the drug's name. Both terms appear in connection with the same clinical trial program in ulcerative colitis, Crohn's disease, and related conditions.