Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Afimkibart · 12 trials · 6 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 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. |
| Afimkibart | EXPERIMENTAL | Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo IV followed by afimkibart SC injection. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Afimkibart | DRUG | Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection. |
| Placebo | DRUG | Placebo matching IV afimkibart. |
| 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. |
Inclusion Criteria: * Body weight \>= 10 kilogram (kg) * Active CD confirmed by endoscopy (ileocolonoscopy) * Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \>= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) \>=6 (or \>=4 for isolated...
Afimkibart is an investigational small molecule being developed by Roche Holding AG (RHHBY) for multiple inflammatory conditions. Its target indications include active ulcerative colitis, atopic dermatitis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, and rheumatoid arthritis. It is currently in clinical development and has not been approved by regulatory authorities.
The molecular target of Afimkibart has not been disclosed in available information. It is described as a small molecule therapeutic, but its specific mechanism of action is not publicly detailed. Clinical trials are evaluating its efficacy and safety in conditions such as atopic dermatitis, rheumatoid arthritis, and inflammatory bowel diseases.
Afimkibart is being developed by Roche Holding AG, a multinational healthcare company traded under the ticker RHHBY. Roche is conducting clinical trials to assess the drug's safety and efficacy in various inflammatory and autoimmune conditions, including atopic dermatitis and rheumatoid arthritis.
Afimkibart is in Phase 2 clinical development. Multiple Phase 2 trials are actively recruiting or have completed enrollment, including studies in atopic dermatitis and rheumatoid arthritis. The drug is investigational and has not received FDA approval or any other regulatory approval for commercial use.
Afimkibart is being studied in several Phase 2 trials. NCT06863961 assesses its efficacy and safety in moderate to severe atopic dermatitis. NCT07137598 evaluates it in rheumatoid arthritis patients who have not responded to TNF or JAK inhibitors. NCT07223697 is a long-term extension study in atopic dermatitis, and NCT07620392 is an extension study in rheumatoid arthritis.
Yes, Afimkibart is also known as RO7790121. Clinical trial records use both names interchangeably, with RO7790121 appearing in study titles and Afimkibart as the drug name. Researchers and investors should be aware that these identifiers refer to the same investigational compound.