Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fenebrutinib · 6 trials · 3 indications
Radiologic evaluation for Gd enhancing T1 lesion rate was performed using a standardized MRI protocol at screening, and at Weeks 4, 8, and 12. All MRI scans were read by a centralized reading center for efficacy endpoints. The total number of new Gd-enhancing T1 lesions were calculated as the sum of the individual number of new lesions observed at Weeks 4, 8 and 12. The lesion rate (new lesions per scan) was estimated from a negative binomial regression model for the total number of events and was adjusted for the covariate 'presence or absence of T1 Gd+ lesions on the screening MRI'. Log-transformed number of scans were included in the negative binomial model as an "offset" variable to account for different number of scans.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any AE that can be fatal, life threatening, prolongs inpatient hospitalization, significant disability, congenital anamoly, is a significant medical event in the Investigator's judgment.
| Arm | Type | Description |
|---|---|---|
| Fenebrutinib | EXPERIMENTAL | Participants will receive oral (PO) fenebrutinib, with teriflunomide-matching placebo. |
| Teriflunomide | ACTIVE_COMPARATOR | Participants will receive PO teriflunomide, with fenebrutinib-matching placebo in a blinded fashion. |
| Ocrelizumab | ACTIVE_COMPARATOR | Participants will receive IV ocrelizumab and oral fenebrutinib-matching placebo. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive oral placebo. |
| Single Oral Solution Dose | EXPERIMENTAL | Single 200-mg (approximately 100-µCi) oral solution dose of \[14C/12C\]-fenebrutinib under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| Fenebrutinib | DRUG | Participants will receive fenebrutinib. |
| Teriflunomide | DRUG | Participants will receive teriflunomide. |
| Placebo | DRUG | Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo. |
| Ocrelizumab | DRUG | Participants will receive ocrelizumab. |
| Placebo matched to ocrelizumab | DRUG | Participants will receive ocrelizumab-matching placebo. |
| Placebo matched to fenebrutinib | DRUG | Participants will receive fenebrutinib-matching placebo |
Inclusion Criteria: * Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening * A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria * Ability to complete the 9-hole Peg Test (9-HPT) for each hand in \< 240 seconds * Ability to perform the Timed 25-foot Walk Test (...
Fenebrutinib is an investigational small molecule being studied for multiple sclerosis, including relapsing multiple sclerosis and primary progressive multiple sclerosis. It is also being evaluated in healthy participants for safety and tolerability. Fenebrutinib is not approved and remains in clinical development.
Fenebrutinib is a kinase inhibitor, belonging to the -tinib class of drugs. It targets Bruton's tyrosine kinase (BTK), an enzyme involved in B-cell and microglial signaling. By inhibiting BTK, Fenebrutinib may modulate immune responses implicated in multiple sclerosis pathology.
Fenebrutinib is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is conducting clinical trials to evaluate the drug's safety and efficacy in multiple sclerosis indications.
Fenebrutinib is in Phase 3 clinical development for relapsing multiple sclerosis and primary progressive multiple sclerosis. A Phase 2 trial in relapsing multiple sclerosis is also active. It is not FDA approved and remains investigational.
Fenebrutinib has four trials listed on ClinicalTrials.gov. NCT04544449 is a Phase 3 study comparing it with ocrelizumab in primary progressive MS. NCT04586010 is a Phase 3 study versus teriflunomide in relapsing MS. NCT05119569 is a Phase 2 study in relapsing MS. NCT03596632 is a completed Phase 1 healthy volunteer study.
Fenebrutinib is a distinct investigational drug and is not known to be the same as any other approved medication. It is being studied as a monotherapy in multiple sclerosis trials, and no alternative names have been reported.