Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ritlecitinib
Ritlecitinib higher dose · 2 trials · 1 indication
The difference in proportions of participants with the SALT ≤20 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
The difference in proportions of participants with the SALT ≤10 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
| Arm | Type | Description |
|---|---|---|
| Ritlecitinib higher dose | EXPERIMENTAL | Participants will receive 1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule QD orally for up to 3 years. Participants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study. Those participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD. |
| Ritlecitinib lower dose | EXPERIMENTAL | Participants will receive 1 ritlecitinib lower dose capsule once a day (QD) and 1 placebo higher dose capsule QD orally for up to 3 years. Participants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study. Those participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD orally for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Ritlecitinib higher dose | DRUG | Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles. |
| Ritlecitinib lower dose | DRUG | Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles. |
| Placebo | DRUG | Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles. |
Inclusion Criteria: 1. Participants with alopecia areata (AA) (including alopecia totalis \[AT\] and alopecia universalis \[AU\]) who completed the studies B7981027 or B7981031. 2. For participants originating from Study B7981031: At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at ...
Ritlecitinib is an investigational small molecule being studied for dermatologic conditions including stable nonsegmental vitiligo, alopecia areata, and chronic spontaneous urticaria. It is also used in healthy volunteer studies to evaluate pharmacokinetics and drug formulations. The drug is in clinical development and has not been approved for any indication.
Ritlecitinib is a kinase inhibitor, belonging to the -tinib class of drugs. It works by inhibiting kinase enzymes involved in inflammatory and autoimmune signaling pathways. The specific molecular target is not disclosed in the available data, but its mechanism is consistent with other kinase inhibitors used in dermatology.
Ritlecitinib is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy across multiple dermatologic indications.
Ritlecitinib is in Phase 3 clinical development for dermatologic indications such as vitiligo and alopecia areata. It is also being studied in Phase 2 trials for chronic spontaneous urticaria and in Phase 1 trials for healthy volunteer pharmacokinetic studies. The drug remains investigational and is not FDA approved.
Ritlecitinib has been studied in four clinical trials. Completed Phase 1 trials include NCT05097716, NCT05852340, and NCT06369454, which evaluated pharmacokinetics and drug formulations in healthy volunteers. An ongoing Phase 2 trial, NCT07219615, is recruiting adults with chronic spontaneous urticaria across multiple countries.
Ritlecitinib 50 mg and Ritlecitinib 100 mg refer to specific dosage strengths of the same drug, Ritlecitinib. These higher-dose formulations are being evaluated in clinical trials for conditions like vitiligo and alopecia areata. The drug is also referred to simply as Ritlecitinib across different studies.