Long-Term PF-06651600 for the Treatment of Alopecia Areata (ALLEGROLT)

You may be able to join if

• 1.Participants must meet the following AA criteria: • Have a clinical diagnosis of AA with no other etiology of hair loss (including, but not limited to traction and scarring alopecia, telogen effluvium). Androgenetic alopecia coexistent with AA is allowed provided that the following criteria are met; • For de novo participants ≥12 to <18 years of age at the time of signing of the informed consent/assent: ≥50% terminal scalp hair loss due to AA (including AT and AU), as measured by SALT, at both the screening and Day 1 v sits which, in the opinion of the investigator, is appropriate for systemic therapy; • For de novo participants ≥18 years of age at the time of signing of the informed consent/assent and participants originating from B7931005 or B7981015 with >30 days between the index study and Study B7981032: ≥25% terminal scalp hair loss due to AA (including AT and AU), as measured by SALT, at both the screening and Day 1 visits which, in the opinion of the investigator, is appropriate for systemic therapy; • Hair loss must be carefully reviewed to verify the required percentage of terminal scalp hair loss is due to AA (ie, SALT [AA] score is ≥25% or ≥50%, as applicable). - If, in cases of concomitant AA and androgenetic alopecia, it cannot be verified that the participant has the required SALT (AA) score, then the participant must be excluded from the study. • No evidence of terminal scalp hair regrowth in areas affected by AA within 6 months of both the screening and Day 1 visits (for de novo participants only); • Current episode of terminal scalp hair loss due to AA ≤10 years (for de novo participants only). - When determining the duration of “current episode of terminal scalp hair loss”, the initiation of the current episode should be the last time when the patient had substantial scalp hair (regardless of whether that hair growth occurred spontaneously or was the result of interventional treatment).
• 2. Inclusion Criteria for All Participants Originating from B7931005 or B7981015: Participants enrolling from Study B7931005 must have: • Taken the last dose of PF-06700841 (a TYK2/JAK1 inhibitor) in Study B7931005 >12 weeks prior to the Study B7981032 Day 1 visit.
• 3. Participants enrolling from Study B7981015 must have: • Completed ≥34 weeks of study intervention.
• Inclusion Criteria for All Participants: 4. All participants must be ≥12 years of age, at the time they or their parent or guardian signs the informed consent. Participants below the age of 18 years will only be enrolled into this study if permitted by the sponsor, local competent authority, and institutional review board (IRB)/ethics committee (EC). Otherwise, only participants 18 years or older (or age by applicable reviewer) will be enrolled in those countries, regions or sites. Within the EU, subjects must be aged 18 through 74 years. Within UK, participants must be 18 years of age or older.
• 5. Male or Female: For all participants contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male participants: No contraceptive measures required. b. Female participants: - A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - Is not a woman of childbearing potential (WOCBP), See Appendix 4. OR •Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Appendix 4 during the intervention period and for at least 28 days after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. •A WOCBP must have a negative highly sensitive (Appendix 2) pregnancy test (urine or serum as required by local regulations) at the Day 1 visit before the first dose of study intervention. •If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
• 6.All participants must be capable of giving signed informed consent/assent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.