Alopecia areata MedDRA version: 20.0 Level: PT Classification code 10001761 Term: Alopecia areata System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Code: PF-06651600
Pharmaceutical Form: Tablet
INN or Proposed INN: Not available
CAS Number: Not availabl
Current Sponsor code: PF-06651600
Other descriptive name: Janus Kinase 3 inhibitor
Co
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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; •De novo participants =12 to 30 days between index study and Study B7981032: =25% terminal scalp hair loss due to AA (including AT and AU), as measured by SALT, at both screening and Day 1 which, in the opinion of the investigator, is appropriate for systemic therapy; •Hair loss must be carefully reviewed to verify 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 within 6 months of both screening and Day 1 (de novo participants only); •Current episode of terminal scalp hair loss due to AA =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. Participants =18 years (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 se
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Participants Originating from B7981015 with 30 Days between the Index Study and Study B7981032 3.Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc). 4.Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc). 5.Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria: a.Suicidal ideation associated with actual intent and a method or plan in the past year: “Yes” answers on items 4 or 5 of the Columbia Suicide Severity Rating Scale (C SSRS) (Section 8.2.9). b.For participants who had previous history of suicidal behaviors in the past >1 year to =15 (Section 8.2.10). NOTE: For any participant who has significant depression or any suicidal behavior, the participant will not be assigned to study intervention and should be referred for appropriate evaluation and treatment. 6.Have hearing loss with progression over the previous 5 years, or sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere’s disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating or progressive. •Participants originating from Study B7931005 or B7981015 with occurrences of any of the above either during the index study or between the end of the index study and Study B7981032 can only be enrolled in Study B7981032 with prior approval of the sponsor. Exclusion Criteria for All Participants 7.Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study. 8.Participation in studies other than B7931005 or B7981015 involving investigational drug(s) within 8 weeks (12 weeks for JAK inhibitors other than PF 06651600 received in Study B7931005 or B7981015) or within 5 half lives (if known), whichever is longer, prior to study entry and/or during study participation. Please see the Protocol for a complete list of exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long term safety and tolerability of PF-06651600 in adult and adolescent participants with AA ;Secondary Objective: To evaluate the long term safety and tolerability of PF-06651600 in adult and adolescent participants with AA ;Timepoint(s) of evaluation of this end point: Ongoing evaluation at intermittent timepoints until Day 1801/EOT;Primary end point(s): Through the time the last participant completes the Follow-up visit or 28 days after the Month 36 visit: •Incidence of treatment emergent adverse events (TEAEs); •Incidence of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation; •Incidence of clinically significant abnormalities in vital signs; •Incidence of clinically significant abnormalities in clinical laboratory values. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Through the time of the last participant visit: •Incidence of TEAEs; •Incidence of SAEs and AEs leading to discontinuation; •Incidence of clinically significant abnormalities in vital signs; •Incidence of clinically significant abnormalities in clinical laboratory values. •Response based on achieving absolute Severity of Alopecia Tool (SALT) score =10 through Month 36, for overall and AA SALT score; •Response based on achieving absolute SALT score =20 through Month 36, for overall and AA SALT score; •Change from baseline in SALT score through Month 36 for overall and AA SALT score; •Response based on achieving at least 75%, improvement in SALT (SALT75) from baseline baseline through Month 36 for overall and AA SALT score; •Response based on achieving at least a 2 grade improvement from baseline or a score of 3 in Eyebrow Assessment (EBA) score through Month 36; •Response based on achieving at a least 2 grade improvement from baseline or a score of 3 in Eyelash Assessment (ELA) score through Month 36. ;Timepoint(s) of evaluation of this end point: at the Month 36 or Early Termination visit | — |
Countries
Argentina, Australia, Canada, Chile, China, Colombia, Czechia, Czech Republic, Germany, Hungary, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc.
Outcome results
None listed