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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

9 Jul 2020 → 26 Feb 2026

Decision date (initial)

2024-06-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Pfizer Inc.

External identifiers

EU CT number

2023-509801-59-00

EudraCT number

2019-001084-71

ClinicalTrials.gov

NCT04006457

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the long-term safety and tolerability of PF-06651600 in adult and adolescent participants with AA (Alopecia Areata).

Secondary objectives 1

1. • To evaluate the long-term safety and tolerability of PF-06651600 in adult and adolescent participants with AA.

Conditions and MedDRA coding

Alopecia areata

Regulatory references

Plan to share IPD

Yes

IPD plan description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 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. 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. 3. Participants enrolling from Study B7981015 must have: • Completed ≥34 weeks of study intervention.
4. 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. 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. 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.
7. 7.All participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
8. 8. If receiving permitted concomitant medications for any reason other than AA, participants should be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participants must be willing to stay on a stable regimen during the duration of the study (see Section 6.5).
9. 9.All participants must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.

Exclusion criteria 8

1. 1. Exclusion Criteria for Participants Originating from B7981015 with ≤30 Days between Studies (IC 1&2). 1.During Study B7981015 or in the period between the index study and Study B7981032, presence of safety events meeting discontinuation criteria in Appendix 8< Section 10.8.2 (eg, serious infections, laboratory results, ECG results).
2. 2.Discontinuation from Study B7931005 or B7981015 for safety related events. Participants discontinued from Study B7931005 or B7981015 due to issues other than safety-related events must be discussed with the sponsor prior to enrollment in Study B7981032.
3. 3. Exclusion Criteria for De Novo Participants and Those Originating from B7931005 or 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. 4.Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).
5. 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 <5 years: "Yes" answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C SSRS or any lifetime history of serious or recurrent suicidal behavior, a risk assessment must be performed, and documented, by a qualified mental health professional to assess whether it is safe for the participant to participate in the trial. c.The presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria. d.Clinically significant depression as indicated by a Patient Health Questionnaire 8 Items (PHQ 8) total score >=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. 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. 7. Exclusion Criteria for All Participants (IC7&IC8). 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. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Through the time the last participant completes the Follow-up visit or 28 days after the Month 36 visit: 1) Incidence of treatment emergent adverse events (TEAEs); 2) Incidence of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation; 3) Incidence of clinically significant abnormalities in vital signs; 4) Incidence of clinically significant abnormalities in clinical laboratory values.

Secondary endpoints 1

1. •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;

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 6

Locations

4 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications