A Long-Term Extension Study to Evaluate the Safety and Efficacy of Ritlecitinib in Participants With Severe AA Who Have Completed Studies B7981027 or B7981031

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2025-10-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the long-term safety and tolerability of ritlecitinib in pediatric participants with severe AA who have completed the studies B7981027 or B7981031.

Secondary objectives 2

1. To evaluate the long-term efficacy of ritlecitinib and durability of response in pediatric participants with severe AA who have completed the studies B7981027 or B7981031.
2. To evaluate change in psychological/psychosocial status and neuro-psychological/cognitive development status

Conditions and MedDRA coding

Alopecia areata

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-002451-PIP01-18

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 2

1. a)For participants originating from Study B7981031: 1.Participants with AA (including alopecia totalis [AT] and alopecia universalis [AU]) who completed the B7981031 study. 2. At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits.
2. b)For participants originating from Study B7981027: 3. Participants with AA (including AT and AU) who completed the B7981027 study.

Exclusion criteria 8

1. a)Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study B7981028: 1.During Study B7981027 or in the period between the last dose of study intervention in Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol.
2. 2. Study participants discontinued from Study B7981027 due to issues other than safety-related events and considered by the investigator for enrolment in Study B7981028 must have resolution of the issue(s) resulting in discontinuation from the parent study prior to enrolment in Study B7981028.
3. b)Exclusion criteria for participants originating from Study B7981031 or from Study B7981027 with >30 Days between last dose in Study B7981027 and first visit of Study B7981028: 1. During Study B7981031 or Study B7981027 or in the period between the last dose of study intervention in Study B7981031 or Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol.
4. 2. Any present malignancies or history of malignancies or lymphoproliferative disorders.
5. 3. Evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection.
6. 4. History (one or more episodes) of severe or serious cytomegalovirus (CMV), herpes zoster (shingles) or disseminated herpes simplex.
7. 5. Any infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant within prior 3 months.
8. 6. Infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • Incidence of treatment-emergent adverse events (AEs). • Incidence of serious AEs (SAEs) and AEs leading to permanent discontinuation from the study.

Secondary endpoints 5

1. • Response based on achieving absolute Severity of Alopecia Tool (SALT) score ≤10 at all visits. • Response based on achieving absolute SALT score ≤20 at all visits • Change from baseline (CFB) in SALT score at all visits. • Response based on achieving at least 2 grade improvement or a score of 3 in eyebrow assessment (EBA) score at all visits in participants with an abnormal EBA at baseline.
2. • Response based on achieving at least 2 grade improvement or a score of 3 in eyelash assessment (ELA) score at all visits in participants with an abnormal ELA at baseline. • Patient Global Impression of Change (PGI-C) response defined as score of “moderately improved or greatly improved” at all time points.
3. • CFB in Patient Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms T-score at all visits. • CFB in PROMIS Parent Proxy Anxiety Symptoms T-score at all visits.
4. • CFB in Behavior Rating Inventory of Executive Function®2 (BRIEF®2) T-scores for the three index scores (Behavior Regulation Index [BRI], Emotional Regulation Index [ERI], Cognitive Regulation Index [CRI]) at all visits.
5. • CFB in modified Children's Dermatology Life Quality Index (CDLQI) total score at all visits. • CFB# in Wechsler Intelligence Scale for Children® Fifth Edition (WISC-V) at end of study (Month 36).

Investigational products

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

Test 2

Placebo 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 19

Locations

5 EU/EEA countries · 33 investigational sites

By country

Investigational sites

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 61 files

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

Application history

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