PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA (Allegro2a)
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| ClinicalTrials.gov Identifier: NCT04517864 |
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Recruitment Status :
Active, not recruiting
First Posted : August 18, 2020
Last Update Posted : June 1, 2022
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
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Brief Summary:
This is a global Phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ritlecitinib in adults aged 18 to ≤50 years of age with ≥25% scalp hair loss due to Alopecia Areata (AA).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alopecia Areata | Drug: PF-06651600 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 71 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Other |
| Official Title: | A PHASE 2a, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY INVESTIGATING THE SAFETY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA |
| Actual Study Start Date : | September 15, 2020 |
| Actual Primary Completion Date : | January 4, 2022 |
| Estimated Study Completion Date : | April 11, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Alopecia areata
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment Arm: PF-06651600
ritlecitinib 200 milligram (mg) once per day (QD) (four 50 mg tablets) for 4 weeks then ritlecitinib 50 mg tablet QD through month 24. At Month 9, participants assigned to this treatment arm will also receive 3 tablets of placebo for 4 weeks to maintain the blind with the other arm. After month 24, participants switch to 50 mg capsules, 1 QD, up to month 60.
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Drug: PF-06651600
50 mg tablet, dosed as 200 mg QD or 50 mg QD 50 mg capsule, dosed as 50 mg QD
Other Name: ritlecitinib |
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Control Arm (Placebo) followed by active therapy extension
matching comparator: placebo QD (4 tablets x 4 weeks then 1 tablet x 8 months) then ritlecitinib 200 mg QD (four 50 mg tablets) for 4 weeks then ritlecitinib 50 mg tablet QD through month 24. After month 24, participants switch to 50 mg capsules, 1 QD, up to month 60.
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Drug: Placebo
tablet, dosed as 4 tablets QD or 1 tablet QD |
Primary Outcome Measures :
- Change from baseline in I-V interwave latency on brainstem auditory evoked potential (BAEP) at a stimulus intensity of 80 decibels (dB) at Month 9. [ Time Frame: Baseline, Month 9 ]
Secondary Outcome Measures :
- Change from baseline in I-V interwave latency on BAEP at a stimulus intensity of 80dB at Months 6, 18 (aka 9E), and 24 (15E) [ Time Frame: Baseline, Months 6, 18(month 9 of active therapy extension [9E]), 24 (15E) ]
- Change from baseline in axonal dystrophy in skin punch biopsies at Month 9 and Month 24 (15E) [ Time Frame: Baseline, Months 9, 24 (15E) ]
- Change from baseline in IENFD in skin punch biopsies at Month 9 and Month 24 (15E) [ Time Frame: Baseline, Months 9, 24 (15E) ]
- Change from baseline in amplitude of wave V on BAEP at a stimulus intensity of 80 dB at Months 6, 9, 18 (9E), and 24 (15E) [ Time Frame: Baseline, Months 6, 9, 18 (9E), 24 (15E) ]
- Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB at Months 6, 9, 18 (9E) and 24 (15E) [ Time Frame: Baseline, Months 6, 9, 18 (9E), 24 (15E) ]
- Incidence of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and adverse events (AEs) leading to discontinuation [ Time Frame: Baseline through Month 60 (51E) ]
- Incidence of clinically significant abnormalities in vital signs [ Time Frame: Baseline through Month 60 (51E) ]
- Incidence of clinically significant abnormalities in clinical laboratory values [ Time Frame: Baseline through Month 60 (51E) ]
- To evaluate response to ritlecitinib measured by the Severity of Alopecia Tool (SALT) in adult participants with AA [ Time Frame: Baseline through Month 60 (51E) ]
- To evaluate the response to ritlecitinib measured by the Patient's Global Impression of Change (PGI-C) tool in adult participants with AA [ Time Frame: Baseline through Month 60 (51E) ]
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of alopecia areata, including alopecia totalis and alopecia universalis.
- At least 25% hair loss due to alopecia areata
- Must have normal hearing and normal brainstem auditory evoked potentials (BAEPs)
- Must have a normal neurological exam; can have a stable unilateral median neuropathy or ulnar neuropathy
- Signed informed consent
- Stable regimen for other medications before and during the study
Exclusion Criteria:
- Other significant medical conditions
- Occupational or recreational noise exposure
- History of peripheral neuropathy or first degree relative with a hereditary peripheral neuropathy
- HbA1c > or = 7.5% at Screening
- Recurrent or disseminated Herpes Zoster
- Active or chronic infection; or infection requiring hospitalization or IV antimicrobials within 6 months
- Active or latent (insufficiently treated) Hepatitis
- Active or latent (insufficiently treated) TB
- Concomitant medications associated with peripheral neurologic or hearing loss
- Protocol specific laboratory abnormalities
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517864
Locations
Show 38 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT04517864 |
| Other Study ID Numbers: |
B7981037 2020-001509-21 ( EudraCT Number ) |
| First Posted: | August 18, 2020 Key Record Dates |
| Last Update Posted: | June 1, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Pfizer:
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alopecia totalis alopecia universalis hair loss alopecia JAK |
ritlecitinib PF-06651600 double-blind placebo-controlled phase 2a |
Additional relevant MeSH terms:
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Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |