PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA
NCT04517864
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
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Descriptive Information | |||||
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Brief Title ICMJE | PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA | ||||
Official Title ICMJE | A PHASE 2a, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY INVESTIGATING THE SAFETY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA | ||||
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). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Other | ||||
Condition ICMJE | Alopecia Areata | ||||
Intervention ICMJE |
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Study Arms ICMJE |
| ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 15, 2023 | ||||
Estimated Primary Completion Date | March 23, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
| ||||
Listed Location Countries ICMJE | Australia, Canada, Poland, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04517864 | ||||
Other Study ID Numbers ICMJE | B7981037 2020-001509-21 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
| ||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |