Trials Sponsors Conditions Drugs Pricing

Conditions

Cicatricial Alopecia

Keywords

AlopeciaScarring AlopeciaHair Loss

Outcome Measures

Primary Outcomes (3)

Number of Participants With Treatment-Emergent Adverse Events
The adverse event will be described and categorized as Treatment-emergent, Serious, abnormal in vital signals, and abnormal in laboratory parameters. Incidence and Severity of
Week 48
Changes From Baseline in CCL5 Gene Expression Level in Response to PF-06700841
mRNA Levels of CCL5 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline, week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 24 or week 48) to baseline.
Baseline, Week 24 and Week 48
Changes From Baseline in CXCR3(TGFB1) Gene Expression Level in Response to PF-06700841
mRNA Levels of CXCR3(TGFB1) gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline, week 24 and week 48. Changes are characterized by differences in Ct values from a specific time point (week 24 or week 48) to baseline.
Baseline, Week 24 and Week 48

Secondary Outcomes (10)

Changes From Baseline in IFN-γ Gene Expression Level in Response to PF-06700841
Baseline, Week 24 and Week 48
Changes From Baseline in CXCL9 Gene Expression Level in Response to PF-06700841
Baseline, Week 24 and Week 48
Changes From Baseline in CXCL10 Gene Expression Level in Response to PF-06700841
Baseline, Week 24 and Week 48
Changes From Baseline in IL-12RB1 Gene Expression Level in Response to PF-06700841
Baseline, Week 24 and Week 48
Changes From Baseline in STAT1 Gene Expression Level in Response to PF-06700841
Baseline, Week 24 and Week 48
+5 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Tablets without active ingredients

Drug: Placebo

PF-06700841

EXPERIMENTAL

tablets containing active drug (a combined TYK/JAK inhibitor)

Drug: PF-06700841

Interventions

PF-06700841Drug

Active study drug

Also known as: Brepocitinib

PF-06700841

PlaceboDrug

placebo comparator

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects of any gender, age 18 years or older, at the time of informed consent at Screening
Subjects who are willing and able to adhere to the study visit schedule and comply with protocol requirements.

Sponsors & Collaborators

Pfizer
Industrycollaborator
Emma Guttman
Otherlead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Related Publications (1)

David E, Shokrian N, Del Duca E, Meariman M, Dubin C, Hawkins K, Andrews E, Sikand S, Singer G, Oemar B, Estrada Y, Bose S, Pulsinelli J, Mahling P, Da Rosa JC, Ungar B, Peeva E, Guttman-Yassky E. A phase 2a trial of brepocitinib for cicatricial alopecia. J Am Acad Dermatol. 2025 Mar;92(3):427-434. doi: 10.1016/j.jaad.2024.09.073. Epub 2024 Oct 24.
PMID: 39461505DERIVED

MeSH Terms

Conditions

Alopecia

Interventions

PF-06700841

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Dr. Emma Guttman
Organization: Icahn School of Medicine at Mount Sinai

Study Officials

Emma Guttman, MD
Icahn School of Medicine at Mount Sinai
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

51 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Only designated pharmacist will have knowledge of treatment assignment
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

August 9, 2021

First Posted

October 13, 2021

Study Start

May 19, 2021

Actual (reported)

You may not qualify if:

Subject's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia.
Subject has a history of CA for ≥ 7 years since their disease onset, severe fibrosing disease, or very rapid hair loss.
Subject has a history of moderate to severe keloids on the scalp, as determined by clinical examination at screening.
Other scalp disease that may impact assessment (eg, scalp psoriasis, dermatitis, etc).
Subject is pregnant or breastfeeding. Female subjects of childbearing potential must agree to use two effective methods (one of which is a highly effective method) of contraception throughout the study and for at least 28 days after the last dose of investigational product. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study.
Participation in other studies involving investigational drug(s) within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to study entry and/or during study participation.
Active systemic diseases that may cause hair loss (eg, systemic lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).
Any Psychiatric condition in the opinion of the investigator precludes participation in the study .
Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (particularly thyroid disease which can be associated with hair loss), pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator, the subject is inappropriate for entry into this study, or unwilling/unable to comply with STUDY PROCEDURES.
Any present malignancies or history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
History of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
History of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 0.
Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 0 or superficial skin infection within 1 week prior to Day 0.
Significant trauma or major surgery within 1 month of signing informed consent.
+15 more criteria

Dual JAK1/TYK2 Inhibitor for Cicatricial Alopecia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (10)

Study Arms (2)

Placebo

PF-06700841

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (10)

Study Arms (2)

Placebo

PF-06700841

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations