A Study With Jaktinib Hydrochloride Cream Applied Topically to Subjects With Alopecia Areata

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Brief Title

A Study With Jaktinib Hydrochloride Cream Applied Topically to Subjects With Alopecia Areata

Official Title

A Phase I/II Study Of The Efficacy,Safety and Pharmacokinetics Of Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Alopecia Areata

Brief Summary

      This study includes a dose escalation part(phase I) and a dose extension part(phase II).
    

Detailed Description

      In phase I of this study, a multi-center, randomized, placebo parallel control design was
      adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo
      group.A total of 40 subjects are expected to be enrolled in about 4 centers.

      In phase II of this study, a multi-center, randomized, double-blind parallel,
      placebo-controlled design was adopted. Enrolled subjects were randomly assigned to the
      experimental group or the placebo group.About 120 subjects are expected to be enrolled in
      about 10 centers.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Percentage of Participants Achieving 90% Improvement of Severity of Alopecia Tool (SALT90)

Secondary Outcome

 Change in Severity of Alopecia Tool (SALT) Score

Condition

Alopecia Areata(AA)

Intervention

Jacatinib hydrochloride cream

Study Arms / Comparison Groups

 Cohort 1,0.5% Bid
Description:  Jacatinib hydrochloride cream 0.5% concentration, twice daily

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

120

Start Date

June 18, 2020

Completion Date

June 1, 2021

Primary Completion Date

December 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  18 ~ 49 years old (including boundary value), regardless of gender;

          -  Diagnosis of Alopecia Areata;

          -  Hair loss accounts for 5% ~ 49% of the total scalp area;

          -  The duration of hair loss is at least 6 months, the longest is not more than 5 years;

          -  Patients can complete treatment for at least 6 months;

          -  About Fertility needs meet the following criteria: The results of serum pregnancy
             tests performed by fertile women during screening visits must be negative, and the
             results of human chorionic gonadotropin tests performed before the initiation of the
             study drug must be negative;Women who were fertile and men who had not received
             vasectomies were required to use effective contraception throughout the study period
             beginning with the informed consent and up to six months after the last
             administration;

          -  Subjects will voluntarily participate in the study after learning about the content
             and potential adverse drug reactions and must sign an IRC-approved informed consent
             prior to beginning any examination required by the study;

          -  Subject is willing and able to comply with scheduled visits, treatment plan, study
             drug administration, and other study procedures.

        Exclusion Criteria:

          -  The following causes of hair loss should be excluded: hair loss caused by androgenic
             alopecia,syphilis, thyroid diseases, etc.

          -  Acute Diffuse and Total Alopecia of the Female Scalp;

          -  Prior history of serious chronic diseases, such as thyroid disease, liver disease,
             malnutrition, heart disease, nervous system disease, gastrointestinal dysfunction,
             tumor and mental illness, etc;

          -  Human immunodeficiency virus infection, hepatitis C virus infection, hepatitis B virus
             infection;

          -  Participated in a trial for a topical or oral JAK inhibitor;

          -  Allergic reactions to active ingredients or excipients are known or determined by the
             investigator;

          -  Receipt of treatment known to potentially affect the course of AA within last 3 month;

          -  In the opinion of the investigator , the subject is inappropriate for entry into this
             study.
      

Gender

All

Ages

18 Years - 49 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT04445363

Organization ID

ZGJAKT001


Responsible Party

Sponsor

Study Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd


Study Sponsor

, , 


Verification Date

June 2020