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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    120
  • sponsor
    Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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Updated on 1 April 2021
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areata alopecia

Summary

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

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.

Details
Condition Alopecia Areata, Alopecia, Alopecia, Male Pattern Baldness, Hair Loss, Male Pattern Baldness, Hair Loss, areata alopecia
Treatment Placebo, Jacatinib hydrochloride cream
Clinical Study IdentifierNCT04445363
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Last Modified on1 April 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

~ 65 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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