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Active, not recruitingNCT04445363AAUpdated Mar 6, 2024

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

A Phase 1/2 interventional study of Jaktinib hydrochloride cream and Placebo in Alopecia Areata(AA), sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 1/2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Alopecia Areata(AA)
03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's enrollment of 160 is above the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd is the lead sponsor of 82 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 \~ 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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    Cohort 1,0.5% Bid

    Jaktinib hydrochloride cream 0.5% concentration, twice daily

    Drug: Jaktinib hydrochloride cream

  • Experimental
    Cohort 1,1.5% Bid

    Jaktinib hydrochloride cream 1.5% concentration, twice daily

    Drug: Jaktinib hydrochloride cream

  • Experimental
    Cohort 1,2.5% Qd

    Jaktinib hydrochloride cream 2.5% concentration, once daily

    Drug: Jaktinib hydrochloride cream

  • Experimental
    Cohort 1,2.5% Bid

    Jaktinib hydrochloride cream 2.5% concentration, twice daily

    Drug: Jaktinib hydrochloride cream

  • Placebo comparator
    Dose extension: Placebo

    Placebo, twice daily

    Drug: Placebo

  • Experimental
    Dose extension: 1.5% Bid

    Jaktinib hydrochloride cream 1.5% concentration, twice daily

    Drug: Jaktinib hydrochloride cream

  • Experimental
    Dose extension: 2.5% Bid

    Jaktinib hydrochloride cream 2.5% concentration, twice daily

    Drug: Jaktinib hydrochloride cream

Interventions

  • DrugJaktinib hydrochloride cream

    Jaktinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks

    Also known as: Jaktinib

  • DrugPlacebo

    Dose extension: Placebo

06

What researchers measure

Primary outcomes

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

    SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease.

    Time frame: at week 24

Secondary outcomes

  1. Change in Severity of Alopecia Tool (SALT) Score

    Severity of Alopecia Tool Score (SALT) calculation is based on a scoring system. The scalp is divided into the following 4 areas: 1) Vertex: 40% (0.4) of scalp surface area, 2) Right profile of scalp: 18% (0.18) of scalp surface area, 3) Left profile of scalp: 18% (0.18) of scalp surface area, and 4) Posterior aspect of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. The SALT score is the sum of percentage of hair loss in all the above-mentioned areas, so a lower number indicates a better outcome. The reported SALT score range is from a minimum of 0 (no hair loss) to a maximum of 100 (100% hair loss).

    Time frame: at baseline, at week 12 and at week 24

07

Study locations

1 site
  • The Second Xaingya Hospital，central south university
    Changsha, Hunan 410011, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04445363
Lead sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Responsible party
Sponsor
First posted
Jun 24, 2020
Start date
Aug 12, 2020
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Mar 6, 2024

Study contacts

qianjin lu, M.D.
study chair · the Second Xiangya Hospital, Central South University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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