We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445363
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : November 29, 2022
Sponsor:
Information provided by (Responsible Party):
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study includes a dose escalation part(phase I) and a dose extension part(phase II).

Condition or disease Intervention/treatment Phase
Alopecia Areata(AA) Drug: Jacatinib hydrochloride cream Drug: Placebo Phase 1 Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

In phase I of this study, Forty enrolled subjects were randomly assigned to four groups at 1:1:1:1. (1) concentration of 0.5%, twice daily (Bid) group; (2) concentration of 1.5%, bid group; (3) concentration of 2.5%, oncedaily(Qd) group; (4) concentration of 2.5%, bid group.Ten subjects in each group were randomly assigned to receive jacatinib hydrochloride cream (8 cases) and placebo (2 cases) at 4:1, respectively,The duration of administration was 24 weeks.

In phase II of this trial, 120Enrolled subjects are randomly assigned to 3 groups (placebo bid group,concentration of 1.5% bid group and concentration of 2.5% bid group).
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 12, 2020
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cohort 1,0.5% Bid
Jacatinib hydrochloride cream 0.5% concentration, twice daily
 Drug: Jacatinib hydrochloride cream
Jacatinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks
Other Name: Jacatinib
Experimental: Cohort 1,1.5% Bid
Jacatinib hydrochloride cream 1.5% concentration, twice daily
 Drug: Jacatinib hydrochloride cream
Jacatinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks
Other Name: Jacatinib
Experimental: Cohort 1,2.5% Qd
Jacatinib hydrochloride cream 2.5% concentration, once daily
 Drug: Jacatinib hydrochloride cream
Jacatinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks
Other Name: Jacatinib
Experimental: Cohort 1,2.5% Bid
Jacatinib hydrochloride cream 2.5% concentration, twice daily
 Drug: Jacatinib hydrochloride cream
Jacatinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks
Other Name: Jacatinib
Placebo Comparator: Dose extension: Placebo
Placebo, twice daily
 Drug: Placebo
Dose extension: Placebo
Experimental: Dose extension: 1.5% Bid
Jacatinib hydrochloride cream 1.5% concentration, twice daily
 Drug: Jacatinib hydrochloride cream
Jacatinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks
Other Name: Jacatinib
Experimental: Dose extension: 2.5% Bid
Jacatinib hydrochloride cream 2.5% concentration, twice daily
 Drug: Jacatinib hydrochloride cream
Jacatinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks
Other Name: Jacatinib


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of Participants Achieving 90% Improvement of Severity of Alopecia Tool (SALT90) [ Time Frame: at week 24 ]
    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.


Secondary Outcome Measures :
  1. Change in Severity of Alopecia Tool (SALT) Score [ Time Frame: at baseline, at week 12 and at week 24 ]
    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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445363


Contacts
Layout table for location contacts
Contact: qianjin lu, M.D. 13787097676 qianlu5860@gmail.com
Contact: aijun chen, M.D. 13062377863 cajhx@aliyun.com

Locations
Layout table for location information
China, Hunan
The second xaingya hospital ，central south university Recruiting
Changsha, Hunan, China, 410011
Contact: qianjin Lu, MD    13787097676    qianlu5860@gmail.com   
Contact: siqi Fu, MD    18874139898    18874139898@163.com   
Sponsors and Collaborators
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
Layout table for investigator information
Study Chair: qianjin lu, M.D. the Second Xiangya Hospital, Central South University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT04445363    
Other Study ID Numbers: ZGJAKT001
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: November 29, 2022
Last Verified: November 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical