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

Primary Purpose

Alopecia Areata(AA)

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Jaktinib hydrochloride cream

Placebo

About this trial

This is an interventional treatment trial for Alopecia Areata(AA)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The second xaingya hospital ，central south universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Cohort 1,0.5% Bid

Cohort 1,1.5% Bid

Cohort 1,2.5% Qd

Cohort 1,2.5% Bid

Dose extension: Placebo

Dose extension: 1.5% Bid

Dose extension: 2.5% Bid

Arm Description

Jaktinib hydrochloride cream 0.5% concentration, twice daily

Jaktinib hydrochloride cream 1.5% concentration, twice daily

Jaktinib hydrochloride cream 2.5% concentration, once daily

Jaktinib hydrochloride cream 2.5% concentration, twice daily

Placebo, twice daily

Jaktinib hydrochloride cream 1.5% concentration, twice daily

Jaktinib hydrochloride cream 2.5% concentration, twice daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT04445363

First Posted

June 19, 2020

Last Updated

July 28, 2023

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04445363

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 12, 2020 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia Areata(AA)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

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 Jaktinib 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, 120 Enrolled subjects are randomly assigned to 3 groups (placebo bid group,concentration of 1.5% bid group and concentration of 2.5% bid group).

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1,0.5% Bid

Arm Type

Experimental

Arm Description

Jaktinib hydrochloride cream 0.5% concentration, twice daily

Arm Title

Cohort 1,1.5% Bid

Arm Type

Experimental

Arm Description

Jaktinib hydrochloride cream 1.5% concentration, twice daily

Arm Title

Cohort 1,2.5% Qd

Arm Type

Experimental

Arm Description

Jaktinib hydrochloride cream 2.5% concentration, once daily

Arm Title

Cohort 1,2.5% Bid

Arm Type

Experimental

Arm Description

Jaktinib hydrochloride cream 2.5% concentration, twice daily

Arm Title

Dose extension: Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo, twice daily

Arm Title

Dose extension: 1.5% Bid

Arm Type

Experimental

Arm Description

Jaktinib hydrochloride cream 1.5% concentration, twice daily

Arm Title

Dose extension: 2.5% Bid

Arm Type

Experimental

Arm Description

Jaktinib hydrochloride cream 2.5% concentration, twice daily

Intervention Type

Drug

Intervention Name(s)

Jaktinib hydrochloride cream

Other Intervention Name(s)

Jaktinib

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Dose extension: Placebo

Primary Outcome Measure Information:

Title

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

Description

Time Frame

at week 24

Secondary Outcome Measure Information:

Title

Change in Severity of Alopecia Tool (SALT) Score

Description

Time Frame

at baseline, at week 12 and at week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

qianjin lu, M.D.

Phone

13787097676

qianlu5860@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

aijun chen, M.D.

Phone

13062377863

cajhx@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

qianjin lu, M.D.

Organizational Affiliation

the Second Xiangya Hospital, Central South University

Official's Role

Study Chair

Facility Information:

Facility Name

The second xaingya hospital ，central south university

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

qianjin Lu, MD

Phone

13787097676

qianlu5860@gmail.com

First Name & Middle Initial & Last Name & Degree

siqi Fu, MD

Phone

18874139898

18874139898@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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