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

NCT04445363 | Active Not Recruiting Phase 1

• 1 other identifier: ZGJAKT001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alopecia Areata(AA)

Outcome Measures

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.

  at week 24

Secondary Outcomes (1)

• Change in Severity of Alopecia Tool (SALT) Score

  at baseline, at week 12 and at week 24

Study Arms (7)

Cohort 1,0.5% Bid

EXPERIMENTAL

Jaktinib hydrochloride cream 0.5% concentration, twice daily

Drug: Jaktinib hydrochloride cream

Cohort 1,1.5% Bid

EXPERIMENTAL

Jaktinib hydrochloride cream 1.5% concentration, twice daily

Drug: Jaktinib hydrochloride cream

Cohort 1,2.5% Qd

EXPERIMENTAL

Jaktinib hydrochloride cream 2.5% concentration, once daily

Drug: Jaktinib hydrochloride cream

Cohort 1,2.5% Bid

EXPERIMENTAL

Jaktinib hydrochloride cream 2.5% concentration, twice daily

Drug: Jaktinib hydrochloride cream

Dose extension: Placebo

PLACEBO COMPARATOR

Placebo, twice daily

Drug: Placebo

Dose extension: 1.5% Bid

EXPERIMENTAL

Jaktinib hydrochloride cream 1.5% concentration, twice daily

Drug: Jaktinib hydrochloride cream

Dose extension: 2.5% Bid

EXPERIMENTAL

Jaktinib hydrochloride cream 2.5% concentration, twice daily

Drug: Jaktinib hydrochloride cream

Interventions

Jaktinib hydrochloride cream DRUG

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

Also known as: Jaktinib

Cohort 1,0.5% Bid; Cohort 1,1.5% Bid; Cohort 1,2.5% Bid; Cohort 1,2.5% Qd; Dose extension: 1.5% Bid; Dose extension: 2.5% Bid

Placebo DRUG

Dose extension: Placebo

Dose extension: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The Second Xaingya Hospital，central south university

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• qianjin lu, M.D.

  The Second Xiangya Hospital, Central South University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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%, once daily(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).

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 24, 2020
• Study Start: August 12, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

CN (1)