Clinical trial NCT04445363: A Study With Jaktinib Hydrochloride Cream Applied Topically to Subjects With Alopecia Areata
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Alopecia Areata(AA)
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2020-06-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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%, 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants Achieving 90% Improvement of Severity of Alopecia Tool (SALT90)
timeFrame: at week 24
Secondary outcomes:
measure: Change in Severity of Alopecia Tool (SALT) Score
timeFrame: at baseline, at week 12 and at week 24
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xaingya Hospital，central south university
state: Hunan
Study officials:
affiliation: the Second Xiangya Hospital, Central South University
name: qianjin lu, M.D.
role: STUDY_CHAIR
References: