Jaktinib Hydrochloride Cream For Atopic Dermatitis

NCT ID: NCT04435392

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2022-09-08

Brief Summary

This study includes a dose escalation part and a dose extension part.

Detailed Description

In the dose-increasing part, a multicenter, dose-increasing, randomized, double-blind, placebo-parallel control design was adopted. Subjects were enrolled into different dose groups in sequence according to the inclusion sequence, and each group was scheduled to give the drug for 8 weeks.Subjects in each group were observed for 4 weeks after administration. When the number of ≥2 grade drug-related adverse events (cases) was less than 50%, subjects in the next group could be enrolled.Otherwise, IDMC will decide whether to continue the next set of tests.Subjects in each group were randomly assigned to receive either Jaktinib cream (6 cases) or placebo (2 cases) in a ratio of 3 to 1.A total of 32 subjects are expected to be enrolled in 6 centers.

The dose expansion was a multicenter, randomized, double-blind, placebo-parallel control design in which subjects were randomly assigned to 3 groups (1 placebo group and 2 experimental drugs group).It is estimated that a total of 60 subjects will be enrolled in about 15 centers. This part is divided into two stages.Stage 2 test (9 ~ 16 weeks) : Extension test.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 1: Cohort 1, 0.5% Jaktinib Bid

Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 0.5% Cream will be applied topically twice daily.

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Cream

Intervention Type: DRUG

Subjects in each group were scheduled to give the drug for 8 weeks.

Placebo

Intervention Type: DRUG

Placebo

Part 1: Cohort 2,1.5% Jaktinib Bid

Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 1.5% Cream will be applied topically twice daily.

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Cream

Intervention Type: DRUG

Subjects in each group were scheduled to give the drug for 8 weeks.

Placebo

Intervention Type: DRUG

Placebo

Part 1: Cohort 3, 2.5% Jaktinib Qd

Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically Once daily.

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Cream

Intervention Type: DRUG

Subjects in each group were scheduled to give the drug for 8 weeks.

Placebo

Intervention Type: DRUG

Placebo

Part 1: Cohort 4, 2.5% Jaktinib Bid

Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically twice daily.

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Cream

Intervention Type: DRUG

Subjects in each group were scheduled to give the drug for 8 weeks.

Placebo

Intervention Type: DRUG

Placebo

Dose extension: Vehicle Control

the Vehicle Control cream will be applied topically twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Dose extension: low-dose group, X%

X% based on results of part 1. The Jaktinib Hydrochloride X% Cream will be applied topically twice daily

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Cream

Intervention Type: DRUG

Subjects in each group were scheduled to give the drug for 8 weeks.

Dose extension: high-dose group, Y%

Y% based on results of part 1. The Jaktinib Hydrochloride Y% Cream will be applied topically twice daily

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Cream

Intervention Type: DRUG

Subjects in each group were scheduled to give the drug for 8 weeks.

Interventions

Jaktinib Hydrochloride Cream

Subjects in each group were scheduled to give the drug for 8 weeks.

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Jaktinib

Eligibility Criteria

Inclusion Criteria

• 18~ 65 years old (including boundary value), gender is not limited;
• Have a clinical diagnosis of atopic dermatitis;
• Have a PGA(Physician's Global Assessment) score of 2 (mild) or 3 (moderate) at baseline;
• The total area of atopic dermatitis is about 10%~20% of the total area of the body surface at baseline.

Exclusion Criteria

• Evidence of certain skin conditions/infections at baseline;
• Have certain laboratory abnormalities at baseline;
• Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception;
• Other conditions that the investigators considered inappropriate to participate in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qianjin Lu, PhD

Role: PRINCIPAL_INVESTIGATOR

Central South University

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

ZGJAKT002

Identifier Type: -

Identifier Source: org_study_id