Jaktinib Hydrochloride Cream For Atopic Dermatitis

A Phase I/II Study Of The Efficacy,Safety and PharmacokineticsOf Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Atopic Dermatitis

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Jaktinib Hydrochloride Cream

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • The Second Xiangya Hospital Of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Placebo; Placebo; Drug: Jaktinib Hydrochloride Cream; Subjects in each group were scheduled to give the drug for 8 weeks.; Other Names: Jaktinib
Experimental: 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.	Drug: Placebo; Placebo; Drug: Jaktinib Hydrochloride Cream; Subjects in each group were scheduled to give the drug for 8 weeks.; Other Names: Jaktinib
Experimental: 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.	Drug: Placebo; Placebo; Drug: Jaktinib Hydrochloride Cream; Subjects in each group were scheduled to give the drug for 8 weeks.; Other Names: Jaktinib
Experimental: 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.	Drug: Placebo; Placebo; Drug: Jaktinib Hydrochloride Cream; Subjects in each group were scheduled to give the drug for 8 weeks.; Other Names: Jaktinib
Placebo Comparator: Dose extension: Vehicle Control; the Vehicle Control cream will be applied topically twice daily	Drug: Placebo; Placebo
Experimental: Dose extension: low-dose group, X%; X% based on results of part 1. The Jaktinib Hydrochloride X% Cream will be applied topically twice daily	Drug: Jaktinib Hydrochloride Cream; Subjects in each group were scheduled to give the drug for 8 weeks.; Other Names: Jaktinib
Experimental: Dose extension: high-dose group, Y%; Y% based on results of part 1. The Jaktinib Hydrochloride Y% Cream will be applied topically twice daily	Drug: Jaktinib Hydrochloride Cream; Subjects in each group were scheduled to give the drug for 8 weeks.; Other Names: Jaktinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear	A total PGA score of 0 or 1 or a decrease of ≥2 from baseline	7 days after the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants With Response of Clear or Almost Clear From Baseline	PGA score of 0 or 1	Treatment at 8,16 weeks

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: Qianjin Lu, PhD, Central South University

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Actual): September 8, 2022
• Study Completion (Actual): September 8, 2022

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 31, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Jaktinib
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ZGJAKT002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No