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

Active, not recruiting

Conditions

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Placebo
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.
Placebo
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.
Placebo
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.
Placebo
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
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
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
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
Time Frame: 7 days after the last dose
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
Time Frame: Treatment at 8,16 weeks
PGA score of 0 or 1
Treatment at 8,16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Qianjin Lu, PhD, Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

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 (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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