- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04435392
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410008
- The Second Xiangya Hospital of Central South University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
|
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:
|
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:
|
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:
|
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:
|
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:
|
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
Investigators
- Principal Investigator: Qianjin Lu, PhD, Central South University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZGJAKT002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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