Clinical trial NCT04435392: Jaktinib Hydrochloride Cream For Atopic Dermatitis
Official title: A Phase I/II Study Of The Efficacy,Safety and PharmacokineticsOf Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Jaktinib
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2020-06-17
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear
timeFrame: 7 days after the last dose
Secondary outcomes:
measure: Proportion of Participants With Response of Clear or Almost Clear From Baseline
timeFrame: Treatment at 8,16 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Qianjin Lu, PhD
role: PRINCIPAL_INVESTIGATOR
References: