Jaktinib Hydrochloride Cream For Atopic Dermatitis

Zelgen Biopharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: Jaktinib Hydrochloride Cream

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04435392

ZGJAKT002

Details and patient eligibility

About

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

Full 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.

Enrollment

107 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

107 participants in 7 patient groups, including a placebo group

Part 1: Cohort 1, 0.5% Jaktinib Bid

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Jaktinib Hydrochloride Cream

Part 1: Cohort 2,1.5% Jaktinib Bid

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Jaktinib Hydrochloride Cream

Part 1: Cohort 3, 2.5% Jaktinib Qd

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Jaktinib Hydrochloride Cream

Part 1: Cohort 4, 2.5% Jaktinib Bid

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Jaktinib Hydrochloride Cream

Dose extension: Vehicle Control

Placebo Comparator group

Description:

the Vehicle Control cream will be applied topically twice daily

Treatment:

Drug: Placebo

Dose extension: low-dose group, X%

Experimental group

Description: