Jaktinib Hydrochloride Cream For Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04435392
• Other study ID #: ZGJAKT002
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 14, 2020
• Est. completion date: September 8, 2022

Study information

• Verified date: March 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Jaktinib Hydrochloride Cream
Subjects in each group were scheduled to give the drug for 8 weeks.
• Placebo
Placebo

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of Participants With Response of Clear or Almost Clear From Baseline	PGA score of 0 or 1	Treatment at 8,16 weeks