A Phase III Study of Jaktinib in Adults With Moderate and Severe Atopic Dermatitis

Zelgen Biopharmaceuticals

Status and phase: Active, not recruiting; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Jaktinib Hydrochloride Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05526222

ZGJAK025

Details and patient eligibility

About

A multicenter, randomized, double-blind, placebo-controlled phase III clinical study of jaktinib hydrochloride tablets in the treatment of adult patients with moderate and severe atopic dermatitis

Enrollment: 443 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have fully understood the test and voluntarily signed the informed consent;
• When signing the informed consent form, the age of male or female subjects must be ≥ 18 years old;
• The onset time of atopic dermatitis was at least 1 year at the time of screening, and the subjects met the Hanifin and Rajka criteria for atopic dermatitis at the time of screening;
• For women with reproductive ability and all male subjects, during the trial period and within 6 months after the discontinuation of the trial drug, they must maintain abstinence or contraception, including but not limited to physical and drug contraception.
• The subjects were able to communicate well and agreed to follow the study and follow-up procedures.

Exclusion criteria

• The investigator considers that any subjects are not suitable to participate in the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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443 participants in 3 patient groups, including a placebo group

Jaktinib low dose

Experimental group

Description:

Low dose

Treatment:

Drug: Jaktinib Hydrochloride Tablet

Jaktinib high dose

Experimental group

Description:

High dose

Treatment:

Drug: Jaktinib Hydrochloride Tablet

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Jaktinib Hydrochloride Tablet