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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

443 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-14

Study Completion Date

2026-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Jaktinib low dose

Low dose

Group Type EXPERIMENTAL

Jaktinib Hydrochloride Tablet

Intervention Type DRUG

Orally administered, twice a day

Jaktinib high dose

High dose

Group Type EXPERIMENTAL

Jaktinib Hydrochloride Tablet

Intervention Type DRUG

Orally administered, twice a day

Placebo

Group Type PLACEBO_COMPARATOR

Jaktinib Hydrochloride Tablet

Intervention Type DRUG

Orally administered, twice a day

Interventions

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Jaktinib Hydrochloride Tablet

Orally administered, twice a day

Intervention Type DRUG

Eligibility Criteria

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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.