A Phase III Extended Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05526222

Atopic Dermatitis

ACTIVE_NOT_RECRUITING PHASE3

Clinical Study of Jaktinib in the Treatment of Patients With Moderate and Severe Atopic Dermatitis

NCT04539639

Atopic Dermatitis

COMPLETED PHASE2

Jaktinib Hydrochloride Cream For Atopic Dermatitis

NCT04435392

Atopic Dermatitis

COMPLETED PHASE1/PHASE2

A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis

NCT04162899

Atopic Dermatitis

COMPLETED PHASE2

A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Subjects With Atopic Dermatitis

NCT06931990

Atopic Dermatitis (AD)

NOT_YET_RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

If the enrolled subjects received the treatment of jaktinib hydrochloride tablets in the ZGJAK025 trial, they will continue to use the drug at the original dosage; If the enrolled subjects received placebo treatment in the ZGJAK025 trial, they will receive 100mg BID of jaktinib hydrochloride tablets, 75mg BID of jaktinib hydrochloride tablets or placebo at a ratio of 1:1:1 at random, and continue to take the drug on an empty stomach, with the longest continuous treatment not exceeding 36 weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Jaktinib 100mg BID

Drug: Jaktinib Hydrochloride Tablet 100mg dosage, orally administered, twice a day

Group Type EXPERIMENTAL

Jaktinib Hydrochloride Tablet

Intervention Type DRUG

Orally administered, twice a day

Jaktinib 75mg BID

Drug: Jaktinib Hydrochloride Tablet 75mg dosage, orally administered, twice a day

Group Type EXPERIMENTAL

Jaktinib Hydrochloride Tablet

Intervention Type DRUG

Orally administered, twice a day

Placebo

Drug: Placebo Orally administered, twice a day

Group Type PLACEBO_COMPARATOR

Jaktinib Hydrochloride Tablet

Intervention Type DRUG

Orally administered, twice a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Jaktinib Hydrochloride Tablet

Orally administered, twice a day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The investigator thinks that the subject can continue to benefit from participating in the extension trial;
* Fully understand the extension trial and sign the informed consent form;
* Complete the ZGJAK025 trial for 16 weeks and have good compliance;
* It is expected that the time interval between the first administration and the last administration of ZGJAK025 trial for the subject should be ≤ 4 weeks;

Exclusion Criteria

* Within 4 weeks before enrollment, there were any adverse events ≥ 3 levels related to the test drug that did not return to level 1 or normal;
* The investigator thinks that the subject is not suitable for the trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No