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NCT05526222 | RECRUITING | Atopic Dermatitis

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

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary:

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

Condition or disease

Atopic Dermatitis

Intervention/treatment

Jaktinib Hydrochloride Tablet

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 438 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2022-07-14
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2025-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Phase III Study of Jaktinib in Adults With Moderate and Severe Atopic Dermatitis

Location Details

NCT05526222

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Hunan

139 People's Middle Road

Changsha, Hunan, China, 410008