Treatment of moderate to severe atopic dermatitis with jaktinib
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
This study is testing if jaktinib tablets can help adults with moderate to severe atopic dermatitis feel better and improve their skin.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 438 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Drugs / interventions | jaktinib |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05526222 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial evaluates the efficacy and safety of jaktinib hydrochloride tablets in adults suffering from moderate to severe atopic dermatitis. The study is designed as a multicenter, randomized, double-blind, placebo-controlled trial, ensuring that participants receive either the active treatment or a placebo without knowing which they are receiving. Participants must meet specific criteria related to their condition and agree to follow the study protocols. The trial aims to provide robust data on the effectiveness of jaktinib in managing this chronic skin condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of moderate to severe atopic dermatitis lasting at least one year.
Not a fit: Patients who do not meet the eligibility criteria or have conditions that the investigator deems unsuitable for participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with moderate to severe atopic dermatitis.
How similar studies have performed: Other studies have shown promise in treating atopic dermatitis with similar therapeutic approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changsha, Hunan
- 139 People's Middle Road — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Cong Zhang
- Email: zhangc@zelgen.com
- Phone: +86-0512-57018308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.