Long-term treatment of moderate to severe atopic dermatitis with jaktinib hydrochloride
A Phase III Extended Clinical Trial of Long-term Safety and Efficacy of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis
This study is testing if jaktinib hydrochloride tablets can safely help people with moderate to severe atopic dermatitis feel better over a longer period of time.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Drugs / interventions | jaktinib |
| Locations | 2 sites (Beijing, Beijing and 1 other locations) |
| Trial ID | NCT05676242 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of jaktinib hydrochloride tablets for patients with moderate to severe atopic dermatitis. Participants who previously received treatment in the ZGJAK025 trial will continue with the same dosage, while those who received a placebo will be randomly assigned to receive either 100mg or 75mg of the drug or a placebo. The treatment will be administered on an empty stomach, with a maximum duration of 36 weeks. The study focuses on long-term outcomes and patient compliance to assess the benefits of the medication.
Who should consider this trial
Good fit: Ideal candidates are individuals who have completed the ZGJAK025 trial and are experiencing moderate to severe atopic dermatitis.
Not a fit: Patients who have experienced severe adverse events related to the test drug or are deemed unsuitable by the investigator will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of moderate to severe atopic dermatitis for patients.
How similar studies have performed: Other studies have shown promise in the treatment of atopic dermatitis with similar approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing and 1 other locations
- Peking University People's Hospital — Beijing, Beijing, China (Recruiting)
- Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College — Nanjin, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Cong Zhang
- Email: zhangc@zelgen.com
- Phone: +86-0512-57018310
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.