A Phase III Extended Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis
Study Details
Study Description
Brief Summary
To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Jaktinib 100mg BID Drug: Jaktinib Hydrochloride Tablet 100mg dosage, orally administered, twice a day |
Drug: Jaktinib Hydrochloride Tablet
Orally administered, twice a day
|
| Experimental: Jaktinib 75mg BID Drug: Jaktinib Hydrochloride Tablet 75mg dosage, orally administered, twice a day |
Drug: Jaktinib Hydrochloride Tablet
Orally administered, twice a day
|
| Placebo Comparator: Placebo Drug: Placebo Orally administered, twice a day |
Drug: Jaktinib Hydrochloride Tablet
Orally administered, twice a day
|
Outcome Measures
Primary Outcome Measures
- Number and percentage of subjects with treatment emergent adverse event (TEAE) [36 weeks after the first dose]
Safety of the drug
- Number and percentage of subjects with Serious Adverse Event (SAE) [36 weeks after the first dose]
Safety of the drug
Secondary Outcome Measures
- The diachronic change in the proportion of subjects whose total Eczema area and severity index （EASI） score decreased by ≥ 75% from baseline [36 weeks after the first dose]
The proportion of subjects who reached EASI-75
- The diachronic change of the proportion of subjects whose systemic Investigator's Global Assessment （IGA） score reached 0 or 1 and decreased by ≥ 2 points from baseline [36 weeks after the first dose]
The proportion of subjects who reached IGA 0/1
- The diachronic change in the proportion of subjects whose pruritus Numerical Rating Scale （NRS） score improved by ≥ 4 points from baseline [36 weeks after the first dose]
The proportion of subjects who reached NRS4
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 11 Xizhimen South Street | Beijing | Beijing | China |
Sponsors and Collaborators
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZGJAK026