A Phase II Clinical Study Evaluating of ZL-82 Tablets in Atopic Dermatitis
ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChengdu Zenitar Biomedical Technology Co., Ltd
About this trial
This clinical trial aims to explore whether the drug ZL-82 tablets can be used to treat moderate to severe atopic dermatitis in adults, and to understand the safety and tolerability of the drug. The main questions that the trial intends to answer are: Can ZL-82 tablets alleviate the Eczema Area and Severity Index (EASI) score of patients? What physical problems will patients have after taking ZL-82 tablets? The researchers will compare ZL-82 tablets with placebo (a substance with a similar appearance but without drug components) to observe whether ZL-82 tablets can be used to treat moderate to severe atopic dermatitis. Participants need to take ZL-82 tablets or placebo every day for 16 weeks, and visit the hospital for a check-up every two weeks; record their own symptoms and the percentage change of EASI score relative to the baseline.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female individuals aged 18 years and above and 75 years and below (inclusive of the threshold value, based on the date of signing the ICF), with BMI >= 19 kg/m2.
Participants are fully informed of the purpose and requirements of this trial, and voluntarily sign the informed consent form.
According to the Hanifin & Rajka diagnostic criteria (≥ 3 out of 4 main 4, >= 3 out of 23 secondary symptoms, see Appendix 1), diagnosed as AD by the investigators, and with a history of AD for >= 1 year before screening.
IGA score of 3 or 4;
Disqualifiers
Allergy to the test drug or any component thereof, or allergy or intolerance to other oral Janus kinase (JAK) inhibitors.
Individuals with a history of major diseases: This includes but is not limited to those with a history of diseases in the digestive system, cardiovascular system, respiratory system, musculoskeletal system, endocrine system, nervous and mental system, hematological system, immune system disorders, thromboembolic diseases (or individuals at high risk of thromboembolism), and metabolic abnormalities, or those who have undergone major surgeries, or any other diseases or physiological conditions that the investigator deems may affect the trial results.
Family Planning: a. Pregnant or lactating women; b. Throughout the entire study period, all participants or their spouses (or partners) who have reproductive capacity must ensure to take effective contraceptive measures from the moment of signing the informed consent form until 90 days after the last administration of the drug (contraceptive measures and requirements are detailed in Appendix III); c. Those who plan to donate eggs or sperm during the trial period and within 3 months after the last administration.
Those who have a history of malignant tumors in the past, including solid tumors and hematological malignancies (excluding basal cell carcinoma and cutaneous squamous cell carcinoma that have been removed or cured).
Trial design
Design model
Parallel
Treatments tested in this trial
The high-dose group of ZL-82 tablets
DrugParticipants will take the investigational drug orally for 16 weeks, 200mg each time , once a day.
The low-dose group of ZL-82 tablets
DrugParticipants will take the investigational drug orally for 16 weeks, 100mg each time, once a day.
The placebo group
DrugThe participants will take the investigational drug orally for 16 weeks, 2 tablets each time , once a day.
Treatment groups
111 Participants
are divided into 3 treatment groupsGroup A: The high-dose group of ZL-82 tabletsExperimental treatment 1 intervention
Group B: The low-dose group of ZL-82 tabletsExperimental treatment 1 intervention
Group C: The placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Compare the percentage changes in Eczema Area And Severity Index (EASI) scores from baseline between the ZL-82 tablets dose group and the placebo group.
Time frame
At the 16th weekSecondary outcomes
1
Compare respectively the percentage changes of EASI scores from baseline in the ZL-82 tablets dose group and the placebo group
Time frame
At the 2nd, 4th, 8th and 12th weeks2
Compare respectively the proportions of participants in the ZL-82 tablets dose group and the placebo group whose EASI scores have improved by at least 50% (EASI-50), 75% (EASI-75) and 90% (EASI-90).
Time frame
At the 2nd, 4th, 8th and 12th weeks3
Compare respectively the proportions of participants in the ZL-82 tablets dose group and the placebo group who had an IGA score of 0 or 1 and showed a 2-point improvement compared to the baseline in the Investigator's Global Assessment (IGA) method.
Time frame
At the 2nd, 4th, 8th, 12th and 16th weeks4
Compare the proportions of participants whose IGA scores improved by ≥ 2 points relative to the baseline in the ZL-82 tablet dose group and the placebo group respectively.
Time frame
At the 2nd, 4th, 8th, 12th and 16th weeksOther outcomes
1
Eosinophil count
Evaluate the changes in PD biomarkers of ZL-82 tablets in participants with moderate to severe AD.
Time frame
Day1,Day15,Day29,Day57,Day85,Day113,If necessary, planned external visits to the participants must be conducted.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov