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New treatment option for Atopic Dermatitis
Official title A Phase II Clinical Study Evaluating of ZL-82 Tablets in Atopic Dermatitis
ClinicalTrials.gov ID: NCT07193589
What this study is testing
What is The high-dose group of ZL-82 tablets?
The high-dose group of ZL-82 tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for atopic dermatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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)...
- 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...
- IGA score of 3 or 4;
- EASI score \>= 16;
You likely can't join if
- Allergy to the test drug or any component thereof, or allergy or intolerance to other oral Janus kinase (JAK) inhibitors.
- Use of any of the following drugs or treatments: a. Within 1 month before the baseline, received other oral JAK inhibitor treatment, or had a lack of...
- Individuals with a history of major diseases: This includes but is not limited to those with a history of diseases in the digestive system...
- Family Planning: a. Pregnant or lactating women; b. Throughout the entire study period, all participants or their spouses (or partners) who have...
- Those who have a history of malignant tumors in the past, including solid tumors and hematological malignancies (excluding basal cell carcinoma and...
- Those who have undergone major surgical procedures within 4 weeks before screening or are scheduled to undergo such procedures during the screening...
See the full eligibility criteria
- 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...
- IGA score of 3 or 4;
- EASI score \>= 16;
- Average peak pruritus NRS score \>= 4 in the past week (Note: The NRS average value is the average of the maximum NRS score of pruritus intensity over 7 consecutive days before baseline, with a score range of 0-10 for...
- BSA (body surface area) affected by AD \>= 10% (BSA: body surface area, in this trial, BSA is based on the average human body surface area of 1.6 m2); 5. Participants who have been treated with local corticosteroid...
- Allergy to the test drug or any component thereof, or allergy or intolerance to other oral Janus kinase (JAK) inhibitors.
- Use of any of the following drugs or treatments: a. Within 1 month before the baseline, received other oral JAK inhibitor treatment, or had a lack of how well it works or intolerance to other oral 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...
- 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...
- 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).
- Those who have undergone major surgical procedures within 4 weeks before screening or are scheduled to undergo such procedures during the screening period.
- Those whose hepatitis B surface antigen or hepatitis B core antibody (except for HBV DNA results within the normal range) is positive, hepatitis C antibody (except for HCV RNA results within the normal range) is...
- Participants should have resting systolic blood pressure (SBP) \ = 160 mmHg, DBP \>= 100 mmHg) treated with two or more antihypertensive drugs but with poor control, and those with severe sleep apnea and other diseases...
- 12-lead ECG before screening and before the first administration suggests that the PR interval \> 200 msec, heart rate \ = 450 ms (for males), and \>= 470 ms for females. 10. Participants with a history of severe...
- Total bilirubin \> 1.5 × upper limit of normal (ULN);
- AST \> 1.5 × ULN;
- ALT \> 1.5 × ULN. 23. With moderate or end-stage renal function impairment, including but not limited to: a. Estimated glomerular filtration rate \ 1.4 mg/dL or 123 μmol/L (for female participants); d. Creatinine level...
- Within 12 weeks before the first administration of the investigational drug:
- Intravenous immunoglobulin or plasma exchange therapy;
- Drugs known to have an impact on the cardiac conduction system (such as Class I or III anti-arrhythmic drugs);
- Other biologics except dupilumab.
- Within 4 weeks before administration, those who have used long-acting anticoagulant drugs (such as warfarin, dabigatran, etc.) or those who need continuous anticoagulant drug treatment (except aspirin \<= 100 mg/day).
- Within 1 week before the first administration of the investigational drug. 1) Use antiplatelet drugs. Note: Based on the investigator's judgment, low-dose aspirin (dose \ = 400 mL (including trauma, blood collection...
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.