A Study of QY201 Tablet in Subjects With Moderate to Severe Atopic Dermatitis
A Study of Phase Ⅰb/II to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of QY201 Tablet in Subjects With Moderate to Severe Atopic Dermatitis
1 other identifier
interventional
260
0 countries
N/A
Brief Summary
This is a phase Ib/II, randomized, double-blind, placebo-controlled, parallel, multicenter study of a certain phase to evaluate the efficacy, safety, and pharmacokinetic characteristics of QY201 tablet in subjects in moderate to severe atopic dermatitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2022
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2022
CompletedFirst Posted
Study publicly available on registry
September 2, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedSeptember 2, 2022
August 1, 2022
3.2 years
August 28, 2022
August 30, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Treatment Emergent Adverse Events (AEs)- Phase Ⅰb
Number of participants with treatment emergent adverse events (AEs) and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), physical examination, ECG parameters, clinical laboratory
From the first administration to 28 days after the last administration of the study drug
Percentage of Participants Achieving >=75% Improvement From Baseline in Eczema Area and Severity Index (EASI75) Response at Week 12- Phase Ⅱ
EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs ) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (0 to 9%), 2 (10 to 29%), 3 (30 to 49%), 4 (50 to 69%), 5 (70 to 89%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.
Week 12
Secondary Outcomes (8)
Pharmacokinetic parameters-Phase Ib
Day1 to Day 30
Pharmacokinetic parameters-Phase Ib
Day1 to Day 30
Pharmacokinetic parameters-Phase Ib
Day1 to Day 30
Pharmacokinetic parameters-Phase Ib
Day1 to Day 30
Pharmacokinetic parameters-Phase Ib
Day1 to Day 30
- +3 more secondary outcomes
Study Arms (10)
Phase Ib Cohort 1（2mg QY201 tablets or 2mg QY201 placebo）
EXPERIMENTAL8 subjects use 2mg QY201 tablets，2 subject uses 2mg QY201 placebo ，BID，29 days
Phase Ib Cohort 2（5mg QY201 tablets or 5mg QY201 placebo）
EXPERIMENTAL8 subjects use 5mg QY201 tablets，2 subject uses 5mg QY201 placebo ，BID，29 days
Phase Ib Cohort 3（10mg QY201 tablets or 10mg QY201 placebo）
EXPERIMENTAL8 subjects use 10mg QY201 tablets，2 subject uses 10mg QY201 placebo，QD，29 days
Phase Ib Cohort 4（10mg QY201 tablets or 10mg QY201 placebo）
EXPERIMENTAL8 subjects use 10mg QY201 tablets，2 subject uses 10mg QY201 placebo，BID，29 days
Phase Ib Cohort 5（15mg QY201 tablets or 15mg QY201 placebo）
EXPERIMENTAL8 subjects use 15mg QY201 tablets，2 subject uses 15mg QY201 placebo，BID，29 days
Phase Ib Cohort 6（20mg QY201 tablets or 20mg QY201 placebo）
EXPERIMENTAL8 subjects use 20mg QY201 tablets，2 subject uses 20mg QY201 placebo，BID，29 days
Phase II Cohort1 (5mg QY201 tablets)
EXPERIMENTAL50 subjects use 5mg QY201 tablets twice daily for 12 weeks
Phase II Cohort2 (10mg QY201 tablets)
EXPERIMENTAL50 subjects use 10mg QY201 tablets twice daily for 12 weeks
Phase II Cohort3 (20mg QY201 tablets)
EXPERIMENTAL50 subjects use 20mg QY201 tablets twice daily for 12 weeks
Phase II Cohort4 (QY201 placebo)
EXPERIMENTAL50 subjects use QY201 placebo twice daily for 12 weeks
Interventions
2mg QY201 tablets or 2mg QY201 placebo,BID
5mg QY201 tablets or 5mg QY201 placebo,BID
10mg QY201 tablets or 10mg QY201 placebo,QD
10mg QY201 tablets or 10mg QY201 placebo,BID
15mg QY201 tablets or 15mg QY201 placebo,BID
20mg QY201 tablets or 20mg QY201 placebo,BID
Eligibility Criteria
You may qualify if:
- Having been informed the purpose, nature, methods and possible adverse reactions of the trial, the subjects agreed to be subjects and sign an informed consent form before the start of any research process.
- Part1（Phase Ⅰb）：Male and female subjects aged 18 to 65 (including 18 and 45).Part2（Phase Ⅱ）：Male and female subjects aged 18 to 75 (including 18 and 45).
- Atopic dermatitis with a diagnosis confirmed by a dermatologist (according to the Hanifin and Rajka criteria); and also onset of symptoms at least 6 month prior to screening visit.
- Moderate to severe atopic dermatitis defined by an IGA score ≥ 3，an EASI ≥ 16, an PP-NRS≥4, and an BSA ≥ 10% at the screening and baseline visit.
- Documented history (within 6 mouths prior to the screening visit) of inadequate or medically inadvisable response to topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), systematic treatment or phototherapy.
- Twice daily use of an stable-dose, additive-free, bland emollient for at least 7 days prior to Day 1, and continued for the duration of this trial.
- Communicate well with investigators, understand and abide by requirements of this trial.
You may not qualify if:
- Have evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (TB) as defined by investigators or specialist physicians according to history, symptoms, signs, laboratory tests, T-SPOT test,and imagings, unless subjects had previously received an adequate course of therapy at least 1 month.
- History of mental disorders, genetic history of mental disorder, or epilepsy treated by antipsychotics and sedatives.
- In addition to AD, subjects who have current or recent history of clinically significant severe immunologic/rheumatologic, cardiovascular, hepatic, renal, gastrointestinal, or neurologic disease, or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ that might need systematic hormone therapy or other interventions, may increase the risk defined by investigators.
- In addition to AD, subjects have other dermatoses that affect the evaluation of trial results, or have a wide range of tattoos, birthmarks, skin scars in the skin lesion area.
- Have a known immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
- Subjects who have received or are planning to receive an organ transplant operation and are taking immunosuppressants, such as liver or kidney transplantation.
- Any of the following abnormalities:
- Within 3 months, subjects who have acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, or coronary stent implantation prior to Day 1;
- Have a history of severe arrhythmias, such as (Grade II type 2 or III ATV block, long QT syndrome, or QTcF abnormalities: \>470 ms in men and \>480 ms in women);
- Decompensated cardiac insufficiency (NYHA Class III or IV);
- Other cardiac conditions that required treatment and are ineligible for the study according to the investigator.
- Infected with various viruses. For Hepatitis B, subjects who are Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) positive, and HBV-DNA positive are not eligible for the study. For hepatitis C, subjects who are HCV antibody positive is excluded. Subjects who are Human Immunodeficiency Viruses antibody or Treponema pallidum antibody positive are also not eligible for the study.
- Presence of any of the following laboratory abnormalities at the screening visit:
- Part 1 (Phase Ⅰb):
- Fasting blood glucose\>Upper limit of normal (ULN);Hypertension poorly controlled by medication (Systolic pressure≥150mmHg, Diastolic pressure≥95mmHg);WBC, Neutrophils, Lymphocyte count, Platelet count or Hemoglobin\<lower limits of normal (LLN);Serum creatinine\>ULN or eGFR\<60 mL/min;Total bilirubin, AST or ALT values\>ULN;PT or APTT values\>ULN;
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
LiMing Wu, Ph.D, M.D
Affiliated Hangzhou First People's Hospital of Zhejiang University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2022
First Posted
September 2, 2022
Study Start
October 1, 2022
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
September 2, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share