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Atopic DermatitisPhase 1/2NCT05525715

A Study of QY201 Tablet in Subjects With Moderate to Severe Atopic Dermatitis

A Phase 1/2 study of Atopic Dermatitis, run by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atopic Dermatitis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
260 participants
Where
No sites listed yet
Study dates
Oct 2022to Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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;
  • Part 2 (Phase Ⅱ):
  • Fasting blood glucose poorly controlled>10 mmol/L;Hypertension poorly controlled by medication (Systolic pressure≥160mmHg, Diastolic pressure≥100mmHg);WBC<3.0×109/L, Neutrophils<1.5×109/L; Lymphocyte count<0.8×109/L, Platelet count<100.0×109/L and Hemoglobin<100 g/L;Serum creatinine>1.5 times the ULN or eGFR<40 mL/min;Total bilirubin>1.5 times the ULN, AST or ALT values>2 times the ULN;PT or APTT values>1.5 times the ULN.
  • Have a clinical symptomatic infection requiring antimicrobial therapy, such as bacteria, viruses, parasites or fungi during screening.
  • Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode ) of localized, dermatomal herpes zoster.
  • Have a history of cerebral hemorrhage or cerebral infarction within 1 years prior to Day 1.
  • Have a history of alcohol or substance abuse within 6 months prior to Day 1.
  • Have a history of hemorrhage (more than 400 mL), such as trauma, blood collection or donation, or have a plan of blood donation during or after the study.
  • Have been treated by JAK inhibitors, such as Ruxolitinib, Tofacitinib, Baricitinib, Filgotinib, Lestaurtinib, Pacritinib, Delgocitinib, Upadacitinib, or Abrocitinib, within 3 months prior to Day 1.
  • Have been treated by biologicals of AD, such as Dupilumab, within 8 weeks or 5 half-live prior to Day 1, whichever is longer.
  • Have received grade 3 or 4 surgery within 8 weeks prior to Day 1.
  • Have been vaccinated with live or attenuated live vaccine within 4 weeks prior to Day 1.
  • Prior to Day 1, have joined any clinical trial of drug within 4 weeks (or 5 half-life periods, depending on the longer one), or any clinical trial of medical apparatus and instruments within 3 months.
  • Have been treated by any long-acting anticoagulant drugs, such as Warfarin, Clopidogrel, or subjects who require continuous anticoagulant therapy, except for Aspirin≤100 mg per day.
  • Have a history of oral immune suppressants (eg, systemic corticosteroids, cyclosporine A [CsA], mycophenolate-mofetil [MMF], interferon-γ [IFN-γ], azathioprine, methotrexate) or Phototherapy (eg, UVB or PUVA) within 4 weeks or within 5 half-lives (if known) prior to Day 1, whichever is longer.
  • Have received topical treatments that could affect atopic dermatitis (eg, corticosteroids (TCS), calcineurin inhibitors (TCI), or PDE-4 inhibitors) within 2 weeks prior to Day 1.
  • Have received strong inhibitors or inducers of CYP3A Hepatic metabolic enzymes.
  • Subjects who are unable to take tablets, allergic to the active ingredient or excipient of the investigational drug.
  • In the opinion of the investigator, subjects have a history of gastrointestinal diseases that will affect the absorption of oral drugs, such as gastrointestinal perforation.
  • Pregnant female subjects, breastfeeding female subjects, or male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 6 months after last use of investigational drug.
  • Subjects who are unavoidable to or plan exposure to natural or artificial ultraviolet (UV) radiation which could affect atopic dermatitis in the opinion of the investigator.
  • In the opinion of the investigator, subjects who are not suitable to participate in this clinical study.

Trial locations and contacts

No sites are listed yet.

LiMing Wu, Ph.D, M.D contact

0571- 56007501

18957118053@163.com

About this study

Official title: 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

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

Being tested
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
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2mg QY201 tablets or 2mg QY201 placebo,BIDDrug

    2mg QY201 tablets or 2mg QY201 placebo,BID

  • 5mg QY201 tablets or 5mg QY201 placebo,BIDDrug

    5mg QY201 tablets or 5mg QY201 placebo,BID

  • 10mg QY201 tablets or 10mg QY201 placebo,QDDrug

    10mg QY201 tablets or 10mg QY201 placebo,QD

  • 10mg QY201 tablets or 10mg QY201 placebo,BIDDrug

    10mg QY201 tablets or 10mg QY201 placebo,BID

  • 15mg QY201 tablets or 15mg QY201 placebo,BIDDrug

    15mg QY201 tablets or 15mg QY201 placebo,BID

  • 20mg QY201 tablets or 20mg QY201 placebo,BIDDrug

    20mg QY201 tablets or 20mg QY201 placebo,BID

  • 5mg QY201 tablets，BIDDrug

    5mg QY201 tablets，BID

  • 10mg QY201 tablets，BIDDrug

    10mg QY201 tablets，BID

  • 20mg QY201 tablets，BIDDrug

    20mg QY201 tablets，BID

  • QY201 placebo，BIDDrug

    QY201placebo，BID

Study groups in NCT05525715
Study groupRoleWhat they receive
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
Receives: Drug: 2mg QY201 tablets or 2mg QY201 placebo,BID
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
Receives: Drug: 5mg QY201 tablets or 5mg QY201 placebo,BID
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
Receives: Drug: 10mg QY201 tablets or 10mg QY201 placebo,QD
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
Receives: Drug: 10mg QY201 tablets or 10mg QY201 placebo,BID
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
Receives: Drug: 15mg QY201 tablets or 15mg QY201 placebo,BID
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
Receives: Drug: 20mg QY201 tablets or 20mg QY201 placebo,BID
Phase II Cohort1 (5mg QY201 tablets)Experimental50 subjects use 5mg QY201 tablets twice daily for 12 weeks
Receives: Drug: 5mg QY201 tablets，BID
Phase II Cohort2 (10mg QY201 tablets)Experimental50 subjects use 10mg QY201 tablets twice daily for 12 weeks
Receives: Drug: 10mg QY201 tablets，BID
Phase II Cohort3 (20mg QY201 tablets)Experimental50 subjects use 20mg QY201 tablets twice daily for 12 weeks
Receives: Drug: 20mg QY201 tablets，BID
Phase II Cohort4 (QY201 placebo)Experimental50 subjects use QY201 placebo twice daily for 12 weeks
Receives: Drug: QY201 placebo，BID

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From the first administration to 28 days after the last administration of the study drug

  2. 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.

    Measured: Week 12

Secondary outcomes (8)

  1. Pharmacokinetic parameters-Phase Ib

    Tmax

    Measured: Day1 to Day 30

  2. Pharmacokinetic parameters-Phase Ib

    Cmax

    Measured: Day1 to Day 30

  3. Pharmacokinetic parameters-Phase Ib

    t1/2

    Measured: Day1 to Day 30

  4. Pharmacokinetic parameters-Phase Ib

    AUC0-t

    Measured: Day1 to Day 30

  5. Pharmacokinetic parameters-Phase Ib

    CL/F

    Measured: Day1 to Day 30

  6. Pharmacokinetic parameters-Phase Ib

    Vz/F

    Measured: Day1 to Day 30

  7. Percentage of Participants Achieving >=50%/75%/90% Improvement From Baseline in Eczema Area and Severity Index (EASI-50/EASI-75/EASI-90) Response at Week 2 and 4

    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.

    Measured: Week 2 and 4

  8. Number of Participants With Treatment Emergent Adverse Events (AEs)- Phase Ⅱ

    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

    Measured: From the first administration to 28 days after the last administration of the study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2022
  2. Study startOct 2022 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05525715
Sponsor's protocol ID
QY201-Ⅰ-2
Status last verified
Aug 2022
First submitted
28 Aug 2022
Last updated
2 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study of Atopic Dermatitis, run by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact LiMing Wu, Ph.D, M.D (0571- 56007501, 18957118053@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (AEs)- Phase Ⅰb (time frame: From the first administration to 28 days after the last administration of the study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05525715.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.

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