Atopic Dermatitis (AD)Phase 3NCT07180511
A Phase III Clinical Study of QY201 Tablet in Subjects With Moderate to Severe Atopic Dermatitis.
A Phase 3 study testing 10mg QY201 tablet and 20mg QY201 tablet in people with Atopic Dermatitis (AD), run by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy of QY201 tablets in the treatment of adult patients with moderate to severe atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- 10mg QY201 tablet and 20mg QY201 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2025to 19 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- The subject is able to communicate well with the investigator, fully understand the trial's purpose, nature, methods, and potential adverse reactions, voluntarily agrees to participate as a subject, understands and complies with all requirements of the study, and signs the ICF before any study procedures begin;
- At the time of signing the ICF, the subject is between 18 and 75 years of age (inclusive), regardless of gender;
- Has a history of AD for at least 1 year at screening and meets the Hanifin-Rajka diagnostic criteria (see Appendix 1) at screening;
- Meets the criteria for moderate-to-severe AD at both screening and baseline (all 4 criteria must be met):
- vIGA-AD score ≥3 at screening and baseline (see Appendix 2);
- EASI score ≥16 at screening and baseline (see Appendix 3);
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- BSA ≥10% at screening and baseline (see Appendix 4);
- Weekly average of daily PP-NRS score ≥4 at baseline (see Appendix 6); [Note] The weekly average of the daily PP-NRS score at baseline will be calculated based on the scores recorded daily during the 7 consecutive days prior to baseline. If there are fewer than 7 days of daily PP-NRS scores during the 7 consecutive days prior to baseline, scores from at least 4 days must be used for the calculation. If there are fewer than 4 days, randomization should be postponed, but must not exceed the maximum screening period of 35 days.
- Within 6 months prior to screening, there is a documented history indicating an inadequate response or intolerance to topical treatments such as TCS and/or TCI; or a documented history indicating the need for systemic therapy (e.g., systemic corticosteroids, conventional immunosuppressants, biologics, Janus kinase [JAK] inhibitors, etc.) to control the disease; [Note] Inadequate response is defined as failure to achieve disease remission or maintain a low disease activity state despite using mid-potency or potent TCS for at least 4 weeks or superpotent TCS for at least 2 weeks as prescribed, or using TCI for at least 4 weeks. Intolerance is defined as worsening of skin lesions after 1-2 weeks of topical treatment, or the occurrence of discomfort including pain, burning, or uncomfortable sensations following drug use.
- The subject is able and willing to regularly use a mild, additive-free emollient at least twice daily for at least 7 consecutive days prior to randomization and to continue its use throughout the study period.
- The subject (including their partner) agrees to have no pregnancy plans from the time of signing the ICF until 3 months after the last dose and voluntarily adopts effective contraceptive measures ;
- Male subjects: Must agree not to donate sperm during the study and for 3 months after the last study drug administration.
- Female subjects:
- Women of childbearing potential: Must have a negative serum human chorionic gonadotropin (HCG) test during the screening period and must not be breastfeeding.
- Women without childbearing potential: Permanently sterilized (e.g., bilateral oophorectomy, bilateral salpingectomy, hysterectomy) or postmenopausal (defined as cessation of menstruation for at least 12 months with other pathological causes excluded; for women under 60 years old, serum follicle-stimulating hormone [FSH] level >40 IU/L must be confirmed).
Who cannot join
- Have used any of the following drugs/treatments within the specified time frames:
- Previously participated in any clinical trial of QY201 tablets;
- Used the following systemic treatments within 12 weeks before baseline (or 5 half-lives, whichever is longer):
- Small molecule targeted drugs: JAK inhibitors (e.g., Ruxolitinib, Tofacitinib, Baricitinib, Upadacitinib, Abrocitinib), etc.;
- Macromolecular biologics: such as Dupilumab, etc.;
- Used the following systemic treatments within 4 weeks before baseline (or 5 half-lives, whichever is longer):
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- Systemic immunosuppressants/immunomodulatory drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon gamma, azathioprine, methotrexate, etc.);
- Phototherapy (e.g., ultraviolet B [UVB], psoralen + ultraviolet A [PUVA], etc.), including indoor tanning;
- Systemic traditional Chinese herbal medicines or proprietary Chinese medicines that may affect efficacy evaluation;
- Other systemic drugs for treating AD;
- Used topical JAK inhibitors for local treatment within 4 weeks before baseline; used the following local treatments within 1 week before baseline:
- TCS;
- TCI;
- Topical phosphodiesterase-4 (PDE-4) inhibitors;
- Topical traditional Chinese medicine preparations or local herbal baths that may affect efficacy evaluation;
- Other local drugs for treating AD;
- Received allergen-specific immunotherapy within 6 months before baseline;
- Used strong inhibitors or inducers of cytochrome P450 3A enzyme (CYP3A) within 2 weeks before baseline (see Appendix 9);
- Used long-acting anticoagulants (e.g., warfarin, clopidogrel, etc.) within 4 weeks before baseline or required continuous use of anticoagulant therapy (except aspirin ≤100 mg/day);
- Planned to receive live vaccines or live attenuated vaccines within 4 weeks before baseline; or expected to require live vaccines or live attenuated vaccines during the study period (including at least 4 weeks after the last dose of the investigational product);
- Participated in and used any investigational drug within 4 weeks (or 5 half-lives, whichever is longer) before baseline, or participated in and used any medical device in a clinical trial within 3 months;
- Have any of the following medical histories or abnormalities:
- Other skin comorbidities that, in the investigator's assessment, may interfere with the study evaluation, aside from AD;
- History of disseminated herpes zoster (a single episode) or disseminated herpes simplex (a single episode), or recurrent (≥2 episodes) localized herpes zoster;
- Diagnosed or suspected active tuberculosis, latent untreated tuberculosis, or incompletely cured tuberculosis, as judged by the investigator and/or specialist (based on epidemiological history, symptoms, signs, laboratory tests, interferon-gamma release assay, imaging, etc.); unless there is documented evidence of adequate treatment or prophylactic anti-tuberculosis therapy started at least 2 weeks before the investigational product administration (and required to be used until the full course is completed), and the investigator and/or specialist judges that the subject can currently start JAK inhibitor treatment;
- Chronic active infection or acute infection requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, antiprotozoal drugs, or antifungal drugs within 4 weeks before screening; or superficial skin infection requiring treatment within 1 week before screening;
- Known history of invasive infections (histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) (even if the infection has been resolved), or, in the investigator's judgment, abnormally frequent, recurrent, or prolonged infections suggesting possible immunodeficiency, or history of human immunodeficiency virus (HIV) infection;
- Subjects with a history of thromboembolism (including deep vein thrombosis, pulmonary embolism, arterial thrombosis, etc.), or other high-risk populations prone to thromboembolism (the investigator comprehensively judges that such subjects are unsuitable for participation in this study based on clinical assessment);
- Any of the following cardiovascular and cerebrovascular diseases/abnormalities:
- Moderate to severe heart failure (New York Heart Association Class III or IV);
- Previous large-area cerebral infarction/cerebral hemorrhage, myocardial infarction, coronary artery stent implantation;
- Poorly controlled or refractory hypertension (after drug control, systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
- Significant abnormalities on electrocardiogram (ECG), which, in the investigator's judgment, may pose an unacceptable risk to the subject participating in the clinical study, including but not limited to severe arrhythmia, QT interval corrected for heart rate using Fridericia's formula (QTcF) >480 ms;
- Other cardiovascular and cerebrovascular-related medical histories/abnormalities that, in the investigator's judgment, make the subject unsuitable for participation in this study.
- Subjects who have undergone or plan to undergo organ transplant surgery and require immunosuppressants (e.g., liver or kidney transplantation);
- History of gastrointestinal perforation (except appendicitis or penetrating injury) or diverticulitis;
- Conditions that may interfere with drug absorption, including but not limited to short bowel syndrome, gastrectomy, or specific types of bariatric surgery (e.g., gastric bypass surgery);
- History of any malignancy, except successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix;
- History of drug or alcohol abuse within 6 months before screening;
- Other cardiovascular diseases, respiratory diseases, digestive diseases, endocrine diseases, autoimmune diseases, hematological diseases, urinary diseases, neuropsychiatric diseases, etc., that the investigator deems unsuitable for participation in this study;
- Subjects who have undergone major surgery within 8 weeks before baseline or plan to undergo major surgery during the study period;
- Blood loss ≥400 mL (including trauma, blood sampling, blood donation) within 12 weeks before baseline, or plan to donate blood during the study period or within 1 month after the study ends;
- Inability to take oral tablets or allergy to the active ingredient or excipients of the investigational product;
- Have any of the following laboratory abnormalities:
- Laboratory abnormalities during screening and at baseline:
- Blood routine: white blood cells <2.5×10⁹/L, neutrophils <1.5×10⁹/L, lymphocyte count <0.8×10⁹/L; platelet count <100×10⁹/L, hemoglobin <100 g/L;
- Renal function: estimated glomerular filtration rate (eGFR) <40 mL/min/1.73m², calculated using the Modification of Diet in Renal Disease (MDRD) formula;
- Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0× upper limit of normal (ULN) or total bilirubin (TBIL) >1.5×ULN;
- Coagulation function: prothrombin time (PT) or activated partial thromboplastin time (APTT) >1.5×ULN;
- Abnormalities during screening:
- Hepatitis B surface antigen (HBsAg) positive; or hepatitis B core antibody (HBcAb) positive and hepatitis B virus deoxyribonucleic acid (HBV-DNA) positive;
- Hepatitis C virus (HCV) antibody positive and hepatitis C virus ribonucleic acid (HCV-RNA) positive;
- Human immunodeficiency virus (HIV) antibody positive;
- Treponema pallidum antibody positive (except subjects with negative non-treponemal test results and judged by the investigator to have had past syphilis infection that has been cured); [Note] If a subject has abnormal laboratory test results during screening, the investigator may arrange one retest on a different day within the 35-day screening period (no drug intervention for the abnormal laboratory results is allowed before retesting), and the retest results will be used as the basis for determining the subject's eligibility.
- Other:
- Any subject whom the investigator considers unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Parallel, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of QY201 Tablets in Subjects With Moderate to Severe Atopic Dermatitis.
To evaluate the efficacy of QY201 tablets in the treatment of adult patients with moderate to severe atopic dermatitis (AD).
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- 10mg QY201 Placebo tablet, 20mg QY201 Placebo tablet, 10mg QY201 tablet, 20mg QY201 tablet
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10mg QY201 Placebo tabletDrug
10mg QY201 Placebo tablet
20mg QY201 Placebo tabletDrug
20mg QY201 Placebo tablet
10mg QY201 tabletDrug
10mg QY201 tablet
20mg QY201 tabletDrug
20mg QY201 tablet
| Study group | Role | What they receive |
|---|---|---|
| QY201 placebo tablet | Placebo comparator | Using QY201placebo tablet twice daily for 16 weeks Receives: Drug: 10mg QY201 Placebo tablet; Drug: 20mg QY201 Placebo tablet |
| 20mg QY201 tablet | Experimental | Using 20mg QY201 tablet twice daily for 52 weeks Receives: Drug: 10mg QY201 Placebo tablet; Drug: 20mg QY201 tablet |
| 10mg QY201 tablet | Experimental | Using 10mg QY201 tablet twice daily for 52 weeks Receives: Drug: 20mg QY201 Placebo tablet; Drug: 10mg QY201 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who achieved EASI-75 at week 16 of treatment.
Measured: At week 16 of treatment
The proportion of subjects who achieved vIGA-AD 0/1 with a reduction of ≥2 points from baseline at week 16 of treatment.
Measured: At week 16 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start12 Mar 2025
- Primary completion18 May 2027 (estimated)
- Study completion19 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180511
- Sponsor's protocol ID
- QY201-301
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of QY201 Tablets in Subjects With Moderate to Severe Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT07180511
- Acronym / sponsor ID
- QY201-301
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 18 May 2027 (estimated)
- Study completion
- 19 Jul 2027 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of QY201 tablets in the treatment of adult patients with moderate to severe atopic dermatitis (AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QY201 placebo tablet | Placebo comparator | Drug: 10mg QY201 Placebo tablet, Drug: 20mg QY201 Placebo tabletUsing QY201placebo tablet twice daily for 16 weeks |
| 20mg QY201 tablet | Experimental | Drug: 10mg QY201 Placebo tablet, Drug: 20mg QY201 tabletUsing 20mg QY201 tablet twice daily for 52 weeks |
| 10mg QY201 tablet | Experimental | Drug: 20mg QY201 Placebo tablet, Drug: 10mg QY201 tabletUsing 10mg QY201 tablet twice daily for 52 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The subject is able to communicate well with the investigator, fully understand the trial's purpose, nature, methods, and potential adverse reactions, voluntarily agrees to participate as a subject, understands and complies with all requirements of the study, and signs the ICF before any study procedures begin;
- At the time of signing the ICF, the subject is between 18 and 75 years of age (inclusive), regardless of gender;
- Has a history of AD for at least 1 year at screening and meets the Hanifin-Rajka diagnostic criteria (see Appendix 1) at screening;
- Meets the criteria for moderate-to-severe AD at both screening and baseline (all 4 criteria must be met):
- Within 6 months prior to screening, there is a documented history indicating an inadequate response or intolerance to topical treatments such as TCS and/or TCI; or a documented history indicating the need for systemic therapy (e.g., systemic corticosteroids, conventional immunosuppressants, biologics, Janus kinase [JAK] inhibitors, etc.) to control the disease; [Note] Inadequate response is defined as failure to achieve disease remission or maintain a low disease activity state despite using mid-potency or potent TCS for at least 4 weeks or superpotent TCS for at least 2 weeks as prescribed, or using TCI for at least 4 weeks. Intolerance is defined as worsening of skin lesions after 1-2 weeks of topical treatment, or the occurrence of discomfort including pain, burning, or uncomfortable sensations following drug use.
Key exclusion criteria (56 listed)
- Previously participated in any clinical trial of QY201 tablets;
- Used the following systemic treatments within 12 weeks before baseline (or 5 half-lives, whichever is longer):
- Used the following systemic treatments within 4 weeks before baseline (or 5 half-lives, whichever is longer):
- Used topical JAK inhibitors for local treatment within 4 weeks before baseline; used the following local treatments within 1 week before baseline:
- Received allergen-specific immunotherapy within 6 months before baseline;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10mg QY201 Placebo tablet10mg QY201 Placebo tablet | Drug | 20mg QY201 tablet, QY201 placebo tablet |
| 20mg QY201 Placebo tablet20mg QY201 Placebo tablet | Drug | 10mg QY201 tablet, QY201 placebo tablet |
| 10mg QY201 tablet10mg QY201 tablet | Drug | 10mg QY201 tablet |
| 20mg QY201 tablet20mg QY201 tablet | Drug | 20mg QY201 tablet |
Primary outcome
The proportion of subjects who achieved EASI-75 at week 16 of treatment.
Time frame: At week 16 of treatment
The proportion of subjects who achieved vIGA-AD 0/1 with a reduction of ≥2 points from baseline at week 16 of treatment.
Time frame: At week 16 of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10mg QY201 tablet and 20mg QY201 tablet in people with Atopic Dermatitis (AD), run by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.
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 15 inclusion and 56 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: enrolling by invitation, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects who achieved EASI-75 at week 16 of treatment. (time frame: At week 16 of treatment). 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?
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 18 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.