Adolescent Participants With Moderate to Severe Atopic Dermatitis (AD)Phase 2NCT07712536
Phase IIa Study of Pharmacokinetics, Safety and Efficacy of QY201 Tablets in Adolescent Subjects With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing QY201 Tablets（10mg） and QY201 Tablets（20mg） in people with Adolescent Participants With Moderate to Severe Atopic Dermatitis (AD), run by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.
Trial summary
To evaluate the population pharmacokinetic characteristics of QY201 Tablets in adolescent participants with moderate to severe atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Adolescent Participants With Moderate to Severe Atopic Dermatitis (AD)
- What is being tested?
- QY201 Tablets（10mg） and QY201 Tablets（20mg）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2025to 19 Dec 2025
- Phase
- Phase 2
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The participant and their parent/legal guardian (if applicable) shall have effective communication with the investigator, fully understand the purpose, nature, methods and potential adverse reactions of this trial, comprehend and comply with all requirements of the study, and sign the Informed Consent Form (ICF) prior to initiation of any study procedures.
- Age ≥12 years and <18 years (calculated based on the date of ICF signature), any gender, body weight ≥40 kg.
- Has a documented history of atopic dermatitis (AD) for at least 6 months at screening, and meets the Hanifin-Rajka diagnostic criteria at screening.
- Meets criteria for moderate to severe AD at screening and baseline:
- Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥3 at screening and baseline; Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline; Body Surface Area (BSA) affected by AD ≥10% at screening and baseline; Weekly average of daily Pruritus Numerical Rating Scale (PP-NRS) score ≥4 at baseline.
- Within 6 months prior to screening, documented evidence of inadequate response to or intolerance of topical therapies including topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI); or documented indication for systemic therapy (e.g., systemic corticosteroids, conventional immunosuppressants, biologics, JAK inhibitors, etc.) for disease control.
- The participant is able and willing to regularly apply fragrance-free and inactive-ingredient-free emollients twice daily for at least 7 consecutive days prior to randomization, and continue such application throughout the study period.
- Participants of childbearing potential (females post-menarche, males post-spermarche) must agree to and implement effective contraception from the date of ICF signature through 3 months after the last study drug administration. For female participants of childbearing potential, serum human chorionic gonadotropin (HCG) test shall be negative at screening, and the subject must not be breastfeeding.
Who cannot join
- Receipt of the following therapies within 12 weeks prior to baseline (or 5 half-lives, whichever is longer):
- Small-molecule targeted drugs: Janus kinase (JAK) inhibitors (e.g., Ruxolitinib, Tofacitinib, Baricitinib, Upadacitinib, Abrocitinib), etc.; Macromolecular biologics: e.g., Dupilumab, Spesolimab, etc.
- Receipt of the following systemic therapies within 4 weeks prior to baseline (or 5 half-lives, whichever is longer):
- Systemic immunosuppressants/immunomodulatory agents (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon gamma, azathioprine, methotrexate, etc.); Phototherapy (e.g., ultraviolet B [UVB], psoralen plus ultraviolet A [PUVA], etc.), including indoor tanning; Systemic Chinese herbal medicines or proprietary Chinese medicines; Other systemic medications for the treatment of atopic dermatitis (AD).
- Receipt of the following topical therapies within 2 weeks prior to baseline:
- Topical corticosteroids (TCS); Topical calcineurin inhibitors (TCI); Topical phosphodiesterase 4 (PDE-4) inhibitors; Topical Chinese herbal preparations or herbal medicated baths; Other topical medications for the treatment of AD.
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- Receipt of allergen-specific immunotherapy within 6 months prior to baseline.
- Use of strong inhibitors or strong inducers of cytochrome P450 3A (CYP3A) hepatic metabolic enzymes within 2 weeks prior to baseline.
- Use of long-acting anticoagulants (e.g., warfarin, clopidogrel, etc.) within 4 weeks prior to baseline, or requirement for continuous anticoagulant therapy (excluding aspirin at a dose ≤100 mg per day).
- Planned administration of live or attenuated live vaccines within 4 weeks prior to baseline; or anticipated need for live or attenuated live vaccines during the study period (including at least 4 weeks after the last dose of investigational product).
- Participation in any clinical trial involving an investigational product within 4 weeks prior to baseline (or 5 half-lives, whichever is longer), or participation in any clinical trial involving a medical device within 3 months prior to baseline.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the population pharmacokinetic characteristics of QY201 Tablets in adolescent participants with moderate to severe atopic dermatitis (AD).
- Being tested
- QY201 Tablets（10mg）, QY201 Tablets（20mg）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QY201 Tablets（10mg）Drug
10 mg twice daily for 28 consecutive days
QY201 Tablets（20mg）Drug
20 mg twice daily for 28 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| QY201 Tablets（10mg） | Experimental | 10 mg twice daily for 28 consecutive days Receives: Drug: QY201 Tablets（10mg） |
| QY201 Tablets（20mg） | Experimental | 20 mg twice daily for 28 consecutive days Receives: Drug: QY201 Tablets（20mg） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of QY201 at multiple time points; population pharmacokinetic (PopPK) profiles of QY201
Measured: Day29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
4 Jun 202519 Dec 2025
- First posted17 Jul 2026
- Study start4 Jun 2025
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Participants With Moderate to Severe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
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
- NCT07712536
- Sponsor's protocol ID
- QY201-203
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No