A Phase III Clinical Study of QY201 Tablet in Subjects With Moderate to Severe Atopic Dermatitis.

NCT07180511 | Enrolling By Invitation Phase 3 DMC

• 1 other identifier: QY201-301
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of QY201 tablets in the treatment of adult patients with moderate to severe atopic dermatitis (AD).

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (2)

• The proportion of subjects who achieved EASI-75 at week 16 of treatment.

  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.

  At week 16 of treatment

Study Arms (3)

QY201 placebo tablet

PLACEBO COMPARATOR

Using QY201placebo tablet twice daily for 16 weeks

Drug: 10mg QY201 Placebo tablet; Drug: 20mg QY201 Placebo tablet

20mg QY201 tablet

EXPERIMENTAL

Using 20mg QY201 tablet twice daily for 52 weeks

Drug: 10mg QY201 Placebo tablet; Drug: 20mg QY201 tablet

10mg QY201 tablet

EXPERIMENTAL

Using 10mg QY201 tablet twice daily for 52 weeks

Drug: 20mg QY201 Placebo tablet; Drug: 10mg QY201 tablet

Interventions

10mg QY201 Placebo tablet DRUG

10mg QY201 Placebo tablet

20mg QY201 tablet; QY201 placebo tablet

20mg QY201 Placebo tablet DRUG

20mg QY201 Placebo tablet

10mg QY201 tablet; QY201 placebo tablet

10mg QY201 tablet DRUG

10mg QY201 tablet

10mg QY201 tablet

20mg QY201 tablet DRUG

20mg QY201 tablet

20mg QY201 tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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).

You may not qualify if:

• 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):
• 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;

Sponsors & Collaborators

• E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.: lead

Study Sites (1)

EnitiateBioPharma

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 18, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): May 18, 2027
• Study Completion (Estimated): July 19, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

CN (1)