Testing LNK01001 for moderate to severe atopic dermatitis
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate LNK01001 in Adults Subjects With Moderate to Severe Atopic Dermatitis.
This study is testing a new treatment called LNK01001 to see if it can help adults with moderate to severe atopic dermatitis feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 354 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Lynk Pharmaceuticals Co., Ltd Industry-sponsored |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT06277245 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blind study designed to evaluate the efficacy and safety of LNK01001 in adults with moderate to severe atopic dermatitis who are candidates for systemic therapy. Participants will undergo a 35-day screening period followed by a 16-week treatment phase where they will be assigned to receive either LNK01001 or a placebo. The study includes a long-term extension period of 36 weeks and a follow-up phase lasting 28 to 35 days. Rescue therapy is permitted under specific conditions if participants do not show adequate improvement.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of atopic dermatitis for at least one year and a documented history of inadequate response to topical treatments.
Not a fit: Patients with other active skin diseases or those currently undergoing prohibited treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from moderate to severe atopic dermatitis.
How similar studies have performed: Other studies have shown promise in treating atopic dermatitis with systemic therapies, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be at least ≥18 and ≤75 years of age. * The subject has a diagnosis of atopic dermatitis for at least 1 year. * Meets the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥4. * Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit. Exclusion Criteria: * Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of investigational product unable or unwilling to discontinue current atopic dermatitis treatments before the study. * Requirement of prohibited medications during the study. * Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions. * History of malignancy or current diagnosis of malignancy before screening visit. In the opinion of the investigator or sponsor, any uncontrolled clinically significant laboratory abnormality that would affect the interpretation of study data or the subject's participation in the study uncontrolled diabetes, hypertension, kidney disease, liver disease, or severe heart disease.
Where this trial is running
Guangzhou
- Dermatological Hospital of Southern Medical University — Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Jianzhong Zhang — Peking University People's Hospital
- Study coordinator: Leo Rao
- Email: xrao1@lynkpharma.com
- Phone: 0086-0571-8771-9103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.