Testing LNK01001 for moderate to severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tilrekimig for moderate-to-severe eczema in teens and adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.