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Evaluating treatments for moderate to severe atopic dermatitis

A Phase 2 Multicenter Platform Trial of Targeted Immunomodulator Therapies for Moderate to Severe Atopic Dermatitis

PHASE2 · AbbVie · NCT06718101

This study is testing different treatments, including a new injection, to see which ones work best for people with moderate to severe atopic dermatitis.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie (industry)
Drugs / interventionsdupilumab, nemolizumab, tralokinumab, lebrikizumab, ruxolitinib, tofacitinib, baricitinib, upadacitinib, abrocitinib, filgotinib, methotrexate, lutikizumab
Locations21 sites (Fountain Hills, Arizona and 20 other locations)
Trial IDNCT06718101 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness and safety of various treatments, both alone and in combination, for individuals suffering from moderate to severe atopic dermatitis. It includes multiple sub-studies, with the first focusing on a randomized, placebo-controlled trial where participants will receive subcutaneous injections of lutikizumab or a placebo over a 52-week period. Participants will undergo regular medical assessments and may experience a higher treatment burden compared to standard care. The goal is to determine the best therapeutic options for managing this chronic skin condition.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with atopic dermatitis who have not responded adequately to standard topical treatments.

Not a fit: Patients who have recently used systemic therapies or biologics for atopic dermatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new and effective treatment options for patients with moderate to severe atopic dermatitis.

How similar studies have performed: Other studies have shown promise with similar therapeutic approaches, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of AD with onset of symptoms at least 1 year prior to the Baseline Visit and participant meets Hanifin and Rajka criteria.
* Participant has applied non-medicated, additive-free bland emollient twice daily for at least 7 days before the Baseline Visit.
* History of inadequate response to topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or topical JAK inhibitors, OR systemic treatment for AD, OR participants for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).

Exclusion Criteria:

* Use of the following AD treatments within the specified washout period prior to the Baseline Visit:

  -- Systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4) inhibitors, IFN-γ, and mycophenolate mofetil within 5 half-lives \[if known\] or within 4 weeks, whichever is longer;

  -- Any biologic treatments, (within 5 half-lives \[if known\]) or within 12 weeks (whichever is longer), or as specified below: \< 8 weeks for dupilumab; \< 12 weeks for nemolizumab; \< 16 weeks for tralokinumab and lebrikizumab.
* Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.
* Herbal treatments (e.g., traditional Chinese medicines) within 4 weeks.
* Topical treatments (with the exception of non-medicated, additive-free bland emollients), including but not limited to TCS, TCIs, or topical PDE-4 inhibitors within 7 days.
* Topical JAK inhibitor within 14 days.
* Systemic JAK inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, upadacitinib, abrocitinib \[PF-04965842\], and filgotinib) within 5 half-lives \[if known\] or within 14 days, whichever is longer.

Where this trial is running

Fountain Hills, Arizona and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Atopic Dermatitis, Lutikizumab, ABT-981

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.