A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis

Last updated: April 23, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2

Condition

Atopic Dermatitis

Hives (Urticaria)

Rosacea

Treatment

Placebo

Lutikizumab

Clinical Study ID

NCT06718101
M24-727
  • Ages > 18
  • All Genders

Study Summary

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to evaluate the clinical efficacy and safety of single therapies and/or combination therapies for moderate to severe AD through multiple substudies.

This study will consist of multiple sub-studies, Sub-Study 1 will have a randomized, placebo controlled period 1 followed by a lutikizumab treatment period 2 enrolling 80 participants at a 1 to 1 ratio.

In Sub-Study 1, participants will receive subcutaneous (SC) injections of lutikizumab or matching placebo every other week for 16 weeks followed by an additional 32 weeks of subcutaneous (SC) injections of lutikizumab every other week for a total of 52 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and biomarker collections.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of AD with onset of symptoms at least 1 year prior to the Baseline Visitand participant meets Hanifin and Rajka criteria.

  • Participant has applied non-medicated, additive-free bland emollient twice daily forat least 7 days before the Baseline Visit.

  • History of inadequate response to topical corticosteroids (TCS), topical calcineurininhibitors (TCI), or topical JAK inhibitors, OR systemic treatment for AD, ORparticipants for whom topical treatments are otherwise medically inadvisable (e.g.,because of important side effects or safety risks).

Exclusion

Exclusion Criteria:

  • Use of the following AD treatments within the specified washout period prior to theBaseline 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] orwithin 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 weeksfor nemolizumab; < 16 weeks for tralokinumab and lebrikizumab.

  • Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure thatcould 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 blandemollients), including but not limited to TCS, TCIs, or topical PDE-4 inhibitorswithin 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 5half-lives [if known] or within 14 days, whichever is longer.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 19, 2024
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Medical Corporation Kojinkai Sapporo Dermatology Clinic /ID# 273619

    Sapporo, Hokkaido 060-0063
    Japan

    Active - Recruiting

  • Tachikawa Dermatology Clinic /ID# 273620

    Tachikawa-shi, Tokyo 190-0023
    Japan

    Active - Recruiting

  • Dermatology Research Associates - Los Angeles /ID# 272945

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • Western States Clinical Res /ID# 271748

    Wheat Ridge, Colorado 80033-2896
    United States

    Active - Recruiting

  • Skin Care Research Boca Raton /ID# 272544

    Boca Raton, Florida 33486-2269
    United States

    Active - Recruiting

  • Research Associates of South Florida /ID# 272549

    Miami, Florida 33134
    United States

    Active - Recruiting

  • Advanced Clinical Research Institute /ID# 272558

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Arlington Dermatology /ID# 271735

    Rolling Meadows, Illinois 60008
    United States

    Active - Recruiting

  • Equity Medical, LLC /ID# 272555

    New York, New York 10023-7340
    United States

    Active - Recruiting

  • Oregon Dermatology & Research Center /ID# 271733

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Clinical Partners /ID# 271791

    Johnston, Rhode Island 02919
    United States

    Active - Recruiting

  • Health Concepts /ID# 271744

    Rapid City, South Dakota 57702
    United States

    Active - Recruiting

  • Orion Clinical Research /ID# 274236

    Austin, Texas 78759
    United States

    Active - Recruiting

  • Center for Clinical Studies - Clear Lake /ID# 271749

    Webster, Texas 77598
    United States

    Active - Recruiting

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