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: February 20, 2026
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

2

Condition

Atopic Dermatitis

Dermatitis, Atopic

Allergy

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: 83
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

    Site Not Available

  • Medical Corporation Kojinkai Sapporo Dermatology Clinic /ID# 273619

    Sapporo-shi, Hokkaido 060-0063
    Japan

    Site Not Available

  • Medical Corporation Kojinkai Sapporo Dermatology Clinic /ID# 273619

    Sapporo 2128295, Hokkaido 2130037 060-0063
    Japan

    Site Not Available

  • Kyoto University Hospital /ID# 275237

    Kyoto 1857910, Kyoto 1857907 606-8507
    Japan

    Site Not Available

  • Tachikawa Dermatology Clinic /ID# 273620

    Tachikawa-shi, Tokyo 1850144 190-0023
    Japan

    Site Not Available

  • Korea University Ansan Hospital /ID# 271786

    Ansan-si, Gyeonggido 15355
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital Bucheon /ID# 271788

    Bucheon-si, Gyeonggido 14584
    Korea, Republic of

    Site Not Available

  • Hallym University Kangnam Sacred Heart Hospital /ID# 271785

    Seoul, Seoul Teugbyeolsi 07441
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital /ID# 271787

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • Korea University Ansan Hospital /ID# 271786

    Ansan-si 1846918, Gyeonggido 15355
    South Korea

    Site Not Available

  • Soon Chun Hyang University Hospital Bucheon /ID# 271788

    Bucheon-si 1838716, Gyeonggido 14584
    South Korea

    Site Not Available

  • Hallym University Kangnam Sacred Heart Hospital /ID# 271785

    Seoul 1835848, Seoul Teugbyeolsi 07441
    South Korea

    Site Not Available

  • Konkuk University Medical Center /ID# 271789

    Seoul 1835848, Seoul Teugbyeolsi 05030
    South Korea

    Site Not Available

  • Seoul National University Hospital /ID# 271787

    Seoul 1835848, Seoul Teugbyeolsi 03080
    South Korea

    Site Not Available

  • Royal United Hospital /ID# 274328

    Bath 2656173, Bath And North East Somerset BA1 3NG
    United Kingdom

    Site Not Available

  • Chapel Allerton Hospital /ID# 274762

    Leeds 2644688, West Yorkshire LS7 4SA
    United Kingdom

    Site Not Available

  • Liverpool University Hospitals Nhs Foundation Trust /ID# 272584

    Liverpool 2644210, L7 8XP
    United Kingdom

    Active - Recruiting

  • Royal Liverpool University Hospital /ID# 272584

    Liverpool 2644210, L7 8XP
    United Kingdom

    Site Not Available

  • Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550

    Fountain Hills, Arizona 85268
    United States

    Site Not Available

  • Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550

    Fountain Hills 5295177, Arizona 5551752 85268
    United States

    Site Not Available

  • Dermatology Research Associates - Los Angeles /ID# 272945

    Los Angeles, California 90045
    United States

    Site Not Available

  • Integrative Skin Science and Research /ID# 274243

    Sacramento, California 95815
    United States

    Site Not Available

  • Clinical Trials Research Institute /ID# 274234

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Dermatology Research Associates - Los Angeles /ID# 272945

    Los Angeles 5368361, California 5332921 90045
    United States

    Site Not Available

  • Integrative Skin Science and Research /ID# 274243

    Sacramento 5389489, California 5332921 95815
    United States

    Site Not Available

  • Clinical Trials Research Institute /ID# 274234

    Thousand Oaks 5402405, California 5332921 91320
    United States

    Site Not Available

  • Western States Clinical Res /ID# 271748

    Wheat Ridge, Colorado 80033-2896
    United States

    Site Not Available

  • Western States Clinical Res /ID# 271748

    Wheat Ridge 5443948, Colorado 5417618 80033-2896
    United States

    Site Not Available

  • Skin Care Research Boca Raton /ID# 272544

    Boca Raton, Florida 33486-2269
    United States

    Site Not Available

  • Research Associates of South Florida /ID# 272549

    Miami, Florida 33134
    United States

    Site Not Available

  • Advanced Clinical Research Institute /ID# 272558

    Tampa, Florida 33607
    United States

    Site Not Available

  • Encore Medical Research - Weston /ID# 272539

    Weston, Florida 33331
    United States

    Site Not Available

  • Skin Care Research Boca Raton /ID# 272544

    Boca Raton 4148411, Florida 4155751 33486-2269
    United States

    Site Not Available

  • Research Associates of South Florida /ID# 272549

    Miami 4164138, Florida 4155751 33134
    United States

    Site Not Available

  • Advanced Clinical Research Institute /ID# 272558

    Tampa 4174757, Florida 4155751 33607
    United States

    Site Not Available

  • Encore Medical Research - Weston /ID# 272539

    Weston 4178003, Florida 4155751 33331
    United States

    Site Not Available

  • Arlington Dermatology /ID# 271735

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Arlington Dermatology /ID# 271735

    Rolling Meadows 4908052, Illinois 4896861 60008
    United States

    Site Not Available

  • Somnos Clinical Research /ID# 272943

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Somnos Clinical Research /ID# 272943

    Lincoln 5072006, Nebraska 5073708 68510
    United States

    Site Not Available

  • Equity Medical, LLC /ID# 272555

    New York, New York 10023-7340
    United States

    Site Not Available

  • Equity Medical, LLC /ID# 272555

    New York 5128581, New York 5128638 10023-7340
    United States

    Site Not Available

  • Oregon Dermatology & Research Center /ID# 271733

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Dermatology & Research Center /ID# 271733

    Portland 5746545, Oregon 5744337 97210
    United States

    Site Not Available

  • Clinical Partners /ID# 271791

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Clinical Partners /ID# 271791

    Johnston 8604682, Rhode Island 5224323 02919
    United States

    Site Not Available

  • Health Concepts /ID# 271744

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Health Concepts /ID# 271744

    Rapid City 5768233, South Dakota 5769223 57702
    United States

    Site Not Available

  • Orion Clinical Research /ID# 274236

    Austin, Texas 78759
    United States

    Site Not Available

  • Complete Dermatology - Sugar Land /ID# 274240

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Dermatology Associates of Tyler /ID# 273684

    Tyler, Texas 75703
    United States

    Site Not Available

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

    Webster, Texas 77598
    United States

    Site Not Available

  • Orion Clinical Research /ID# 274236

    Austin 4671654, Texas 4736286 78759
    United States

    Site Not Available

  • Complete Dermatology - Sugar Land /ID# 274240

    Sugar Land 4734825, Texas 4736286 77479
    United States

    Site Not Available

  • Dermatology Associates of Tyler /ID# 273684

    Tyler 4738214, Texas 4736286 75703
    United States

    Site Not Available

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

    Webster 4740423, Texas 4736286 77598
    United States

    Site Not Available

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