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NCT06718101Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 14 Aug 2026

Brief summary (registry, in English)

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 substudies. Substudy 1 will have a randomized, open-label period 1 followed by a lutikizumab treatment period 2 enrolling 80 participants at a 1 to 1 ratio. In Substudy 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 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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
83 (actual)
First submitted
2 Dec 2024
Start date
19 Dec 2024
Primary completion date
May 2027
Lead sponsor
AbbVie
NCT number
NCT06718101

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 83
  • From 19 Dec 2024 to the primary completion date, May 2027
  • 30 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.

Other

  • Herbal treatments (e.g., traditional Chinese medicines) within 4 weeks.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal United Hospital /ID# 274328
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BathUnited KingdomUnknown status
Chapel Allerton Hospital /ID# 274762
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LeedsUnited KingdomUnknown status
Royal Liverpool University Hospital /ID# 272584
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LiverpoolUnited KingdomUnknown status
Kyoto University Hospital /ID# 275237
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KyotoJapanUnknown status
Medical Corporation Kojinkai Sapporo Dermatology Clinic /ID# 273619
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SapporoJapanUnknown status
Tachikawa Dermatology Clinic /ID# 273620
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Tachikawa-shiJapanUnknown status
Korea University Ansan Hospital /ID# 271786
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Ansan-siSouth KoreaUnknown status
Soon Chun Hyang University Hospital Bucheon /ID# 271788
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Bucheon-siSouth KoreaUnknown status
Hallym University Kangnam Sacred Heart Hospital /ID# 271785
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SeoulSouth KoreaUnknown status
Konkuk University Medical Center /ID# 271789
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SeoulSouth KoreaUnknown status
Seoul National University Hospital /ID# 271787
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SeoulSouth KoreaUnknown status
Orion Clinical Research /ID# 274236
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AustinUnited StatesUnknown status
Skin Care Research Boca Raton /ID# 272544
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Boca RatonUnited StatesUnknown status
Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550
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Fountain HillsUnited StatesUnknown status
Clinical Partners /ID# 271791
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JohnstonUnited StatesUnknown status
Somnos Clinical Research /ID# 272943
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LincolnUnited StatesUnknown status
Dermatology Research Associates - Los Angeles /ID# 272945
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Los AngelesUnited StatesUnknown status
Research Associates of South Florida /ID# 272549
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MiamiUnited StatesUnknown status
Equity Medical /ID# 272555
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New YorkUnited StatesUnknown status
Oregon Dermatology and Research Center /ID# 271733
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PortlandUnited StatesUnknown status
Health Concepts /ID# 271744
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Rapid CityUnited StatesUnknown status
Arlington Dermatology /ID# 271735
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Rolling MeadowsUnited StatesUnknown status
Integrative Skin Science and Research /ID# 274243
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SacramentoUnited StatesUnknown status
Complete Dermatology - Sugar Land /ID# 274240
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Sugar LandUnited StatesUnknown status
Advanced Clinical Research Institute - Tampa /ID# 272558
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TampaUnited StatesUnknown status
Clinical Trials Research Institute /ID# 274234
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Thousand OaksUnited StatesUnknown status
Dermatology Associates of Tyler /ID# 273684
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TylerUnited StatesUnknown status
Center for Clinical Studies - Clear Lake /ID# 271749
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WebsterUnited StatesUnknown status
Encore Medical Research - Weston /ID# 272539
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WestonUnited StatesUnknown status
Western States Clinical Res /ID# 271748
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Wheat RidgeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.