A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Atopic Dermatitis
In brief
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.
Key facts
- Study ID
- NCT06718101
- Run by
- AbbVie
- People needed
- 83
- Starts
- 2024-12-19
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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 it is running
- Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550 — Fountain Hills, Arizona, United States
- Dermatology Research Associates - Los Angeles /ID# 272945 — Los Angeles, California, United States
- Integrative Skin Science and Research /ID# 274243 — Sacramento, California, United States
- Clinical Trials Research Institute /ID# 274234 — Thousand Oaks, California, United States
- Western States Clinical Res /ID# 271748 — Wheat Ridge, Colorado, United States
- Skin Care Research Boca Raton /ID# 272544 — Boca Raton, Florida, United States
- Research Associates of South Florida /ID# 272549 — Miami, Florida, United States
- Advanced Clinical Research Institute - Tampa /ID# 272558 — Tampa, Florida, United States
- Encore Medical Research - Weston /ID# 272539 — Weston, Florida, United States
- Arlington Dermatology /ID# 271735 — Rolling Meadows, Illinois, United States
- Somnos Clinical Research /ID# 272943 — Lincoln, Nebraska, United States
- Equity Medical /ID# 272555 — New York, New York, United States
- Oregon Dermatology and Research Center /ID# 271733 — Portland, Oregon, United States
- Clinical Partners /ID# 271791 — Johnston, Rhode Island, United States
- Health Concepts /ID# 271744 — Rapid City, South Dakota, United States
- Orion Clinical Research /ID# 274236 — Austin, Texas, United States
- Complete Dermatology - Sugar Land /ID# 274240 — Sugar Land, Texas, United States
- Dermatology Associates of Tyler /ID# 273684 — Tyler, Texas, United States
- Center for Clinical Studies - Clear Lake /ID# 271749 — Webster, Texas, United States
- Medical Corporation Kojinkai Sapporo Dermatology Clinic /ID# 273619 — Sapporo, Hokkaido, Japan
- Kyoto University Hospital /ID# 275237 — Kyoto, Kyoto, Japan
- Tachikawa Dermatology Clinic /ID# 273620 — Tachikawa-shi, Tokyo, Japan
- Korea University Ansan Hospital /ID# 271786 — Ansan-si, Gyeonggido, South Korea
- Soon Chun Hyang University Hospital Bucheon /ID# 271788 — Bucheon-si, Gyeonggido, South Korea
- Seoul National University Hospital /ID# 271787 — Seoul, Seoul Teugbyeolsi, South Korea
Full record on ClinicalTrials.gov
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