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
- Diseases
- Atopic dermatitis (eczema)
- 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
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal United Hospital /ID# 274328 Coordinator of this site? Confirm its status | Bath | United Kingdom | Unknown status |
| Chapel Allerton Hospital /ID# 274762 Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Royal Liverpool University Hospital /ID# 272584 Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Kyoto University Hospital /ID# 275237 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Medical Corporation Kojinkai Sapporo Dermatology Clinic /ID# 273619 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Tachikawa Dermatology Clinic /ID# 273620 Coordinator of this site? Confirm its status | Tachikawa-shi | Japan | Unknown status |
| Korea University Ansan Hospital /ID# 271786 Coordinator of this site? Confirm its status | Ansan-si | South Korea | Unknown status |
| Soon Chun Hyang University Hospital Bucheon /ID# 271788 Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Unknown status |
| Hallym University Kangnam Sacred Heart Hospital /ID# 271785 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Konkuk University Medical Center /ID# 271789 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital /ID# 271787 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Orion Clinical Research /ID# 274236 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Skin Care Research Boca Raton /ID# 272544 Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550 Coordinator of this site? Confirm its status | Fountain Hills | United States | Unknown status |
| Clinical Partners /ID# 271791 Coordinator of this site? Confirm its status | Johnston | United States | Unknown status |
| Somnos Clinical Research /ID# 272943 Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| Dermatology Research Associates - Los Angeles /ID# 272945 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Research Associates of South Florida /ID# 272549 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Equity Medical /ID# 272555 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Oregon Dermatology and Research Center /ID# 271733 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Health Concepts /ID# 271744 Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
| Arlington Dermatology /ID# 271735 Coordinator of this site? Confirm its status | Rolling Meadows | United States | Unknown status |
| Integrative Skin Science and Research /ID# 274243 Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Complete Dermatology - Sugar Land /ID# 274240 Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Advanced Clinical Research Institute - Tampa /ID# 272558 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Clinical Trials Research Institute /ID# 274234 Coordinator of this site? Confirm its status | Thousand Oaks | United States | Unknown status |
| Dermatology Associates of Tyler /ID# 273684 Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| Center for Clinical Studies - Clear Lake /ID# 271749 Coordinator of this site? Confirm its status | Webster | United States | Unknown status |
| Encore Medical Research - Weston /ID# 272539 Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
| Western States Clinical Res /ID# 271748 Coordinator of this site? Confirm its status | Wheat Ridge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.