A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis (NCT06718101)
A Phase 2 Multicenter Platform Trial of Targeted Immunomodulator Therapies for Moderate to Severe Atopic Dermatitis
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550 โ Fountain Hills, Arizona
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (30 Sites)
Showing the first 25 of 30 sites.
- Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550 โ Fountain Hills, Arizona
- Dermatology Research Associates - Los Angeles /ID# 272945 โ Los Angeles, California
- Integrative Skin Science and Research /ID# 274243 โ Sacramento, California
- Clinical Trials Research Institute /ID# 274234 โ Thousand Oaks, California
- Western States Clinical Res /ID# 271748 โ Wheat Ridge, Colorado
- Skin Care Research Boca Raton /ID# 272544 โ Boca Raton, Florida
- Research Associates of South Florida /ID# 272549 โ Miami, Florida
- Advanced Clinical Research Institute - Tampa /ID# 272558 โ Tampa, Florida
- Encore Medical Research - Weston /ID# 272539 โ Weston, Florida
- Arlington Dermatology /ID# 271735 โ Rolling Meadows, Illinois
- Somnos Clinical Research /ID# 272943 โ Lincoln, Nebraska
- Equity Medical /ID# 272555 โ New York, New York
- Oregon Dermatology and Research Center /ID# 271733 โ Portland, Oregon
- Clinical Partners /ID# 271791 โ Johnston, Rhode Island
- Health Concepts /ID# 271744 โ Rapid City, South Dakota
- Orion Clinical Research /ID# 274236 โ Austin, Texas
- Complete Dermatology - Sugar Land /ID# 274240 โ Sugar Land, Texas
- Dermatology Associates of Tyler /ID# 273684 โ Tyler, Texas
- Center for Clinical Studies - Clear Lake /ID# 271749 โ Webster, Texas
- Medical Corporation Kojinkai Sapporo Dermatology Clinic /ID# 273619 โ Sapporo, Hokkaido
- Kyoto University Hospital /ID# 275237 โ Kyoto, Kyoto
- Tachikawa Dermatology Clinic /ID# 273620 โ Tachikawa-shi, Tokyo
- Korea University Ansan Hospital /ID# 271786 โ Ansan-si, Gyeonggido
- Soon Chun Hyang University Hospital Bucheon /ID# 271788 โ Bucheon-si, Gyeonggido
- Seoul National University Hospital /ID# 271787 โ Seoul, Seoul Teugbyeolsi
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Atopic Dermatitis
- A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden โ Birmingham, Alabama
- ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis โ Phoenix, Arizona
- A Study of Barzolvolimab in Patients With Atopic Dermatitis โ Birmingham, Alabama
- Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis โ Chicago, Illinois
- A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis โ Birmingham, Alabama
- A Study Evaluating APG777 in Atopic Dermatitis โ Fountain Valley, California
Explore by condition: All Atopic Dermatitis clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.