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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 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lutikizumab
Study Locations (20)
Florida
- Skin Care Research Boca Raton /ID# 272544 — Boca Raton
- Research Associates of South Florida /ID# 272549 — Miami
- Advanced Clinical Research Institute /ID# 272558 — Tampa
- Encore Medical Research - Weston /ID# 272539 — Weston
Texas
- Orion Clinical Research /ID# 274236 — Austin
- Complete Dermatology - Sugar Land /ID# 274240 — Sugar Land
- Dermatology Associates of Tyler /ID# 273684 — Tyler
- Center for Clinical Studies - Clear Lake /ID# 271749 — Webster
California
- Dermatology Research Associates - Los Angeles /ID# 272945 — Los Angeles
- Integrative Skin Science and Research /ID# 274243 — Sacramento
- Clinical Trials Research Institute /ID# 274234 — Thousand Oaks
Arizona
- Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550 — Fountain Hills
Colorado
- Western States Clinical Res /ID# 271748 — Wheat Ridge
Illinois
- Arlington Dermatology /ID# 271735 — Rolling Meadows
Nebraska
- Somnos Clinical Research /ID# 272943 — Lincoln
New York
- Equity Medical, LLC /ID# 272555 — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2024-12-19 |
| Est. Completion | 2027-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06718101
The ClinicalTrials.gov registry entry for NCT06718101 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06718101 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06718101 about?
NCT06718101 is a clinical study titled "A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis". 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 ...
What is the current status of trial NCT06718101?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2024-12-19. Estimated completion is 2027-05.
What conditions does trial NCT06718101 study?
This clinical trial studies the following conditions: Atopic Dermatitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06718101?
The interventions under investigation include: Placebo (DRUG), Lutikizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06718101?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06718101 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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