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 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: M24-727
• Study Type: interventional
• Target: 83
• Locations: 4 countries
• Sites: 30

Brief 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

Atopic Dermatitis

Keywords

Lutikizumab, ABT-981

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16

  EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

  At Week 16

• Percentage of Participants Who Reported Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

  Up to Week 52

Secondary Outcomes (13)

• Percentage of Participants Achieving an Improvement (Reduction) of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS)

  At Week 4

• Percentage of Participants Achieving an EASI 50 Response

  At Week 16

• Percentage of Participants Achieving an EASI 90 Response

  At Week 16

• Percentage of Participants Achieving an EASI 100 Response

  At Week 16

• Percentage of Participants Achieving an Improvement (Reduction) of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS)

  At Week 16

Study Arms (2)

Sub-Study 1: Lutikizumab Monotherapy

EXPERIMENTAL

In Period 1, participants will be receive lutikizumab Dose A at Baseline randomization, followed by Dose B every other week starting at Week 2 for 16 weeks. participants will continue into Period 2 at Week 16 with Dose C every other week until Week 52.

Drug: Lutikizumab

Sub-Study 1: Placebo to Lutikizumab

EXPERIMENTAL

In Period 1, participants will be receive a matching placebo Dose A at Baseline randomization, followed by matching placebo Dose B every other week starting at Week 2 for 16 weeks. At Week 16, participants that were assigned placebo will then enter Period 2 and receive open-label lutikizumab Dose A , followed by lutikizumab Dose B every other week starting at Week 18, and lutikizumab Dose C every other week starting at Week 32 until Week 52.

Drug: Lutikizumab; Drug: Placebo

Interventions

Lutikizumab DRUG

Subcutaneous (SC) Injection

Also known as: ABT-981

Sub-Study 1: Lutikizumab Monotherapy; Sub-Study 1: Placebo to Lutikizumab

Placebo DRUG

Subcutaneous (SC) Injection

Sub-Study 1: Placebo to Lutikizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (30)

Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550

Fountain Hills, Arizona, 85268, United States

Location

Dermatology Research Associates - Los Angeles /ID# 272945

Los Angeles, California, 90045, United States

Location

Integrative Skin Science and Research /ID# 274243

Sacramento, California, 95815, United States

Location

Clinical Trials Research Institute /ID# 274234

Thousand Oaks, California, 91320, United States

Location

Western States Clinical Res /ID# 271748

Wheat Ridge, Colorado, 80033-2896, United States

Location

Skin Care Research Boca Raton /ID# 272544

Boca Raton, Florida, 33486-2269, United States

Location

Research Associates of South Florida /ID# 272549

Miami, Florida, 33134, United States

Location

Advanced Clinical Research Institute /ID# 272558

Tampa, Florida, 33607, United States

Location

Encore Medical Research - Weston /ID# 272539

Weston, Florida, 33331, United States

Location

Arlington Dermatology /ID# 271735

Rolling Meadows, Illinois, 60008, United States

Location

Somnos Clinical Research /ID# 272943

Lincoln, Nebraska, 68510, United States

Location

Equity Medical, LLC /ID# 272555

New York, New York, 10023-7340, United States

Location

Oregon Dermatology & Research Center /ID# 271733

Portland, Oregon, 97210, United States

Location

Clinical Partners /ID# 271791

Johnston, Rhode Island, 02919, United States

Location

Health Concepts /ID# 271744

Rapid City, South Dakota, 57702, United States

Location

Orion Clinical Research /ID# 274236

Austin, Texas, 78759, United States

Location

Complete Dermatology - Sugar Land /ID# 274240

Sugar Land, Texas, 77479, United States

Location

Dermatology Associates of Tyler /ID# 273684

Tyler, Texas, 75703, United States

Location

Center for Clinical Studies - Clear Lake /ID# 271749

Webster, Texas, 77598, United States

Location

Medical Corporation Kojinkai Sapporo Dermatology Clinic /ID# 273619

Sapporo, Hokkaido, 060-0063, Japan

Location

Kyoto University Hospital /ID# 275237

Kyoto, Kyoto, 606-8507, Japan

Location

Tachikawa Dermatology Clinic /ID# 273620

Tachikawa-shi, Tokyo, 190-0023, Japan

Location

Korea University Ansan Hospital /ID# 271786

Ansan-si, Gyeonggido, 15355, South Korea

Location

Soon Chun Hyang University Hospital Bucheon /ID# 271788

Bucheon-si, Gyeonggido, 14584, South Korea

Location

Seoul National University Hospital /ID# 271787

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Konkuk University Medical Center /ID# 271789

Seoul, Seoul Teugbyeolsi, 05030, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital /ID# 271785

Seoul, Seoul Teugbyeolsi, 07441, South Korea

Location

Royal United Hospital /ID# 274328

Bath, Bath And North East Somerset, BA1 3NG, United Kingdom

Location

Chapel Allerton Hospital /ID# 274762

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

Royal Liverpool University Hospital /ID# 272584

Liverpool, L7 8XP, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

lutikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (19); KR (5); GB (3); JP (3)