Clinical trial NCT06718101: A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis
Official title: A Phase 2 Multicenter Platform Trial of Targeted Immunomodulator Therapies for Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Lutikizumab, ABT-981
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16
timeFrame: At Week 16
measure: Percentage of Participants Who Reported Adverse Events
timeFrame: Up to Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving an Improvement (Reduction) of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS)
timeFrame: At Week 4
measure: Percentage of Participants Achieving an EASI 50 Response
timeFrame: At Week 16
measure: Percentage of Participants Achieving an EASI 90 Response
timeFrame: At Week 16
measure: Percentage of Participants Achieving an EASI 100 Response
timeFrame: At Week 16
measure: Percentage of Participants Achieving an Improvement (Reduction) of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS)
timeFrame: At Week 16
measure: Absolute Change from Baseline for EASI
timeFrame: At Week 16
measure: Percent Change From Baseline in EASI Score
timeFrame: At Week 16
measure: Absolute Change from Baseline in Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
timeFrame: At Week 16
measure: Percentage of Participants Achieving a Validated Investigator´s Global Assessment for AD (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points
timeFrame: At Week 16
measure: Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS)
timeFrame: At Week 16
measure: Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS)
timeFrame: At Week 16
measure: Absolute Change from Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement
timeFrame: At Week 16
measure: Percent Change from Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement
timeFrame: At Week 16
Other outcomes:
Locations:
city: Fountain Hills
country: United States
facility: Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550
state: Arizona
city: Los Angeles
country: United States
facility: Dermatology Research Associates - Los Angeles /ID# 272945
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research /ID# 274243
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute /ID# 274234
state: California
city: Wheat Ridge
country: United States
facility: Western States Clinical Res /ID# 271748
state: Colorado
city: Boca Raton
country: United States
facility: Skin Care Research Boca Raton /ID# 272544
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida /ID# 272549
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute /ID# 272558
state: Florida
city: Weston
country: United States
facility: Encore Medical Research - Weston /ID# 272539
state: Florida
city: Rolling Meadows
country: United States
facility: Arlington Dermatology /ID# 271735
state: Illinois
city: Lincoln
country: United States
facility: Somnos Clinical Research /ID# 272943
state: Nebraska
city: New York
country: United States
facility: Equity Medical, LLC /ID# 272555
state: New York
city: Portland
country: United States
facility: Oregon Dermatology & Research Center /ID# 271733
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners /ID# 271791
state: Rhode Island
city: Rapid City
country: United States
facility: Health Concepts /ID# 271744
state: South Dakota
city: Austin
country: United States
facility: Orion Clinical Research /ID# 274236
state: Texas
city: Sugar Land
country: United States
facility: Complete Dermatology - Sugar Land /ID# 274240
state: Texas
city: Tyler
country: United States
facility: Dermatology Associates of Tyler /ID# 273684
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies - Clear Lake /ID# 271749
state: Texas
city: Sapporo-shi
country: Japan
facility: Medical Corporation Kojinkai Sapporo Dermatology Clinic /ID# 273619
state: Hokkaido
city: Tachikawa-shi
country: Japan
facility: Tachikawa Dermatology Clinic /ID# 273620
state: Tokyo
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital /ID# 271786
state: Gyeonggido
city: Bucheon-si
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon /ID# 271788
state: Gyeonggido
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: