A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis
- Registration Number
- NCT06718101
- Lead Sponsor
- AbbVie
- 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.
...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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).
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sub-Study 1: Lutikizumab Monotherapy Lutikizumab 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. Sub-Study 1: Placebo to Lutikizumab Lutikizumab 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. Sub-Study 1: Placebo to Lutikizumab Placebo 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 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\...
Percentage of Participants Who Reported Adverse Events Up to Week 52 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 res...
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving an Improvement (Reduction) of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS) At Week 16 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Percentage of Participants Achieving an EASI 90 Response 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\...
Percentage of Participants Achieving an EASI 50 Response 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\...
Percentage of Participants Achieving an EASI 100 Response 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\...
Absolute Change from Baseline for EASI 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)...
Percent Change From Baseline in EASI Score 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)...
Absolute Change from Baseline in Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) At Week 16 The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
0 - Clear: No inflammatory signs of AD;
1. - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
...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 At Week 16 The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
* 0 - Clear: No signs of AD;
* 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
...Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS) At Week 16 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS) At Week 16 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Absolute Change from Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement At Week 16 Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA.
Percent Change from Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement At Week 16 Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA.