Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutikizumab | Drug | Subcutaneous (SC) Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving an Improvement (Reduction) of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS) | 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. |
Not provided
Inclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550 | Fountain Hills | Arizona | 85268 | United States | ||
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Subcutaneous (SC) Injection |
|
| At Week 4 |
| Percentage of Participants Achieving an EASI 50 Response | 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. An EASI 50 response is defined as at least a 50% reduction (improvement) from Baseline in EASI score. | At Week 16 |
| Percentage of Participants Achieving an EASI 90 Response | 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. An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score. | At Week 16 |
| Percentage of Participants Achieving an EASI 100 Response | 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. An EASI 100 response is defined as at least a 100% reduction (improvement) from Baseline in EASI score. | At Week 16 |
| Percentage of Participants Achieving an Improvement (Reduction) of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS) | 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. | At Week 16 |
| Absolute Change from Baseline for EASI | 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; a negative change from Baseline indicates improvement. | At Week 16 |
| Percent Change From Baseline in EASI Score | 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; a negative change from Baseline indicates improvement. | At Week 16 |
| Absolute Change from Baseline in Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) | 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;
| At Week 16 |
| 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 | The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
| At Week 16 |
| Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS) | 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. | At Week 16 |
| Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS) | 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. | At Week 16 |
| Absolute Change from Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement | 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. | At Week 16 |
| Percent Change from Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement | 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. | At Week 16 |
| Dermatology Research Associates - Los Angeles /ID# 272945 |
| Los Angeles |
| California |
| 90045 |
| United States |
| Integrative Skin Science and Research /ID# 274243 | Sacramento | California | 95815 | United States |
| Clinical Trials Research Institute /ID# 274234 | Thousand Oaks | California | 91320 | United States |
| Western States Clinical Res /ID# 271748 | Wheat Ridge | Colorado | 80033-2896 | United States |
| Skin Care Research Boca Raton /ID# 272544 | Boca Raton | Florida | 33486-2269 | United States |
| Research Associates of South Florida /ID# 272549 | Miami | Florida | 33134 | United States |
| Advanced Clinical Research Institute /ID# 272558 | Tampa | Florida | 33607 | United States |
| Encore Medical Research - Weston /ID# 272539 | Weston | Florida | 33331 | United States |
| Arlington Dermatology /ID# 271735 | Rolling Meadows | Illinois | 60008 | United States |
| Somnos Clinical Research /ID# 272943 | Lincoln | Nebraska | 68510 | United States |
| Equity Medical, LLC /ID# 272555 | New York | New York | 10023-7340 | United States |
| Oregon Dermatology & Research Center /ID# 271733 | Portland | Oregon | 97210 | United States |
| Clinical Partners /ID# 271791 | Johnston | Rhode Island | 02919 | United States |
| Health Concepts /ID# 271744 | Rapid City | South Dakota | 57702 | United States |
| Orion Clinical Research /ID# 274236 | Austin | Texas | 78759 | United States |
| Complete Dermatology - Sugar Land /ID# 274240 | Sugar Land | Texas | 77479 | United States |
| Dermatology Associates of Tyler /ID# 273684 | Tyler | Texas | 75703 | United States |
| Center for Clinical Studies - Clear Lake /ID# 271749 | Webster | Texas | 77598 | United States |
| Medical Corporation Kojinkai Sapporo Dermatology Clinic /ID# 273619 | Sapporo | Hokkaido | 060-0063 | Japan |
| Kyoto University Hospital /ID# 275237 | Kyoto | Kyoto | 606-8507 | Japan |
| Tachikawa Dermatology Clinic /ID# 273620 | Tachikawa-shi | Tokyo | 190-0023 | Japan |
| Korea University Ansan Hospital /ID# 271786 | Ansan-si | Gyeonggido | 15355 | South Korea |
| Soon Chun Hyang University Hospital Bucheon /ID# 271788 | Bucheon-si | Gyeonggido | 14584 | South Korea |
| Seoul National University Hospital /ID# 271787 | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Konkuk University Medical Center /ID# 271789 | Seoul | Seoul Teugbyeolsi | 05030 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital /ID# 271785 | Seoul | Seoul Teugbyeolsi | 07441 | South Korea |
| Royal United Hospital /ID# 274328 | Bath | Bath And North East Somerset | BA1 3NG | United Kingdom |
| Chapel Allerton Hospital /ID# 274762 | Leeds | West Yorkshire | LS7 4SA | United Kingdom |
| Royal Liverpool University Hospital /ID# 272584 | Liverpool | L7 8XP | United Kingdom |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000655035 | lutikizumab |
Not provided
Not provided
Not provided