Atopic DermatitisPhase 2EMBARKNCT06718101
A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis
A Phase 2 study testing Lutikizumab in people with Atopic Dermatitis, run by AbbVie at 30 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lutikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 19 Dec 2024to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
United States19 sites
Orion Clinical Research /ID# 274236
Austin, Texas, 78759
Skin Care Research Boca Raton /ID# 272544
Boca Raton, Florida, 33486-2269
Peak Dermatology Aesthetics and Wellness Fountain Hills /ID# 272550
Fountain Hills, Arizona, 85268
Clinical Partners /ID# 271791
Johnston, Rhode Island, 02919
Somnos Clinical Research /ID# 272943
Lincoln, Nebraska, 68510
Dermatology Research Associates - Los Angeles /ID# 272945
Los Angeles, California, 90045
Research Associates of South Florida /ID# 272549
Miami, Florida, 33134
Equity Medical /ID# 272555
New York, New York, 10023-7340
Oregon Dermatology and Research Center /ID# 271733
Portland, Oregon, 97210
Health Concepts /ID# 271744
Rapid City, South Dakota, 57702
Arlington Dermatology /ID# 271735
Rolling Meadows, Illinois, 60008
Integrative Skin Science and Research /ID# 274243
Sacramento, California, 95815
Complete Dermatology - Sugar Land /ID# 274240
Sugar Land, Texas, 77479
Advanced Clinical Research Institute - Tampa /ID# 272558
Tampa, Florida, 33607
Clinical Trials Research Institute /ID# 274234
Thousand Oaks, California, 91320
Dermatology Associates of Tyler /ID# 273684
Tyler, Texas, 75703
Center for Clinical Studies - Clear Lake /ID# 271749
Webster, Texas, 77598
Encore Medical Research - Weston /ID# 272539
Weston, Florida, 33331
Western States Clinical Res /ID# 271748
Wheat Ridge, Colorado, 80033-2896
South Korea5 sites
Korea University Ansan Hospital /ID# 271786
Ansan-si, Gyeonggido, 15355
Soon Chun Hyang University Hospital Bucheon /ID# 271788
Bucheon-si, Gyeonggido, 14584
Seoul National University Hospital /ID# 271787
Seoul, Seoul Teugbyeolsi, 03080
Konkuk University Medical Center /ID# 271789
Seoul, Seoul Teugbyeolsi, 05030
Hallym University Kangnam Sacred Heart Hospital /ID# 271785
Seoul, Seoul Teugbyeolsi, 07441
Japan3 sites
Kyoto University Hospital /ID# 275237
Kyoto, Kyoto, 606-8507
Medical Corporation Kojinkai Sapporo Dermatology Clinic /ID# 273619
Sapporo, Hokkaido, 060-0063
Tachikawa Dermatology Clinic /ID# 273620
Tachikawa-shi, Tokyo, 190-0023
United Kingdom3 sites
Royal United Hospital /ID# 274328
Bath, Bath And North East Somerset, BA1 3NG
Chapel Allerton Hospital /ID# 274762
Leeds, West Yorkshire, LS7 4SA
Royal Liverpool University Hospital /ID# 272584
Liverpool, L7 8XP
About this study
Official title: A Phase 2 Multicenter Platform Trial of Targeted Immunomodulator Therapies for 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 will consist of multiple substudies. Substudy 1 will have a randomized, open-label period 1 followed by a lutikizumab treatment period 2 enrolling 80 participants at a 1 to 1 ratio.
Read more
In Substudy 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 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
- Being tested
- Lutikizumab, Placebo
- Keywords
- Lutikizumab
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LutikizumabDrug
Subcutaneous (SC) Injection
PlaceboDrug
Subcutaneous (SC) Injection
| Study group | Role | What they receive |
|---|---|---|
| Substudy 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. Receives: Drug: Lutikizumab |
| Substudy 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. Receives: Drug: Lutikizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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;
- - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
- - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
- - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;
- - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.
Measured: 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:
- 0 - Clear: No signs of AD;
- 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
- 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
- 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;
- 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start19 Dec 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718101
- Sponsor's protocol ID
- M24-727
- Acronym
- EMBARK
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter Platform Trial of Targeted Immunomodulator Therapies for Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06718101
- Acronym / sponsor ID
- EMBARK / M24-727
- Conditions
- Atopic Dermatitis
- Keywords
- Lutikizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 substudies. Substudy 1 will have a randomized, open-label period 1 followed by a lutikizumab treatment period 2 enrolling 80 participants at a 1 to 1 ratio.
In Substudy 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Substudy 1: Lutikizumab Monotherapy | Experimental | Drug: LutikizumabIn 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. |
| Substudy 1: Placebo to Lutikizumab | Experimental | Drug: Lutikizumab, Drug: PlaceboIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LutikizumabSubcutaneous (SC) Injection | Drug | Substudy 1: Lutikizumab Monotherapy, Substudy 1: Placebo to Lutikizumab |
| PlaceboSubcutaneous (SC) Injection | Drug | Substudy 1: Placebo to Lutikizumab |
Primary outcome
Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16
Time frame: 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.
Percentage of Participants Who Reported Adverse Events
Time frame: 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 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.
13 secondary outcomes
Percentage of Participants Achieving an Improvement (Reduction) of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS)
Time frame: At Week 4
Percentage of Participants Achieving an EASI 50 Response
Time frame: At Week 16
Percentage of Participants Achieving an EASI 90 Response
Time frame: At Week 16
Percentage of Participants Achieving an EASI 100 Response
Time frame: At Week 16
Percentage of Participants Achieving an Improvement (Reduction) of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS)
Time frame: At Week 16
Absolute Change from Baseline for EASI
Time frame: At Week 16
Percent Change From Baseline in EASI Score
Time frame: At Week 16
Absolute Change from Baseline in Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
Time frame: 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
Time frame: At Week 16
Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS)
Time frame: At Week 16
Absolute Change From Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS)
Time frame: At Week 16
Absolute Change from Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement
Time frame: At Week 16
Percent Change from Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement
Time frame: At Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lutikizumab in people with Atopic Dermatitis, run by AbbVie at 30 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, South Korea, Japan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 (time frame: At Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.