NCT05149313CompletedPhase 3
A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine
A Randomised, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adult and Adolescent Patients With Moderate-To-Severe Atopic Dermatitis That Are Not Adequately Controlled With Cyclosporine or For Whom Cyclosporine is Not Medically Advisable.
Source: ClinicalTrials.gov · Last updated 20 May 2025
Brief summary (registry, in English)
The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 331 (actual)
- First submitted
- 26 Nov 2021
- Start date
- 23 Dec 2021
- Primary completion date
- 30 Jan 2023
- Lead sponsor
- Almirall, S.A.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05149313
- EudraCT number
- 2021-002967-23
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 331
- From 23 Dec 2021 to the primary completion date, 30 Jan 2023
- 48 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with TCS within 1 week before the Baseline visit.
- Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the Baseline visit.
- Treatment with interleukin 4 (IL-4) or interleukin 13 (IL-13) antagonists biological therapies before the Baseline visit. Exception: previous treatment with dupilumab will be allowed in a subset of patients
- Treatment with immunosuppressive/immunomodulating drugs, phototherapy and photochemotherapy within 4 weeks before the Baseline visit
Other illness
- Uncontrolled chronic disease that might require bursts of oral corticosteroids
- Serious, opportunistic, chronic or recurring infections within 3 months of Screening or before randomization
- Current or chronic infection with hepatitis B virus, current infection with hepatitis C virus, known liver cirrhosis and/or chronic hepatitis of any etiology
- Known or suspected history of immunosuppression, history of HIV infection or positive HIV serology at Screening
Lab values
- Any clinically significant laboratory test results obtained at the Screening visit
Other
- Presence of skin comorbidities that may interfere with study assessments
- Have had an important side effect to TCS that would prevent further use.
Who the study is looking for
- Adults and adolescents (aged greater than or equal to (\>=) 12 to \<18 years at the time of Informed Consent Form (ICF)/Informed Assent Form (IAF) and weighing \>=40 kilograms).
- Chronic AD that has been present for \>=1 year before the Screening visit.
- EASI score \>=16 at the Baseline Visit.
- IGA score \>=3 (moderate) (scale of 0 \[clear\] to 4 \[severe\]) at the Baseline visit.
- \>=10% BSA of AD involvement at the Baseline visit.
- Inadequate response to existing topical medications
- Failure to cyclosporine or non-medically advisable to receive/continue receiving cyclosporine
- Signed ICF (and informed assent for adolescents as required)
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.