Study Description
Brief Summary
The study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD) previously treated with Dupilumab.
Condition or Disease
Moderate-to-Severe Atopic Dermatitis
Study Design
| Study Type: | Interventional (Clinical Trial) |
| Actual Enrollment: | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label, Study to Evaluate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab |
| Actual Study Start Date: | December 19, 2022 |
| Actual Primary Completion Date: | October 31 2023 |
| Actual Study Completion Date: | March 15, 2024 |
Eligibility Criteria
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- All participants must have prior treatment with dupilumab meeting one of the following conditions:
- Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab (at labeled dose level) for at least 4 months.
- Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment.
- Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment.
- Participants who have chronic AD that has been present for ≥1 year before screening.
- Have EASI ≥16 at baseline
- Have IGA score ≥3 (Scale of 0 to 4) at baseline
- Have ≥10% body surface area (BSA) of AD involvement at baseline
- Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
- Adolescents body weight must be ≥40 kg at baseline.
Exclusion Criteria
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- Have a current infection or chronic infection with hepatitis B virus (HBV) at screening (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA
- Have a current infection with hepatitis C virus (HCV) at screening (that is, positive for HCV RNA
- Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator.
- Have uncontrolled asthma that
- might require bursts of oral or systemic corticosteroids, or
- required the following due to ≥1 exacerbations within 12 months before baseline
- systemic (oral and/or parenteral) corticosteroid treatment, or
- hospitalization for >24 hours.
- Have known liver cirrhosis and/or chronic hepatitis of any etiology.
- Had Dupilumab treatment within 4 weeks prior to baseline
- Had prior treatment with tralokinumab.
- Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline
- Treatment with any of the following agents within 4 weeks prior to the baseline
- systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants)
- small molecules (e.g. JAK inhibitors)
- phototherapy and photochemotherapy for AD