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

Official 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.

Eligibility Requirements

• Minimum Age: 12 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 86 participants

Study Arms

• Lebrikizumab 250 mg Q2W (EXPERIMENTAL)
  Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16.
• Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W (EXPERIMENTAL)
  Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve Investigator Global Assessment (IGA) 0 or 1 (clear or almost clear) or a 75% reduction in the Eczema Area and Severity Index (EASI) score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. Eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation
• Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W (EXPERIMENTAL)
  Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. Eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.

Interventions

• DRUG: Lebrikizumab — Administered SC

Primary Outcomes

• Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75) at Week 16 (Week 16)

Secondary Outcomes

• Percentage of Participants Achieving EASI-75 at Week 24 (Week 24)
• Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 (Baseline to Week 16)
• Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24 (Baseline to Week 24)
• Percentage Change From Baseline in EASI Total Score From Baseline to Week 16 (Baseline, Week 16)
• Percentage Change From Baseline in EASI Score From Baseline to Week 24 (Baseline, Week 24)

Eligibility Criteria

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

Trial Locations

• River Region Dermatology and Laser, Montgomery, Alabama, United States
• Medical Dermatology Specialists, Phoenix, Arizona, United States
• First OC Dermatology, Fountain Valley, California, United States
• Axon Clinical Research, Inglewood, California, United States
• Avance Clinical Trials Inc, Laguna Niguel, California, United States
• Dermatology Research Associates, Los Angeles, California, United States
• Wallace Medical Group, Inc., Los Angeles, California, United States
• Clinical Science Institute, Santa Monica, California, United States
• Cura Clinical Research, Sherman Oaks, California, United States
• UConn Health, Farmington, Connecticut, United States
• ...and 10 more locations

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) — STUDY_DIRECTOR
  Eli Lilly and Company

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