A Study of Lebrikizumab in Combination With Topical Corticosteroids in Participants Having Atopic Dermatitis (AD) That Are Not Adequately Controlled or Non-eligible for Cyclosporine

  • STATUS
    Recruiting
  • End date
    Jan 15, 2024
  • participants needed
    312
  • sponsor
    Almirall, S.A.
Updated on 15 June 2022
corticosteroids
cyclosporine
topical corticosteroid
lebrikizumab
topical agents

Summary

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.

Details
Condition Dermatitis, Atopic, Eczema
Treatment Lebrikizumab, Lebrikizumab-matching Placebo
Clinical Study IdentifierNCT05149313
SponsorAlmirall, S.A.
Last Modified on15 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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 3 (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
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
Any clinically significant laboratory test results obtained at the Screening visit
Presence of skin comorbidities that may interfere with study assessments
Have had an important side effect to TCS that would prevent further use
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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