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

  • End date
    Jan 15, 2024
  • participants needed
  • sponsor
    Almirall, S.A.
Updated on 15 June 2022
topical corticosteroid
topical agents


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.

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


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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note