A Study of of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

Last updated: July 24, 2024
Sponsor: Almirall, S.A.
Overall Status: Active - Recruiting

Phase

3

Condition

Dermatitis, Atopic

Rash

Allergies & Asthma

Treatment

Lebrikizumab

Clinical Study ID

NCT06526182
M-17923-34
2023-508235-31
  • Ages > 12
  • All Genders

Study Summary

The main purpose of this study is to evaluate the effectiveness and safety of 24 weeks of lebrikizumab in improving disease severity, signs, and symptoms in adults and adolescents with moderate-to-severe AD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults and adolescents (aged greater than or equal to [>=] 12 to less than [<] 18 atthe time of informed consent form [ICF]/informed assent form [IAF] signature andweighing 40 >= kilograms [kg]) who are candidates for systemic AD therapy.

  2. Chronic AD (according to Hanifin and Rajka Criteria (Hanifin 1980)) that has beenpresent for >= 1 year before the screening visit.

  3. EASI score >= 12 at the Day 1/Baseline Visit.

  4. IGA score >= 3 (moderate) (scale of 0 [clear] to 4 [severe]) at the Day 1/Baselinevisit.

  5. >= 10% BSA of AD involvement at the Day 1/Baseline visit.

  6. History of inadequate response to treatment with topical medications; ordetermination that topical treatments are otherwise medically inadvisable.

  7. Completed electronic diary (eDiary) entries for pruritus and sleep-loss for aminimum of 4 of 7 days before Day 1/Baseline.

  8. Willing and able to comply with all clinic visits and study-related procedures andquestionnaires.

  9. For women of childbearing potential: agree to remain abstinent (refrain fromheterosexual intercourse) or to use a highly effective contraceptive method duringthe treatment period and for at least 4 weeks or 1 menstrual period after the lastdose of lebrikizumab. NOTE: A woman of childbearing potential (WOCBP) is defined as a post menarchealamenorrhea with no identified cause other than menopause) and has not undergonesurgical sterilization (removal of ovaries and/or uterus). NOTE: The following contraceptive methods are highly effective: combined (oestrogenand progestogen containing) hormonal contraception (oral, intravaginal, transdermal)associated with inhibition of ovulation, progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation,intrauterine device, intrauterine hormone-releasing system, bilateral tubalocclusion, vasectomised partner, or sexual abstinence. The reliability of sexualabstinence should be evaluated in relation to the duration of the clinical trial andthe preferred and usual lifestyle of the participant. Periodic abstinence (e.g.,calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal arenot acceptable methods of contraception.

  10. Participant must provide signed ICF. Adolescent participants must also provideseparate informed assent to enroll in the study and sign and date either a separateIAF or the ICF signed by the parent/legal guardian (as appropriate based on localregulations and requirements).

Exclusion

Exclusion Criteria:

  1. Prior treatment at any time with tralokinumab, lebrikizumab, or an oral JAKinhibitor.

  2. Intention to use any concomitant medication or therapy that is not permitted by thisprotocol or failure to undergo the required washout period for a particularprohibited medication.

  3. History of anaphylaxis as defined by the Sampson criteria (Sampson 2006).

  4. Uncontrolled chronic disease that might require bursts of oral corticosteroids, eg,comorbid severe uncontrolled asthma (defined by an Asthma Control Questionnaire-5score >= 1.5 or a history of >= 2 asthma exacerbations within the last 12 monthsrequiring systemic [oral and/or parenteral] corticosteroid treatment orhospitalisation for >24 hours).

  5. Occurrence of the following types of infection within 3 months before or duringscreening or development of these infections before Day 1/Baseline:

  6. Serious (requiring hospitalisation, and/or IV or equivalent oral antibiotictreatment, as per the Investigator's opinion);

  7. Opportunistic (as defined by Winthrop et al. (Winthrop 2015)) NOTE: Herpeszoster is considered active and ongoing until all vesicles are dry and crustedover;

  8. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer);

  9. Recurring (including, but not limited to herpes simplex, herpes zoster,recurring cellulitis, chronic osteomyelitis).

  10. Known current or chronic infection with any hepatitis virus.

  11. Known liver cirrhosis and/or chronic hepatitis of any aetiology.

  12. Known active endoparasitic infection or at high risk of these infections.

  13. Known or suspected history of immunosuppression, including history of invasiveopportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis,coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution:or unusually frequent, recurrent, or prolonged infections, per the Investigator'sjudgement.

  14. History of human immunodeficiency virus (HIV) infection or known positive HIVserology.

  15. Any clinically significant laboratory test results from the chemistry or haematologytests obtained at the Screening visit that would jeopardise the participantsparticipation in the study, per the Investigator's judgement.

  16. Presence of skin comorbidities that may interfere with study assessments.

  17. History of malignancy, including mycosis fungoides, within 5 years before theScreening visit, except completely treated in situ carcinoma of the cervix,completely treated and resolved nonmetastatic squamous or basal cell carcinoma ofthe skin with no evidence of recurrence in the past 12 weeks.

  18. Severe concomitant illness(es) that in the Investigator's judgement would adverselyaffect the participation in the study. Any other medical or psychological conditionthat in the opinion of the Investigator may suggest a new and/or insufficientlyunderstood disease, may present an unreasonable risk to the study participantbecause of his/her participation in this clinical trial, may make participationunreliable, or may interfere with study assessments.

  19. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeedduring the study.

  20. For the scratch sensor substudy only: a history of allergic response to skinadhesives, active skin or systemic infection, active AD on the back of the hand, ora pre-existing sleep disorder, including insomnia, obstructive sleep apnea, orrestless leg syndrome, or currently taking prescription sleep medications.

Study Design

Total Participants: 520
Treatment Group(s): 1
Primary Treatment: Lebrikizumab
Phase: 3
Study Start date:
July 03, 2024
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Hospital General Universitario Dr. Balmis

    Alicante,
    Spain

    Active - Recruiting

  • Hospital del Mar - Parc de Salut Mar

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario Clínico San Cecilio

    Granada,
    Spain

    Active - Recruiting

  • Consorci Hospital General Universitari de València

    Valencia,
    Spain

    Active - Recruiting

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