A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
- Conditions
- Atopic dermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-002932-10-PL
- Lead Sponsor
- Dermira, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
- Male or female adults and adolescents (=12 to <18 years of age and weighing =40 kg).
- Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for =1 year before the screening visit.
- Eczema Area and Severity Index (EASI) score =16 at the baseline visit.
- Investigator Global Assessment (IGA) score =3 (scale of 0 to 4) at the baseline visit.
- =10% body surface area (BSA) of AD involvement at the baseline visit.
- History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
- For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo.
Note: A woman of childbearing potential (WOCBP) is defined as a
postmenarcheal female, who has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other
than menopause) and has not undergone surgical sterilization (removal of ovaries and/or uterus).
Note: The following are highly effective contraceptive methods:
combined (estrogen and 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 (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- Male patients must agree to use an effective barrier method of contraception during the study and for a minimum of 18 weeks following the last dose of study drug if sexually active with a female of child bearing potential
- Provide signed informed consent/assent.
Please see Protocol Section 4.1 for the full list of inclusion criteria.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
- Participation in a prior lebrikizumab clinical study.
- History of anaphylaxis as defined by the Sampson criteria.
- Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit.
- Prior treatment with dupilumab or tralokinumab.
- Treatment with any of the following agents within 4 weeks prior to the baseline visit:
a. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
b. Phototherapy and photochemotherapy (PUVA) for AD.
- Treatment with the following prior to the baseline visit:
a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
b. B Cell-depleting biologics, including to rituximab, within 6 months.
c. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
- Use of prescription moisturizers within 7 days of the baseline visit.
- Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
- Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
- Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma (defined by an ACQ-5 score =1.5 or a history of = 2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalization for > 24 hours).
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
Please see Protocol Section 4.2 for the full list of exclusion criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in patients with moderate-to-severe atopic dermatitis.;Secondary Objective: Not applicable;Primary end point(s): - The percentage of patients with an IGA score of 0 or 1 and a reduction =2 points from Baseline to Week 16.<br>- Percentage of patients achieving EASI-75 (=75% reduction from Baseline in EASI score) at Week 16;Timepoint(s) of evaluation of this end point: At week 16
- Secondary Outcome Measures
Name Time Method