A 2-year Open-label Extension Study to Assess the Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Dermatitis

Almirall, S.A.32 sites in 2 countries200 target enrollmentMay 23, 2023

ConditionsAtopic Dermatitis

InterventionsLebrikizumab

Overview

Phase: Phase 3
Intervention: Lebrikizumab
Conditions: Atopic Dermatitis
Sponsor: Almirall, S.A.
Enrollment: 200
Locations: 32
Primary Endpoint: Proportion of the Participants who will Discontinue from Study Treatment due to Treatment-emergent Adverse Events (TEAEs)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of the study is to assess the long-term tolerability and effectiveness of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD). Participants who complete the last assessment visit in ADjoin (Week 100) will be offered the opportunity to enroll in this extension study.

Registry

clinicaltrials.gov

Start Date

May 23, 2023

End Date

April 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Almirall, S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants who completed treatment with lebrikizumab in ADjoin and their last participant assessment visit (Week 100) in that study.
•For WOCBP: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 4 weeks after the last dose of lebrikizumab.
•NOTE: A 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, fallopian tubes, 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, intrauterine hormone-releasing system, bilateral tubal occlusion, bilateral tubal ligation, vasectomized partner, or sexual abstinence. In the context of this protocol, sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. 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 participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.
•Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol and provide written informed consent/assent in accordance with institutional and regulatory guidelines.
•Capable of giving signed informed consent/assent as described in which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

•Participants who, having participated in ADjoin, had their last lebrikizumab dose administered in a window longer than 8 weeks prior to the Baseline Visit in the current study.
•Participants who, during their participation in the parent trial or ADjoin, developed an SAE or a severe AE that was deemed related to lebrikizumab, which in the opinion of the Investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
•Conditions in the parent study or ADjoin consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to lebrikizumab or led to Investigator or Sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.).
•Treatment with a live (attenuated) vaccine from the time of last lebrikizumab dose in ADjoin prior to enrolment in the current study or planned during the study.
•Use of a prohibited medication from the time of last lebrikizumab dose in ADjoin prior to enrolment in the current study or planned during the study.
•Pregnant or breastfeeding women, and women planning to become pregnant or breastfeed during the study and for at least 4 weeks after the last dose of lebrikizumab.
•Severe concomitant illness(es) that in the Investigator's judgment would adversely affect the participant's participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient because of his/her participation in this clinical trial, may make participant's participation unreliable, or may interfere with study assessments.
•Any other conditions that, in the Investigator's opinion, might indicate the participant to be unsuitable for the trial.
•Participant who is an employee or relative of an employee at the research site or Almirall.

Arms & Interventions

Lebrikizumab

Adult and adolescent participants (12 to less than \[\<\] 18 years and weighing greater than or equal to \[\>=\] 40 kilogram \[kg\]) with moderate-to-severe AD will receive lebrikizumab 250 milligrams (mg) subcutaneous (SC) injection via pre-filled syringe (PFS) for every fourth week (Q4W) for up to Week 104. If participants response is below EASI50 at any visit, lebrikizumab dosing frequency may be increased to every two weeks (Q2W) at any time during the course of the study; thereafter, lebrikizumab Q4W dosing may be resumed at the Investigator's discretion. Lebrikizumab will be administered up to Week 106 for participants who continue Q2W dosing, and these participants will undergo a safety follow-up assessment at Week 110.

Intervention: Lebrikizumab

Outcomes

Primary Outcomes

Proportion of the Participants who will Discontinue from Study Treatment due to Treatment-emergent Adverse Events (TEAEs)

Time Frame: Baseline up to Week 110

Secondary Outcomes

Percentage Change from Baseline of Parent study in EASI Score(Baseline up to Week 108)
Percentage of Participants with EASI Score <=7(Baseline up to Week 108)
Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1(Baseline up to Week 108)
Percentage Change From Baseline of Parent Study in Body Surface Area (BSA) Involvement(Baseline to Week 108)
Percentage of Participants with DLQI/CDLQI Score <=5(Baseline up to Week 108)
Percentage of Participants with Eczema Area and Severity Index (EASI) 50, EASI 75, and EASI 90 (>=50%, >=75%, and >=90%) Reduction in EASI Scores(Baseline up to Week 108)
Percentage of Participants Achieving Pruritus Numeric Rating Score (NRS) <= 4(Baseline up to Week 108)
Proportion of Participants with Topical Corticosteroids (TCS)-free Days(Baseline up to Week 108)
Percentage of Participants Achieving at Least a 4-point Improvement from Baseline of Parent Study Dermatology Quality of Life Index/ Children's Dermatology Quality of Life Index (DLQI/CDLQI)(Baseline to Week 108)