Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)

Phase 3

Completed

Conditions: Atopic Dermatitis

Interventions: Biological: Lebrikizumab

Registration Number: NCT04392154

Lead Sponsor: Eli Lilly and Company

Brief Summary: This is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis. It will last up to 33 months.

Detailed Description: Participants who have completed participation in a Dermira- or Lilly-sponsored lebrikizumab study (parent study), DRM06-AD04 (NCT04146363), DRM06-AD05 (NCT04178967), DRM06-AD06 (NCT04250337), DRM06-AD17 (NCT04250350) or DRM06- AD18 (NCT04626297), will be offered the opportunity to enroll in this study. Participants may either be blinded or not blinded, depending on their parent study assignment.

This study will also be open to an additional approximately 100 participants in the United States (addendum) who have not completed participation in a Dermira- or Lilly-sponsored lebrikizumab study. Treatment will not be blinded.

This study will also include an Addendum to extend the study treatment period by an additional 32 weeks and to add a treatment arm testing dosing every 8 weeks. This Addendum will apply to existing study participants in selected countries. Treatment will not be blinded.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1153

Inclusion Criteria

Participants must meet all the following criteria to be eligible for this study addendum:

Male or female adults and adolescents (≥12 to <18 years of age and weighing ≥40 kilogram (kg).
Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening.
Eczema Area and Severity Index (EASI) score ≥16 at baseline.
Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at baseline.
≥10% body surface area (BSA) of AD involvement at baseline.
History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.

Open-Label Addendum

Exclusion Criteria

Participants meeting any of the criteria below will be excluded from this study addendum:

Have received a dose of lebrikizumab in any prior lebrikizumab clinical study.
History of anaphylaxis
Treatment with topical prescription moisturizers, corticosteroids, calcineurin inhibitors, or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to baseline.
Treatment with any of the following agents within 4 weeks prior to the baseline.
- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon gamma (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy and photochemotherapy (PUVA) for AD.
Treatment with the following prior to baseline:
- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy and photochemotherapy (PUVA) for AD.
Treatment with the following prior to baseline:
- An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
- B Cell-depleting biologics, including rituximab, within 6 months.
- Other Biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
Regular use (more than 2 uses per week) of a tanning booth/parlor within 4 weeks of baseline.
Treatment with a live (attenuated) vaccine within 12 weeks of the baseline or planned during the study.
Uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma, (as defined by the investigator).
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
Evidence of active acute or chronic hepatitis
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
History of malignancy, including mycosis fungoides, within 5 years before screening, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.

Open-Label Extension Addendum Inclusion Criteria:

Have completed Week 100 of Study KGAA and have not yet completed the safety follow-up visit for the main study.

Open-Label Extension Addendum Exclusion Criteria:

Have initiated treatment with a medication prohibited by Study KGAA before addendum baseline. This includes use of biologics for AD (for example, dupilumab and tralokinumab) during the safety follow-up period of Study KGAA.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lebrikizumab Q2W (Primary Treatment Period)	Lebrikizumab	250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
Lebrikizumab Q4W (Primary Treatment Period)	Lebrikizumab	250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.
Open-Label Extension Addendum	Lebrikizumab	Eligible participants from primary treatment period could enter open-label extension addendum to receive either Lebrikizumab Q4W or Q8W or Q2W by SC injection.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Discontinued From Study Treatment Due to Adverse Events	Baseline to Week 100	Percentage of participants discontinued from study treatment due to adverse events is reported.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100	Week 100	The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis. The IGA is comprised of a 5-point numeric scale ranging from 0 (clear skin) to 4 (severe disease) and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point.
Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100	Week 100	EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity.

Trial Locations

Locations (313): Avance Clinical Trials Inc
🇺🇸
Laguna Niguel, California, United States
Hospital Universitario Infanta Leonor
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Madrid, Spain
Pinnacle Research Group, LLC
🇺🇸
Anniston, Alabama, United States
Clinical Research Center of Alabama- Birmingham
🇺🇸
Birmingham, Alabama, United States
Investigate MD
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Scottsdale, Arizona, United States
Johnson Dermatology
🇺🇸
Fort Smith, Arkansas, United States
Burke Pharmaceutical Research
🇺🇸
Hot Springs, Arkansas, United States
Arkansas Research Trials
🇺🇸
North Little Rock, Arkansas, United States
Northwest Arkansas Clinical Trials Center
🇺🇸
Rogers, Arkansas, United States
Orange County Research Institute
🇺🇸
Anaheim, California, United States
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Avance Clinical Trials Inc
🇺🇸Laguna Niguel, California, United States