Clinical trial NCT04250350: Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
Official title: An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Dermira, Inc.
First posted: 2020-01-31
Enrollment: 206
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to \<18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.


Eligibility criteria: Inclusion Criteria:

1. Male or female adolescent (≥12 years to \<18 years, and weighing ≥40 kg).
2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.
6. History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.

Exclusion Criteria:

1. Participation in a prior lebrikizumab clinical study.
2. Treatment with the following prior to the baseline visit:

   1. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
   2. Dupilumab within 8 weeks.
   3. B-cell-depleting biologics, including to rituximab, within 6 months.
   4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.
5. Evidence of active acute or chronic hepatitis
6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
7. History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Primary outcomes:
measure: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs)
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline
timeFrame: Week 52
measure: Percentage of Participants Achieving ≥75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75)
timeFrame: Week 52
measure: Percentage Change From Baseline in EASI Score
timeFrame: Baseline, Week 52
measure: Percentage of Participants Achieving EASI-50 (≥50 Reduction From Baseline in EASI Score)
timeFrame: Week 52
measure: Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score)
timeFrame: Week 52
measure: Change From Baseline in Body Surface Area (BSA)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety
timeFrame: Baseline, Week 52
measure: Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Depression
timeFrame: Baseline, Week 52
measure: Change From Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
timeFrame: Baseline, Week 52
measure: Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab
timeFrame: Predose: Week 52
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: North Little Rock
country: United States
facility: Arkansas Research Trials, LLC
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fountain Valley
country: United States
facility: MD Studies
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: San Diego
country: United States
facility: University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Centennial
country: United States
facility: IMMUNOe International Research Centers
state: Colorado
city: Coral Gables
country: United States
facility: C&R Research Services USA
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education, LLC
state: Florida
city: Coral Gables
country: United States
facility: Pediatric Skin Research, LLC
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc.
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corp.
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research Inc
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Research
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers, Inc
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research
state: Georgia
city: Savannah
country: United States
facility: Georgia Skin & Cancer Clinic
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates LLC
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Topeka
country: United States
facility: Kansas Medical Clinic
state: Kansas
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Univ School of Med
state: Louisiana
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists
state: Maryland
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Saint Joseph
country: United States
facility: St Joseph Dermatology and Vein Clinic
state: Michigan
city: Saint Louis
country: United States
facility: Central Dermatology PC
state: Missouri
city: Portsmouth
country: United States
facility: ALLCUTIS Research
state: New Hampshire
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: Watertown
country: United States
facility: Advanced Asthma and Allergy
state: New York
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Tulsa
country: United States
facility: Central States Research
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Philadelphia
country: United States
facility: Paddington Testing Company Inc
state: Pennsylvania
city: Arlington
country: United States
facility: Arlington Research Center, Inc
state: Texas
city: Houston
country: United States
facility: Encore Imaging & Medical Research
state: Texas
city: Laredo
country: United States
facility: Cutis Wellness Dermatology
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Sugar Land
country: United States
facility: Acclaim Dermatology, PLLC
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Burke
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Sydney
country: Australia
facility: The Skin Hospital
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Parkville
country: Australia
facility: Royal Childrens Hospital Melbourne
state: Victoria
city: Victoria Park
country: Australia
facility: Burswood Dermatology
state: Western Australia
city: Nedlands
country: Australia
facility: Captain Stirling Medical Centre
city: Calgary
country: Canada
facility: Institute for Skin Advancement
state: Alberta
city: Red Deer
country: Canada
facility: CARe Clinic
state: Alberta
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials, Inc
state: Ontario
city: Toronto
country: Canada
facility: AvantDerm
state: Ontario
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
state: Lodzkie
city: Krakow
country: Poland
facility: Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"
state: Malopolskie
city: Krakow
country: Poland
facility: Diamond Clinic
state: Malopolskie
city: Warszawa
country: Poland
facility: Centrum Medyczne Evimed
state: Mazowieckie
city: Kielce
country: Poland
facility: Gabinet Dermatlogiczny. Beata Krecisz
state: Swietokrzyskie
city: Iwonicz Zdroj
country: Poland
facility: Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.
state: Wojewodztwo Podkarpackie
city: Katowice
country: Poland
facility: Provita Sp. z o.o
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
city: Wroclaw
country: Poland
facility: CityClinic Przychodnia Lekarsko-Psychologiczna
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: