Clinical trial NCT04626297: A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)
Official title: A Phase 3, 16-week, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Assess the Impact of Lebrikizumab on Vaccine Responses in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Eczema
Skin Diseases
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-11-12
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The reason for this study is to assess the impact of lebrikizumab on vaccine immune response in adult participants with moderate to severe atopic dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

* Chronic atopic dermatitis (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 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.
* Have not received any tetanus-containing vaccine within approximately 5 years of baseline.
* Have never received a meningococcal conjugate vaccine or have received not more than 1 prior MCV dose at least 4 years prior to baseline, of a vaccine containing 1 or more meningococcal serogroups (serogroups A, C, W, Y).
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

  * a. Female participants of childbearing potential: must 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 study drug. Women of non-childbearing potential (non-WOCBP) may participate without any contraception requirements.
  * b. Male participants are not required to use any contraception except in compliance with specific local government study requirements.

Exclusion Criteria:

* Recurring herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis
* Evidence of active or chronic hepatitis
* History of human immunodeficiency virus (HIV) infection or positive HIV serology.
* Presence of skin comorbidities that may interfere with study assessments.
* History of malignancy, including mycosis fungoides, within 5 years before screening, except completely treated in situ carcinoma of the cervix or completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
* Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma.
* Have a prior history of Guillain-Barre syndrome.
* Allergic to latex.
* History of past vaccination allergy or Arthus-type hypersensitivity.
* Have an uncontrolled seizure disorder.
* Have known hypogammaglobulinemia or a screening serum immunoglobulin G (IgG) or immunoglobulin A (IgA) concentration less than the lower limit of the reporting laboratory's reference range.
* Treated with topical corticosteroids (TCS), calcineurin inhibitors, or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit.
* Treated with the following prior to 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 rituximab, within 6 months
  * c. Other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer
* Received a Bacillus Calmette-Guerin (BCG) vaccination or treatment within 12 months of screening, or treated with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
* A contraindication to the Tdap vaccine or mean corpuscular volume (MCV).
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Primary outcomes:
measure: Percentage of Participants Who Develop a Booster Response to Tetanus Toxoid 4 Weeks After Tdap (Tetanus-diphtheria-pertussis) Vaccine Administration
timeFrame: Week 16
measure: Percentage of Participants Who Have Positive Antibody Response to Meningococcus C Antigen 4 Weeks After Meningococcal Conjugate Vaccine (MCV) Administration
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction of ≥2 Points From Baseline
timeFrame: Week 16
measure: Percentage of Participants Achieving a ≥75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-75)
timeFrame: Week 16
measure: Percentage of Participants Achieving ≥90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-90)
timeFrame: Week 16
measure: Percentage of Participants Achieving ≥4-Point Improvement From Baseline in Pruritus Numeric Rating Scale (NRS) Score
timeFrame: Week 16
measure: Change From Baseline in Percent Body Surface Area (BSA)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Sleep-Loss Score
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama- Birmingham
state: Alabama
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Research Trials
state: Arkansas
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Beverly Hills
country: United States
facility: Wallace Medical Group, Inc.
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: Inglewood
country: United States
facility: Axon Clinical Research
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research
state: California
city: Laguna Niguel
country: United States
facility: Avance Trials
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine University of Southern California
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Los Angeles
country: United States
facility: LA Universal Research Center, INC
state: California
city: Manhattan Beach
country: United States
facility: Ablon Skin Institute and Research Center
state: California
city: Newport Beach
country: United States
facility: Dermatology Clinical Trials
state: California
city: Palmdale
country: United States
facility: Cura Clinical Research
state: California
city: San Diego
country: United States
facility: MD Strategies Research Centers MDSRC
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: San Francisco
country: United States
facility: Synergy Dermatology
state: California
city: San Jose
country: United States
facility: Care Access Research
state: California
city: San Luis Obispo
country: United States
facility: San Luis Dermatology & Laser Clinic
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: Colorado Springs
country: United States
facility: Asthma and Allergy Associates, PC
state: Colorado
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education, LLC
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Hialeah
country: United States
facility: The Community Research of South Florida
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research
state: Florida
city: Kendall
country: United States
facility: C&R Research Services USA
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research Inc
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Research
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc
state: Florida
city: Pembroke Pines
country: United States
facility: Riverchase Dermatology and Cosmetic Surgery
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
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: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates LLC
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Shawnee Mission
country: United States
facility: Kansas Medical Clinic, an Elligo Health Research, Inc.
state: Kansas
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: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Auburn Hills
country: United States
facility: Oakland Dermatology
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Omaha
country: United States
facility: Advanced Dermatology of the Midlands
state: Nebraska
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology
state: New Jersey
city: New York
country: United States
facility: JUVA Skin & Laser Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Central States Research
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: Peak Research LLC
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Warwick
country: United States
facility: AAPRI Clinical Research Institute
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Arlington
country: United States
facility: Arlington Research Center, Inc
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Dripping Springs
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: Laredo
country: United States
facility: Laredo Dermatology Associates P.A.
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: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: Velocity Clinical Research - Woseth Dermatology
state: Utah
city: South Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
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: