AzTrials
AzTrials

Atopic DermatitisPhase 3NCT04626297

A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)

A Phase 3 study testing Lebrikizumab in people with Atopic Dermatitis, run by Eli Lilly and Company at 85 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Lebrikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
254 participants
Where
85 sitesUnited States
Study dates
17 Nov 2020to 30 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

85 sites in 1 country.

85 sites in 1 country

United States85 sites

  • Orange County Research Institute

    Anaheim, California, 92801

  • Arlington Research Center, Inc

    Arlington, Texas, 76011

  • Oakland Dermatology

    Auburn Hills, Michigan, 48326

  • Bellaire Dermatology Associates

    Bellaire, Texas, 77401

  • Wallace Medical Group, Inc.

    Beverly Hills, California, 90211

  • Clinical Research Center of Alabama- Birmingham

    Birmingham, Alabama, 35244

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Metro Boston Clinical Partners

    Brighton, Massachusetts, 02135

  • IMMUNOe International Research Centers

    Centennial, Colorado, 80112

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Asthma and Allergy Associates, PC

    Colorado Springs, Colorado, 80907-6231

  • Florida Academic Centers Research and Education, LLC

    Coral Gables, Florida, 33134

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230

  • Modern Research Associates

    Dallas, Texas, 75231

  • Ohio Pediatric Research Association

    Dayton, Ohio, 45414

  • Austin Institute for Clinical Research

    Dripping Springs, Texas, 78620

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Center For Dermatology Clinical Research, Inc.

    Fremont, California, 94538

  • Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology

    Hackensack, New Jersey, 07601

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • The Community Research of South Florida

    Hialeah, Florida, 33016

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913

  • Center for Clinical Studies

    Houston, Texas, 77004

  • Suzanne Bruce and Associates, PA

    Houston, Texas, 77056

  • Axon Clinical Research

    Inglewood, California, 90301

  • Solutions Through Advanced Research

    Jacksonville, Florida, 32256

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • C&R Research Services USA

    Kendall, Florida, 33183

  • Sunwise Clinical Research

    Lafayette, California, 94549

  • Avance Trials

    Laguna Niguel, California, 92677

  • Laredo Dermatology Associates P.A.

    Laredo, Texas, 78041

  • Keck School of Medicine University of Southern California

    Los Angeles, California, 90033

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • LA Universal Research Center, INC

    Los Angeles, California, 90057

  • Skin Sciences, PLLC

    Louisville, Kentucky, 40217

  • Ablon Skin Institute and Research Center

    Manhattan Beach, California, 90266

  • International Dermatology Research, Inc.

    Miami, Florida, 33144

  • Sanchez Clinical Research Inc

    Miami, Florida, 33157

  • New Horizon Research Center

    Miami, Florida, 33165

  • Miami Dermatology and Laser Research

    Miami, Florida, 33173

  • Florida Research Center, Inc

    Miami, Florida, 33174

  • Wellness Clinical Research

    Miami Lakes, Florida, 33016

  • Tulane Univ School of Med

    New Orleans, Louisiana, 70112

  • JUVA Skin & Laser Center

    New York, New York, 10022-3350

  • Dermatology Clinical Trials

    Newport Beach, California, 92660

  • Sneeze, Wheeze, & Itch Associates LLC

    Normal, Illinois, 61761

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72117

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118

  • Advanced Dermatology of the Midlands

    Omaha, Nebraska, 68144

  • Kansas City Dermatology, PA

    Overland Park, Kansas, 66215

  • Cura Clinical Research

    Palmdale, California, 93551

  • Riverchase Dermatology and Cosmetic Surgery

    Pembroke Pines, Florida, 33028

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Oregon Medical Research Center

    Portland, Oregon, 97223

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Velocity Clinical Research - Woseth Dermatology

    Salt Lake City, Utah, 84117

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • MD Strategies Research Centers MDSRC

    San Diego, California, 92119

  • University Clinical Trials

    San Diego, California, 92123

  • Synergy Dermatology

    San Francisco, California, 94132

  • Care Access Research

    San Jose, California, 95117

  • San Luis Dermatology & Laser Clinic

    San Luis Obispo, California, 93405

  • Advanced Medical Research

    Sandy Springs, Georgia, 30328

  • Southern California Dermatology, Inc.

    Santa Ana, California, 92701

  • Georgia Skin & Cancer Clinic

    Savannah, Georgia, 31419

  • Kansas Medical Clinic, an Elligo Health Research, Inc.

    Shawnee Mission, Kansas, 66216

  • Jordan Valley Dermatology Center

    South Jordan, Utah, 84095

  • Premier Clinical Research

    Spokane, Washington, 99202

  • Tampa General Hospital

    Tampa, Florida, 33612

  • ForCare Clinical Research

    Tampa, Florida, 33613-1244

  • Olympian Clinical Research

    Tampa, Florida, 33614

  • Kansas Medical Clinic

    Topeka, Kansas, 66614

  • Central States Research

    Tulsa, Oklahoma, 74136

  • Vital Prospects Clinical Research Institute, PC

    Tulsa, Oklahoma, 74136

  • Peak Research LLC

    Upper Saint Clair, Pennsylvania, 15241

  • Grekin Skin Institute

    Warren, Michigan, 48088

  • AAPRI Clinical Research Institute

    Warwick, Rhode Island, 02886

  • Center for Clinical Studies

    Webster, Texas, 77598

  • Dundee Dermatology

    West Dundee, Illinois, 60118

Other trials in United States

About this study

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

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).

Being tested
Lebrikizumab, Placebo
Keywords
Eczema, Skin Diseases
Medical subject headings
Dermatitis, Atopic, Eczema, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LebrikizumabDrug

    Also called LY3650150, DRM06

    Given SC

  • PlaceboDrug

    Given SC

Study groups in NCT04626297
Study groupRoleWhat they receive
LebrikizumabExperimentalParticipants received a loading dose of 500 milligram (mg) lebrikizumab injection administered subcutaneously (SC) at baseline and week 2, and 250 mg once every two weeks (Q2W) from week 4 to 14.
Receives: Drug: Lebrikizumab
PlaceboPlacebo comparatorParticipants received placebo SC injection Q2W from baseline to week 14.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Develop a Booster Response to Tetanus Toxoid 4 Weeks After Tdap (Tetanus-diphtheria-pertussis) Vaccine Administration

    Booster response to tetanus toxoid is defined as: ≥4-fold increase in anti-tetanus toxoid immunoglobulin G (IgG) antibody concentration if the pre-vaccination level was >0.10 International units per milliliter (IU/mL) and ≤2.7 IU/mL; OR ≥2-fold increase in anti-tetanus toxoid IgG antibody concentration if the pre-vaccination level was >2.7 IU/mL; OR ≥4-fold increase in anti-tetanus toxoid IgG antibody concentration and a post-vaccination level ≥0.10 IU/mL if the pre-vaccination level was ≤0.10 IU/mL

    Measured: Week 16

  2. Percentage of Participants Who Have Positive Antibody Response to Meningococcus C Antigen 4 Weeks After Meningococcal Conjugate Vaccine (MCV) Administration

    Positive antibody response to Meningococcus C antigen as measured by group C serum bactericidal antibodies is defined as: post-vaccination rabbit complement serum bactericidal assay (rSBA) titer ≥4 times the lower limit of quantitation (LLOQ), if the pre-vaccination rSBA titer is less than the LLOQ; OR post-vaccination rSBA titer ≥4 times the pre-vaccination titer, if the pre-vaccination rSBA titer is greater than or equal to the LLOQ.

    Measured: Week 16

Secondary outcomes (6)

  1. Percentage of Participants Achieving an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction of ≥2 Points From Baseline

    The IGA measures the investigator's global assessment of the participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Markov Chain Monte Carlo Multiple Imputation (MCMC-MI) was used to handle missing data.

    Measured: Week 16

  2. Percentage of Participants Achieving a ≥75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-75)

    The EASI-75 is defined as a ≥ 75% improvement from baseline in the EASI score. 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. MCMC-MI was used to handle missing data.

    Measured: Week 16

  3. Percentage of Participants Achieving ≥90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-90)

    The EASI-90 is defined as a ≥ 90% improvement from baseline in the EASI score. 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. MCMC-MI was used to handle missing data.

    Measured: Week 16

  4. Percentage of Participants Achieving ≥4-Point Improvement From Baseline in Pruritus Numeric Rating Scale (NRS) Score

    The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." MCMC-MI was used to handle missing data.

    Measured: Week 16

  5. Change From Baseline in Percent Body Surface Area (BSA)

    The BSA assessment estimates the extent of disease or skin involvement with respect to AD and is expressed as a percentage of body surface area. It was assessed for 4 body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100%. BSA was calculated using the participant's palm, 1 palm = 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 for head and neck (10%), 20 for upper extremities (20%), 30 for trunk, including axilla and groin (30%), and 40 for lower extremities, including buttocks (40%). Percent of BSA for a body region = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA for an individual is arithmetic mean of % BSA of all 4 body regions and ranges from 0% to 100% with higher values representing greater severity of AD.

    Measured: Baseline, Week 16

  6. Change From Baseline in Sleep-Loss Score

    Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicate a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary, and the week 16 score was calculated by averaging the daily scores from the previous 7 days and the average score was used to compute a change from baseline. MCMC-MI was used to handle missing data.

    Measured: Baseline, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start17 Nov 2020
  3. Primary completion3 Aug 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04626297
Sponsor's protocol ID
17946
Other IDs
J2T-MC-KGAK, 2020-002572-12
Status last verified
Oct 2023
First submitted
6 Nov 2020
Last updated
17 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Soung J, Laquer V, Merola JF, Moore A, Elmaraghy H, Hu C, Piruzeli MLB, Pierce E, Garcia Gil E, Jarell AD. The Impact of Lebrikizumab on Vaccine-Induced Immune Responses: Results from a Phase 3 Study in Adult Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Aug;14(8):2181-2193. doi: 10.1007/s13555-024-01217-w. Epub 2024 Jul 15.

    PubMed 39009804

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lebrikizumab in people with Atopic Dermatitis, run by Eli Lilly and Company at 85 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Develop a Booster Response to Tetanus Toxoid 4 Weeks After Tdap (Tetanus-diphtheria-pertussis) Vaccine Administration (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04626297, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in