A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

Atopic Dermatitis Clinical Trial

— ADapt  

Official title:

An Open-Label, Study to Evaluate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05369403
• Other study ID #: 18499
• Secondary ID: J2T-MC-KGBO
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 19, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD) previously treated with Dupilumab.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• All participants must have prior treatment with dupilumab meeting one of the following conditions:

• Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab (at labeled dose level) for at least 4 months.

• Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment.

• Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment.

• Participants who have chronic AD that has been present for =1 year before screening.

• Have EASI =16 at baseline

• Have IGA score =3 (Scale of 0 to 4) at baseline

• Have =10% body surface area (BSA) of AD involvement at baseline

• Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.

• Adolescents body weight must be =40 kg at baseline.

Exclusion Criteria:

• History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.

• Have a current infection or chronic infection with hepatitis B virus (HBV) at screening (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA

• Have a current infection with hepatitis C virus (HCV) at screening (that is, positive for HCV RNA

• Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator.

• Have uncontrolled asthma that

• might require bursts of oral or systemic corticosteroids, or

• required the following due to =1 exacerbations within 12 months before baseline

• systemic (oral and/or parenteral) corticosteroid treatment, or

• hospitalization for >24 hours.

• Have known liver cirrhosis and/or chronic hepatitis of any etiology.

• Had Dupilumab treatment within 4 weeks prior to baseline

• Had prior treatment with tralokinumab.

• Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline

• Treatment with any of the following agents within 4 weeks prior to the baseline

• systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants)

• small molecules (e.g. JAK inhibitors)

• phototherapy and photochemotherapy for AD

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Lebrikizumab
Administered SC

Locations

Country	Name	City	State
United States	Oakland Hills Dermatology	Auburn Hills	Michigan
United States	Allcutis Research, Inc.	Beverly	Massachusetts
United States	Dermatologists of Greater Columbus	Bexley	Ohio
United States	Encore Medical Research of Boynton Beach	Boynton Beach	Florida
United States	Total Vein and Skin LLC	Boynton Beach	Florida
United States	The Derm Institute of West Michigan	Caledonia	Michigan
United States	Windsor Dermatology, P.C.	East Windsor	New Jersey
United States	Dermatology and Skin Surgery Center, PC	Exton	Pennsylvania
United States	UConn Health	Farmington	Connecticut
United States	First OC Dermatology	Fountain Valley	California
United States	Direct Helpers Research Center	Hialeah	Florida
United States	Hollywood Dermatology	Hollywood	Florida
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Axon Clinical Research	Inglewood	California
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Avance Clinical Trials Inc	Laguna Niguel	California
United States	Dermatology and Advanced Aesthetics	Lake Charles	Louisiana
United States	Dermatology Research Associates	Los Angeles	California
United States	Wallace Medical Group, Inc.	Los Angeles	California
United States	Skin Care Physicians of Georgia	Macon	Georgia
United States	Miami Dermatology and Laser Research	Miami	Florida
United States	River Region Dermatology and Laser	Montgomery	Alabama
United States	OptiSkin Medical	New York	New York
United States	Sadick Research Group	New York	New York
United States	Ziaderm Research, LLC.	North Miami Beach	Florida
United States	Medical Dermatology Specialists	Phoenix	Arizona
United States	Allcutis Research, Inc	Portsmouth	New Hampshire
United States	Dermatology and Skin Cancer Specialists, LLC	Rockville	Maryland
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Advanced Medical Research	Sandy Springs	Georgia
United States	Clinical Science Institute	Santa Monica	California
United States	Cura Clinical Research	Sherman Oaks	California
United States	Spokane Dermatology Clinic	Spokane	Washington
United States	Complete Dermatology	Sugar Land	Texas
United States	Olympian Clinical Research	Tampa	Florida
United States	Revival Research Institute - Troy	Troy	Michigan
United States	Dundee Dermatology	West Dundee	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) >75% Reduction in EASI Score		Baseline to Week 16
Secondary	Percentage of Participants Achieving EASI-75		Baseline to Week 24
Secondary	Percentage of Participants with an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction =2 Points from Baseline		Baseline to Week 16
Secondary	Percentage of Participants with an IGA Score of 0 or 1 and a Reduction =2 Points from Baseline		Baseline to Week 24
Secondary	Percentage Change from Baseline in EASI		Baseline, Week 16
Secondary	Percentage Change from Baseline in EASI		Baseline, Week 24
Secondary	Change from Baseline in EASI		Baseline, Week 16
Secondary	Change from Baseline in EASI		Baseline, Week 24
Secondary	Percentage of Participants Achieving EASI-90 (=90% Reduction in EASI Score) from Baseline		Baseline to Week 16
Secondary	Percentage of Participants Achieving EASI-90 from Baseline		Baseline to Week 24
Secondary	Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of =4 points at Baseline Who Achieve at least 4-point Reduction		Baseline to Week 16
Secondary	Percentage of Participants with a Pruritus NRS of =4 points at Baseline Who Achieve at least 4-point Reduction		Baseline to Week 24
Secondary	Percentage of Participants with a Pruritus NRS of =3 points at Baseline Who Achieve at least 3-point Reduction		Baseline to Week 16
Secondary	Percentage of Participants with a Pruritus NRS of =3 points at Baseline Who Achieve at least 3-point Reduction		Baseline to Week 24
Secondary	Percentage Change from Baseline in Pruritus NRS Score		Baseline, Week 16
Secondary	Percentage Change from Baseline in Pruritus NRS Score		Baseline, Week 24
Secondary	Percentage of Participants with a Sleep-Loss Scale of =2 points at Baseline Who Achieve at least 2-point Reduction		Baseline to Week 16
Secondary	Percentage of Participants with a Sleep-Loss Scale of =2 points at Baseline Who Achieve at least 2-point Reduction		Baseline to Week 24
Secondary	Change from Baseline in Sleep-Loss Scale		Baseline, Week 16
Secondary	Change from Baseline in Sleep-Loss Scale		Baseline, Week 24
Secondary	Change from Baseline in Skin Pain NRS		Baseline, Week 16
Secondary	Change from Baseline in Skin Pain NRS		Baseline, Week 24
Secondary	Change from Baseline in Dermatology Life Quality Index (DLQI)	Participants =16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.	Baseline, Week 16
Secondary	Change from Baseline in DLQI	Participants =16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.	Baseline, Week 24
Secondary	Change from Baseline in Children's Dermatology Life Quality Index (cDLQI)	Participants <16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study.	Baseline, Week 16
Secondary	Change from Baseline in cDLQI	Participants <16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study.	Baseline, Week 24
Secondary	Percentage Change from Baseline in SCORing Atopic Dermatitis (SCORAD)		Baseline, Week 16
Secondary	Percentage Change from Baseline in SCORAD		Baseline, Week 24

External Links

•   A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab