A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color

Atopic Dermatitis Clinical Trial

— ADmirable  

Official title:

An Open-Label, 24-Week Study to Investigate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05372419
• Other study ID #: 18500
• Secondary ID: J2T-MC-KGBP
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 12, 2023
• Est. completion date: December 2024

Study information

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

Clinical Trial Summary

The main purpose of this study is to determine the safety and efficacy lebrikizumab in adolescent and adult participants with moderate-to-severe atopic dermatitis (AD) and skin of color.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: May 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

Participants must be =12 years of age inclusive, at the time of signing the informed consent/assent.

• Participants who are self-reported race other than White, including but not limited to persons who self-identify as Black or African American, American Indian or Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander.

• Participants who are Fitzpatrick phototype IV-VI

• 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.

• Are willing and able to comply with all clinic visits and study-related procedures and questionnaires.

• Contraceptive use - Male and/or female

• Male participants are not required to use any contraception except in compliance with specific local government study requirements.

• Female participants of child-bearing 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-child-bearing potential (non-WOCBP) may participate without any contraception requirements.

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 (HBsAg) 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 prior treatment with dupilumab

• Had prior treatment with tralokinumab

• Treatment with topical agents (corticosteroids, calcineurin inhibitors, JAK inhibitors, or phosphodiesterase-4 inhibitors) within 2 weeks prior to baseline.

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

• systemic immunosuppressive/immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants);

• small molecules (for example, Janus Kinase (JAK) inhibitors);

• phototherapy and photochemotherapy for AD.

• History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Lebrikizumab
Administered SC

Locations

Country	Name	City	State
United States	Arlington Research Center, Inc	Arlington	Texas
United States	Oakland Hills Dermatology	Auburn Hills	Michigan
United States	Allcutis Research, Inc.	Beverly	Massachusetts
United States	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama
United States	Encore Medical Research of Boynton Beach	Boynton Beach	Florida
United States	Dermatology & Laser Center of Charleston	Charleston	South Carolina
United States	UConn Health	Farmington	Connecticut
United States	First OC Dermatology	Fountain Valley	California
United States	Center For Dermatology Clinical Research, Inc.	Fremont	California
United States	Skin Care Research, Inc	Hollywood	Florida
United States	Clinical Trial Network	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Axon Clinical Research	Inglewood	California
United States	Solutions Through Advanced Research	Jacksonville	Florida
United States	Avance Clinical Trials Inc	Laguna Niguel	California
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	Savin Medical Group, LLC	Miami Lakes	Florida
United States	Sadick Research Group	New York	New York
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Skin Specialists, P.C	Omaha	Nebraska
United States	PureSkin Dermatology	Orlando	Florida
United States	Cura Clinical Research	Palmdale	California
United States	University of California Davis (UC Davis) Comprehensive Cancer Center	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Progressive Clinical Research	San Antonio	Texas
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
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	Complete Dermatology	Sugar Land	Texas
United States	Revival Research Institute - Troy	Troy	Michigan
United States	Wilmington Health Family Medicine	Wilmington	North Carolina

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 from baseline in EASI)		Baseline to Week 16
Secondary	Percentage of Participants Achieving a =75% Reduction from Baseline in 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 total EASI		Baseline, Week 16
Secondary	Percentage Change from Baseline in total EASI		Baseline, Week 24
Secondary	Change from Baseline in total EASI		Baseline, Week 16
Secondary	Change from Baseline in total EASI		Baseline, Week 24
Secondary	Percentage of Participants Achieving a =90% Reduction from Baseline in EASI-90		Baseline to Week 16
Secondary	Percentage of Participants Achieving a =90% Reduction from Baseline in EASI-90		Baseline to Week 24
Secondary	Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of =4 Points at Baseline Who Achieve a 4-point Reduction from Baseline		Baseline to Week 16
Secondary	Percentage of Participants with a Pruritus NRS of =4 Points at Baseline Who Achieve a 4-point Reduction from Baseline		Baseline to Week 24
Secondary	Percentage of Participants with a Pruritus NRS =3 Points at Baseline Who Achieve at Least 3- Point Reduction from Baseline		Baseline to Week 16
Secondary	Percentage of Participants with a Pruritus NRS =3 Points at Baseline Who Achieve at Least 3- Point Reduction from Baseline		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 Score of =2 points at Baseline Who Achieve a 2-point Reduction from Baseline		Baseline to Week 16
Secondary	Percentage of Participants with a Sleep-Loss Scale Score of =2 points at Baseline Who Achieve a 2-point Reduction from Baseline		Baseline to Week 24
Secondary	Percentage Change from Baseline in Sleep-Loss Scale Score		Baseline, Week 16
Secondary	Percentage Change from Baseline in Sleep-Loss Scale Score		Baseline, Week 24
Secondary	Percentage of Participants with a Skin Pain NRS of =4 Points at Baseline Who Achieve a 4-point Reduction from Baseline		Baseline to Week 16
Secondary	Percentage of Participants with a Skin Pain NRS of =4 Points at Baseline Who Achieve a 4-point Reduction from Baseline		Baseline to Week 24
Secondary	Change from Baseline in Patient-Oriented Eczema Measure (POEM)		Baseline, Week 16
Secondary	Change from Baseline in POEM		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 of Participants with a DLQI of =4 points at Baseline Who Achieve a =4-point Improvement in DLQI	Participants =16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.	Baseline to Week 16
Secondary	Percentage of Participants with a DLQI of =4 points at Baseline Who Achieve a =4-point Improvement in DLQI	Participants =16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.	Baseline to Week 24

External Links

•   A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color