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 (ADmirable)
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| ClinicalTrials.gov Identifier: NCT05372419 |
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Recruitment Status :
Recruiting
First Posted : May 12, 2022
Last Update Posted : April 16, 2024
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
- Study Details
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atopic Dermatitis | Drug: Lebrikizumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | January 12, 2023 |
| Estimated Primary Completion Date : | May 2024 |
| Estimated Study Completion Date : | December 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Atopic dermatitis
MedlinePlus related topics:
Eczema
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lebrikizumab
Participants will receive Lebrikizumab subcutaneously (SC).
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Drug: Lebrikizumab
Administered SC
Other Names:
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Primary Outcome Measures :
- Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% reduction from baseline in EASI) [ Time Frame: Baseline to Week 16 ]
Secondary Outcome Measures :
- Percentage of Participants Achieving a ≥75% Reduction from Baseline in EASI-75 [ Time Frame: Baseline to Week 24 ]
- Percentage of Participants with an Investigator's Global Assessment (IGA) score of 0 or 1 and a Reduction ≥2 Points from Baseline [ Time Frame: Baseline to Week 16 ]
- Percentage of Participants with an IGA score of 0 or 1 and a Reduction ≥2 Points from Baseline [ Time Frame: Baseline to Week 24 ]
- Percentage Change from Baseline in total EASI [ Time Frame: Baseline, Week 16 ]
- Percentage Change from Baseline in total EASI [ Time Frame: Baseline, Week 24 ]
- Change from Baseline in total EASI [ Time Frame: Baseline, Week 16 ]
- Change from Baseline in total EASI [ Time Frame: Baseline, Week 24 ]
- Percentage of Participants Achieving a ≥90% Reduction from Baseline in EASI-90 [ Time Frame: Baseline to Week 16 ]
- Percentage of Participants Achieving a ≥90% Reduction from Baseline in EASI-90 [ Time Frame: Baseline to Week 24 ]
- Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve a 4-point Reduction from Baseline [ Time Frame: Baseline to Week 16 ]
- Percentage of Participants with a Pruritus NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction from Baseline [ Time Frame: Baseline to Week 24 ]
- Percentage of Participants with a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction from Baseline [ Time Frame: Baseline to Week 16 ]
- Percentage of Participants with a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction from Baseline [ Time Frame: Baseline to Week 24 ]
- Percentage Change from Baseline in Pruritus NRS Score [ Time Frame: Baseline, Week 16 ]
- Percentage Change from Baseline in Pruritus NRS Score [ Time Frame: Baseline, Week 24 ]
- Percentage of Participants with a Sleep-Loss Scale Score of ≥2 points at Baseline Who Achieve a 2-point Reduction from Baseline [ Time Frame: Baseline to Week 16 ]
- Percentage of Participants with a Sleep-Loss Scale Score of ≥2 points at Baseline Who Achieve a 2-point Reduction from Baseline [ Time Frame: Baseline to Week 24 ]
- Percentage Change from Baseline in Sleep-Loss Scale Score [ Time Frame: Baseline, Week 16 ]
- Percentage Change from Baseline in Sleep-Loss Scale Score [ Time Frame: Baseline, Week 24 ]
- Percentage of Participants with a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction from Baseline [ Time Frame: Baseline to Week 16 ]
- Percentage of Participants with a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction from Baseline [ Time Frame: Baseline to Week 24 ]
- Change from Baseline in Patient-Oriented Eczema Measure (POEM) [ Time Frame: Baseline, Week 16 ]
- Change from Baseline in POEM [ Time Frame: Baseline, Week 24 ]
- Change from Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, Week 16 ]Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.
- Change from Baseline in DLQI [ Time Frame: Baseline, Week 24 ]Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.
- Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) [ Time Frame: Baseline, Week 16 ]Participants <16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study.
- Change from Baseline in cDLQI [ Time Frame: Baseline, Week 24 ]Participants <16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study
- Percentage of Participants with a DLQI of ≥4 points at Baseline Who Achieve a ≥4-point Improvement in DLQI [ Time Frame: Baseline to Week 16 ]Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.
- Percentage of Participants with a DLQI of ≥4 points at Baseline Who Achieve a ≥4-point Improvement in DLQI [ Time Frame: Baseline to Week 24 ]Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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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).
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Have uncontrolled asthma that
- might require bursts of oral or systemic corticosteroids, or
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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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05372419
Contacts
| Contact: There may be multiple sites in this clinical trial. : 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | ClinicalTrials.gov@lilly.com |
Locations
Show 47 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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) | Eli Lilly and Company |
Additional Information:
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT05372419 |
| Other Study ID Numbers: |
18500 J2T-MC-KGBP ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | May 12, 2022 Key Record Dates |
| Last Update Posted: | April 16, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting. |
| Access Criteria: | Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting. |
| URL: | http://vivli.org/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Eli Lilly and Company:
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Eczema |
Additional relevant MeSH terms:
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Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |