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

Atopic Dermatitis Clinical Trial

— ADore  

Official title:

An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04250350
• Other study ID #: 17804
• Secondary ID: J2T-DM-KGAEDRM06
• Status: Completed
• Phase: Phase 3
• Start date: February 11, 2020
• Est. completion date: June 22, 2022

Study information

• Verified date: January 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to <18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 22, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Male or female adolescent (=12 years to <18 years, and weighing =40 kg).

2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for =1 year before the screening visit.

3. Eczema Area and Severity Index (EASI) score =16 at the baseline visit.

4. Investigator Global Assessment (IGA) score =3 (scale of 0 to 4) at the baseline visit

5. =10% body surface area (BSA) of AD involvement at the baseline visit.

6. History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.

Exclusion Criteria:

1. Participation in a prior lebrikizumab clinical study.

2. Treatment with the following prior to the baseline visit:

1. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.

2. Dupilumab within 8 weeks.

3. B-cell-depleting biologics, including to rituximab, within 6 months.

4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.

3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.

4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.

5. Evidence of active acute or chronic hepatitis

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

7. History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Biological:
• Lebrikizumab
Subcutaneous injection

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
Australia	Sinclair Dermatology	East Melbourne	Victoria
Australia	Captain Stirling Medical Centre	Nedlands
Australia	Royal Childrens Hospital Melbourne	Parkville	Victoria
Australia	Woden Dermatology	Phillip	Australian Capital Territory
Australia	The Skin Hospital	Sydney	New South Wales
Australia	Burswood Dermatology	Victoria Park	Western Australia
Australia	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland
Canada	Institute for Skin Advancement	Calgary	Alberta
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	The Centre for Clinical Trials, Inc	Oakville	Ontario
Canada	CARe Clinic	Red Deer	Alberta
Canada	AvantDerm	Toronto	Ontario
Poland	Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.	Iwonicz Zdroj	Wojewodztwo Podkarpackie
Poland	Provita Sp. z o.o	Katowice
Poland	Gabinet Dermatlogiczny. Beata Krecisz	Kielce	Swietokrzyskie
Poland	Diamond Clinic	Krakow	Malopolskie
Poland	Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"	Krakow	Malopolskie
Poland	Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Lodzkie
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie	Lublin
Poland	Centrum Medyczne Evimed	Warszawa	Mazowieckie
Poland	CityClinic Przychodnia Lekarsko-Psychologiczna	Wroclaw
United States	Georgia Pollens Clinical Research Centers, Inc	Albany	Georgia
United States	Pinnacle Research Group	Anniston	Alabama
United States	Arlington Research Center, Inc	Arlington	Texas
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	PI-Coor Clinical Research, LLC	Burke	Virginia
United States	Hope Clinical Research	Canoga Park	California
United States	IMMUNOe International Research Centers	Centennial	Colorado
United States	Northwestern University	Chicago	Illinois
United States	C&R Research Services USA	Coral Gables	Florida
United States	Florida Academic Centers Research and Education, LLC	Coral Gables	Florida
United States	Pediatric Skin Research, LLC	Coral Gables	Florida
United States	Ohio Pediatric Research Association	Dayton	Ohio
United States	First OC Dermatology	Fountain Valley	California
United States	MD Studies	Fountain Valley	California
United States	Encore Medical Research	Hollywood	Florida
United States	Encore Imaging & Medical Research	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Solutions Through Advanced Research, Inc.	Jacksonville	Florida
United States	Forest Hills Dermatology Group	Kew Gardens	New York
United States	Cutis Wellness Dermatology	Laredo	Texas
United States	Skin Sciences, PLLC	Louisville	Kentucky
United States	Miami Dermatology and Laser Research	Miami	Florida
United States	Sanchez Clinical Research Inc	Miami	Florida
United States	Well Pharma Medical Research Corp.	Miami	Florida
United States	Tulane Univ School of Med	New Orleans	Louisiana
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Sneeze, Wheeze, & Itch Associates LLC	Normal	Illinois
United States	Arkansas Research Trials, LLC	North Little Rock	Arkansas
United States	Park Avenue Dermatology	Orange Park	Florida
United States	Paddington Testing Company Inc	Philadelphia	Pennsylvania
United States	ALLCUTIS Research	Portsmouth	New Hampshire
United States	Dermatology and Skin Cancer Specialists	Rockville	Maryland
United States	Integrative Skin Science and Research	Sacramento	California
United States	St Joseph Dermatology and Vein Clinic	Saint Joseph	Michigan
United States	Central Dermatology PC	Saint Louis	Missouri
United States	Progressive Clinical Research	San Antonio	Texas
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology	San Diego	California
United States	Advanced Medical Research	Sandy Springs	Georgia
United States	Southern California Dermatology, Inc.	Santa Ana	California
United States	Georgia Skin & Cancer Clinic	Savannah	Georgia
United States	Acclaim Dermatology, PLLC	Sugar Land	Texas
United States	ForCare Clinical Research	Tampa	Florida
United States	Kansas Medical Clinic	Topeka	Kansas
United States	Central States Research	Tulsa	Oklahoma
United States	Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma
United States	Advanced Asthma and Allergy	Watertown	New York
United States	Center for Clinical Studies	Webster	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Dermira, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs)	The percentage of participants who discontinued from study treatment due to 1 or more AEs assessed is summarized cumulatively. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.	Week 52
Secondary	Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction =2-points From Baseline	The IGA measures the investigator's global assessment of the participant's overall severity of their 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.	Week 52
Secondary	Percentage of Participants Achieving =75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75)	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs 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: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).; The EASI responder is defined as a participant who achieves a = 75% improvement from baseline in the EASI score.	Week 52
Secondary	Percentage Change From Baseline in EASI Score	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs 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: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).	Baseline, Week 52
Secondary	Percentage of Participants Achieving EASI-50 (=50 Reduction From Baseline in EASI Score)	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs 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: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).; The EASI responder is defined as a participant who achieves a = 50% improvement from baseline in the EASI score.	Week 52
Secondary	Percentage of Participants Achieving EASI-90 (=90% Reduction From Baseline in EASI Score)	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs 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: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).; The EASI responder is defined as a participant who achieves a = 90% improvement from baseline in the EASI score.	Week 52
Secondary	Change From Baseline in Body Surface Area (BSA)	The BSA affected by AD will be assessed for 4 separate 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% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.	Baseline, Week 52
Secondary	Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety	PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants =17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety.	Baseline, Week 52
Secondary	Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Depression	PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Questions are measured on a 5-point scale with 1 being "Never" and 5 being "Always". Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service, which rescales the raw score to a standardized T-Score with a population mean of 50 and a standard deviation of 10. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms.	Baseline, Week 52
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI)	The DLQI questionnaire designed for participants aged 17 years or more is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.	Baseline, Week 52
Secondary	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)	The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment).	Baseline, Week 52
Secondary	Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab	Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab was evaluated at Week 52.	Predose: Week 52

External Links

•   Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis (ADore)