Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04250350
Registration number
NCT04250350
Ethics application status
Date submitted
30/01/2020
Date registered
31/01/2020
Titles & IDs
Public title
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
Query!
Scientific title
An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
Query!
Secondary ID [1]
0
0
J2T-DM-KGAE
Query!
Secondary ID [2]
0
0
17804
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ADore
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Lebrikizumab
Experimental: Lebrikizumab 250 mg - Participants received two subcutaneous (SC) injections of 250 milligram(mg) Lebrikizumab at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 up to (but not including) Week 52.
Treatment: Other: Lebrikizumab
Subcutaneous injection
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 52
Query!
Secondary outcome [1]
0
0
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction =2-points From Baseline
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 52
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving =75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 52
Query!
Secondary outcome [3]
0
0
Percentage Change From Baseline in EASI Score
Query!
Assessment method [3]
0
0
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).
Query!
Timepoint [3]
0
0
Baseline, Week 52
Query!
Secondary outcome [4]
0
0
Percentage of Participants Achieving EASI-50 (=50 Reduction From Baseline in EASI Score)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Week 52
Query!
Secondary outcome [5]
0
0
Percentage of Participants Achieving EASI-90 (=90% Reduction From Baseline in EASI Score)
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Week 52
Query!
Secondary outcome [6]
0
0
Change From Baseline in Body Surface Area (BSA)
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline, Week 52
Query!
Secondary outcome [7]
0
0
Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline, Week 52
Query!
Secondary outcome [8]
0
0
Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Depression
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline, Week 52
Query!
Secondary outcome [9]
0
0
Change From Baseline in Dermatology Life Quality Index (DLQI)
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline, Week 52
Query!
Secondary outcome [10]
0
0
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
Query!
Assessment method [10]
0
0
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).
Query!
Timepoint [10]
0
0
Baseline, Week 52
Query!
Secondary outcome [11]
0
0
Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab
Query!
Assessment method [11]
0
0
Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab was evaluated at Week 52.
Query!
Timepoint [11]
0
0
Predose: Week 52
Query!
Eligibility
Key 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.
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/02/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
22/06/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
206
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Woden Dermatology - Phillip
Query!
Recruitment hospital [2]
0
0
The Skin Hospital - Sydney
Query!
Recruitment hospital [3]
0
0
The Skin Centre - Benowa
Query!
Recruitment hospital [4]
0
0
Veracity Clinical Research Pty Ltd - Woolloongabba
Query!
Recruitment hospital [5]
0
0
Sinclair Dermatology - East Melbourne
Query!
Recruitment hospital [6]
0
0
Royal Childrens Hospital Melbourne - Parkville
Query!
Recruitment hospital [7]
0
0
Burswood Dermatology - Victoria Park
Query!
Recruitment hospital [8]
0
0
Captain Stirling Medical Centre - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2606 - Phillip
Query!
Recruitment postcode(s) [2]
0
0
02010 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
4217 - Benowa
Query!
Recruitment postcode(s) [4]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [5]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [6]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [7]
0
0
06100 - Victoria Park
Query!
Recruitment postcode(s) [8]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Hampshire
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Ohio
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Oklahoma
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Pennsylvania
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Virginia
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Alberta
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Ontario
Query!
Country [24]
0
0
Poland
Query!
State/province [24]
0
0
Lodzkie
Query!
Country [25]
0
0
Poland
Query!
State/province [25]
0
0
Malopolskie
Query!
Country [26]
0
0
Poland
Query!
State/province [26]
0
0
Mazowieckie
Query!
Country [27]
0
0
Poland
Query!
State/province [27]
0
0
Swietokrzyskie
Query!
Country [28]
0
0
Poland
Query!
State/province [28]
0
0
Wojewodztwo Podkarpackie
Query!
Country [29]
0
0
Poland
Query!
State/province [29]
0
0
Katowice
Query!
Country [30]
0
0
Poland
Query!
State/province [30]
0
0
Lublin
Query!
Country [31]
0
0
Poland
Query!
State/province [31]
0
0
Wroclaw
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Dermira, Inc.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04250350
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
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)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Query!
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/50/NCT04250350/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/50/NCT04250350/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04250350