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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04392154




Registration number
NCT04392154
Ethics application status
Date submitted
13/05/2020
Date registered
18/05/2020
Date last updated
19/11/2020

Titles & IDs
Public title
Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
Scientific title
A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis
Secondary ID [1] 0 0
2020-001211-24
Secondary ID [2] 0 0
17789
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Lebrikizumab

Experimental: Lebrikizumab Q2W - Participants randomized to Lebrikizumab Q2W arm will receive investigational product on a once every 2 week schedule.

Experimental: Lebrikizumab Q4W - Participants randomized to Lebrikizumab Q4W arm will receive investigational product on a once every 4 week schedule.
Intervention assigned: Lebrikizumab balanced with Placebo to maintain the blind between treatment arms.


Other interventions: Lebrikizumab
Subcutaneous injection

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants discontinued from study treatment due to adverse events through the last treatment visit.
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
Proportion of participants with a response of IGA 0 or 1
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
Proportion of participants achieving response of EASI-75 from baseline of parent study.
Timepoint [2] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
Participants must meet all the following criteria to be eligible for this study:

1. Received treatment in a lebrikizumab study, NCT04146363, NCT04178967, NCT04250337,
NCT04250350 and have adequately completed the study treatments and last patient visit
of the parent trial.

2. Willing and able to comply with all clinic visits and study-related procedures.

3. For women of childbearing potential: 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 lebrikizumab or
placebo.

NOTE: A woman of childbearing potential (WOCBP) is defined as a postmenarcheal female,
who has not reached a postmenopausal state (=12 continuous months of amenorrhea with
no identified cause other than menopause) and has not undergone surgical sterilization
(removal of ovaries and/or uterus).

NOTE: The following are highly effective contraceptive methods: combined (estrogen and
progestogen containing) hormonal contraception (oral, intravaginal, transdermal)
associated with inhibition of ovulation, progestogen-only hormonal contraception
(oral, injectable, implantable) associated with inhibition of ovulation, intrauterine
device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion,
vasectomized partner, or sexual abstinence. The reliability of sexual abstinence
should be evaluated in relation to the duration of the clinical trial and the
preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar,
ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable
methods of contraception.

4. Male participants must agree to use an effective barrier method of contraception
during the study and for a minimum of 18 weeks following the last dose of study drug
if sexually active with a female of child-bearing potential.

5. Provide signed informed consent/assent.
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants meeting any of the criteria below will not be included in this study:

1. Participants who, during their participation in the parent trial, developed a serious
adverse event (SAE) deemed related to lebrikizumab, which in the opinion of the
investigator or of the medical monitor could indicate that continued treatment with
lebrikizumab may present an unreasonable risk for the participant. *

2. Participants who, during their participation in the parent trial, developed an AE that
was deemed related to lebrikizumab and led to study treatment discontinuation, which
in the opinion of the investigator or of the medical monitor could indicate that
continued treatment with lebrikizumab may present an unreasonable risk for the
participant. *

3. Conditions in the previous parent study consistent with protocol-defined criteria for
permanent study drug discontinuation, if deemed related to lebrikizumab or led to
investigator - or sponsor-initiated withdrawal of participant from the study (e.g.,
non-compliance, inability to complete study assessments, etc.). *

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

Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions
deemed related to the study treatment will be considered related to lebrikizumab.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
Premier Specialists Pty Ltd - Kogarah
Recruitment hospital [3] 0 0
The St. George Hospital - Kogarah
Recruitment hospital [4] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
The Skin Centre - Benowa
Recruitment hospital [7] 0 0
University of the Sunshine Coast Clinical Trial Centre - Sippy Downs
Recruitment hospital [8] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [9] 0 0
Clinical Trials SA Pty Ltd - Hectorville
Recruitment hospital [10] 0 0
Emeritus Research - Camberwell
Recruitment hospital [11] 0 0
Skin Health Institute Inc. - Carlton
Recruitment hospital [12] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [13] 0 0
Royal Childrens Hospital Melbourne - Parkville
Recruitment hospital [14] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [15] 0 0
Burswood Dermatology - Victoria Park
Recruitment hospital [16] 0 0
Sinclair Dermatology - Victoria
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4217 - Benowa
Recruitment postcode(s) [6] 0 0
04556 - Sippy Downs
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5073 - Hectorville
Recruitment postcode(s) [9] 0 0
3124 - Camberwell
Recruitment postcode(s) [10] 0 0
3053 - Carlton
Recruitment postcode(s) [11] 0 0
03050 - Parkville
Recruitment postcode(s) [12] 0 0
3052 - Parkville
Recruitment postcode(s) [13] 0 0
6160 - Fremantle
Recruitment postcode(s) [14] 0 0
06100 - Victoria Park
Recruitment postcode(s) [15] 0 0
3002 - Victoria
Recruitment outside Australia
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Cluj
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Ukraine
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Kharkiv
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Rivne
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Uzhhorod
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Ukraine
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Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Dermira, Inc. a wholly owned subsidiary of Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52
weeks in duration. The study is designed to evaluate the long-term safety and efficacy of
lebrikizumab in participants with moderate-to-severe atopic dermatitis.
Trial website
https://clinicaltrials.gov/show/NCT04392154
Trial related presentations / publications
Public notes

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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
clinicaltrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04392154