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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04392154
Ethics application status
Date submitted
13/05/2020
Date registered
18/05/2020

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

Experimental: Lebrikizumab Q2W (Open-Label) from Parent Study - Participants assigned to lebrikizumab Q2W (once every 2 weeks) arm will receive investigational product Q2W by subcutaneous (SC) injection.

Experimental: Lebrikizumab Q2W (Blinded) from Parent Study - Participants assigned to lebrikizumab Q2W arm will receive investigational product Q2W by SC injection. Some participants will receive loading doses.

Experimental: Lebrikizumab Q2W (Open-Label Addendum) - Participants enrolling in Open-Label Addendum will receive lebrikizumab Q2W by SC injection after loading doses.

Experimental: Lebrikizumab Q4W - Participants assigned to lebrikizumab Q4W (once every 4 weeks) arm will receive investigational product Q4W by SC injection.

Intervention assigned: Lebrikizumab balanced with Placebo to maintain the blind between treatment arms.

Experimental: Lebrikizumab Q4W (Open-Label Extension Addendum) - Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q4W by SC injection.

Experimental: Lebrikizumab Q8W (Open-Label Extension Addendum) - Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q8W by SC injection.

Experimental: Lebrikizumab Q2W (Open-Label Extension Addendum) - Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q2W by SC injection.


Treatment: Other: Lebrikizumab
Subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Discontinued from Study Treatment due to Adverse Events through the Last Treatment Visit
Timepoint [1] 0 0
Baseline to Week 100
Secondary outcome [1] 0 0
Percentage of Participants with a Response of Investigator Global Assessment (IGA) Score 0 or 1
Timepoint [1] 0 0
Baseline to Week 100
Secondary outcome [2] 0 0
Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) from Baseline of Parent Study
Timepoint [2] 0 0
Baseline to Week 100

Eligibility
Key inclusion criteria
Inclusion Criteria for participants coming from a parent study:

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

* 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.
* 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for participants coming from a parent study:

Participants meeting any of the criteria below will not be included in this study:

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

Open-Label Addendum Inclusion Criteria:

Participants must meet all the following criteria to be eligible for this study addendum:

* Male or female adults and adolescents (=12 to <18 years of age and weighing =40 kilogram (kg).
* Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for =1 year before screening.
* Eczema Area and Severity Index (EASI) score =16 at baseline.
* Investigator Global Assessment (IGA) score =3 (scale of 0 to 4) at baseline.
* =10% body surface area (BSA) of AD involvement at baseline.
* History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.

Open-Label Addendum

Participants meeting any of the criteria below will be excluded from this study addendum:

* Have received a dose of lebrikizumab in any prior lebrikizumab clinical study.
* History of anaphylaxis
* Treatment with topical prescription moisturizers, corticosteroids, calcineurin inhibitors, or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to baseline.
* Treatment with any of the following agents within 4 weeks prior to the baseline.

* Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon gamma (IFN-?), Janus kinase inhibitors, azathioprine, methotrexate, etc.)
* Phototherapy and photochemotherapy (PUVA) for AD.
* Treatment with the following prior to baseline:

* Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-?, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
* Phototherapy and photochemotherapy (PUVA) for AD.
* Treatment with the following prior to baseline:

* An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
* B Cell-depleting biologics, including rituximab, within 6 months.
* Other Biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
* Regular use (more than 2 uses per week) of a tanning booth/parlor within 4 weeks of baseline.
* Treatment with a live (attenuated) vaccine within 12 weeks of the baseline or planned during the study.
* Uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma, (as defined by the investigator).
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
* Evidence of active acute or chronic hepatitis
* History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
* History of malignancy, including mycosis fungoides, within 5 years before screening, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.

Open-Label Extension Addendum Inclusion Criteria:

Have completed Week 100 of Study KGAA and have not yet completed the safety follow-up visit for the main study.

Open-Label Extension Addendum

Have initiated treatment with a medication prohibited by Study KGAA before addendum baseline. This includes use of biologics for AD (for example, dupilumab and tralokinumab) during the safety follow-up period of Study KGAA.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/04/2025
Actual
Sample size
Target
Accrual to date
Final
1188
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
The Skin Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Premier Specialists Pty Ltd - Kogarah
Recruitment hospital [4] 0 0
The St. George Hospital - Kogarah
Recruitment hospital [5] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [6] 0 0
Skin & Cancer Foundation Australia - Westmead
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
The Skin Centre - Benowa
Recruitment hospital [9] 0 0
University of the Sunshine Coast Clinical Trial Centre - Sippy Downs
Recruitment hospital [10] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [11] 0 0
Clinical Trials SA Pty Ltd - Hectorville
Recruitment hospital [12] 0 0
Emeritus Research - Camberwell
Recruitment hospital [13] 0 0
Skin Health Institute Inc. - Carlton
Recruitment hospital [14] 0 0
Sinclair Dermatology - Melbourne
Recruitment hospital [15] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [16] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [17] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [18] 0 0
Burswood Dermatology - Victoria Park
Recruitment hospital [19] 0 0
Captain Stirling Medical Centre - Nedlands
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
02010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2010 - Sydney
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2045 - Westmead
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
4217 - Benowa
Recruitment postcode(s) [8] 0 0
04556 - Sippy Downs
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
5073 - Hectorville
Recruitment postcode(s) [11] 0 0
3124 - Camberwell
Recruitment postcode(s) [12] 0 0
3053 - Carlton
Recruitment postcode(s) [13] 0 0
3002 - Melbourne
Recruitment postcode(s) [14] 0 0
03050 - Parkville
Recruitment postcode(s) [15] 0 0
3052 - Parkville
Recruitment postcode(s) [16] 0 0
6160 - Fremantle
Recruitment postcode(s) [17] 0 0
06100 - Victoria Park
Recruitment postcode(s) [18] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Singapore
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Catalunya [Cataluña]
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Alicante
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Barcelona
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Bilbao (Bizkaia)
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Madrid
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Sevilla
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Kaohsiung
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Taichung
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Taipei
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Taiwan
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Taoyuan City
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Ukraine
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Zaporizhzhya
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Ukraine
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Kharkiv
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Ukraine
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Rivne
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Ukraine
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Uzhhorod

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Dermira, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04392154