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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06015737




Registration number
NCT06015737
Ethics application status
Date submitted
1/08/2023
Date registered
29/08/2023

Titles & IDs
Public title
A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
Scientific title
A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus Who Are Refractory and/or Intolerant to Antimalarial Therapy
Secondary ID [1] 0 0
2021-003698-70
Secondary ID [2] 0 0
D346BC00001
Universal Trial Number (UTN)
Trial acronym
LAVENDER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

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

Experimental: Stage 1: Anifrolumab - The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.

Placebo comparator: Stage 1: Placebo - The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.

Experimental: Stage 2: Anifrolumab - The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.

Placebo comparator: Stage 2: Placebo - The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.


Other interventions: Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).

Other interventions: Placebo
Matching placebo solution for injection in aPFS.

Other interventions: Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).

Other interventions: Placebo
Matching placebo solution for injection in aPFS.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stage 1 and Stage 2 (United States [US]): Number of participants with Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R) erythema score of 0 or 1 and at least a 2- point reduction relative to baseline
Timepoint [1] 0 0
At Week 24
Primary outcome [2] 0 0
Stage 1 and Stage 2 (European Union [EU]/Rest of the World [ROW]: Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score
Timepoint [2] 0 0
At Week 24
Secondary outcome [1] 0 0
Stage 1 and Stage 2 (US): Number of participants who achieve a CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline
Timepoint [1] 0 0
At Week 24
Secondary outcome [2] 0 0
Stage 1 and Stage 2 (US): Number of participants who achieve a CLA-IGA-R OMC score of 0.
Timepoint [2] 0 0
At Week 24
Secondary outcome [3] 0 0
Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R follicular activity score of 0
Timepoint [3] 0 0
At Week 24
Secondary outcome [4] 0 0
Stage 1 and Stage 2 (EU/ROW): Percent change from baseline in total CLASI-A erythema score
Timepoint [4] 0 0
At Week 24
Secondary outcome [5] 0 0
Stage 1 and Stage 2 (EU/ROW): Percent change from baseline in total CLASI-A scale/hypertrophy score
Timepoint [5] 0 0
At Week 24
Secondary outcome [6] 0 0
Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline, or a CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline
Timepoint [6] 0 0
At Week 24
Secondary outcome [7] 0 0
Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline
Timepoint [7] 0 0
At Week 12
Secondary outcome [8] 0 0
Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline
Timepoint [8] 0 0
At Week 12
Secondary outcome [9] 0 0
Stage 1 and Stage 2 (EU/ROW): Number of participants with CLASI-70 response
Timepoint [9] 0 0
At Week 12
Secondary outcome [10] 0 0
Stage 1 and Stage 2 (US/EU/ROW): Change from baseline in Skindex-29+3 domain scores
Timepoint [10] 0 0
At Week 24
Secondary outcome [11] 0 0
Stage 1 and Stage 2 (US/EU/ROW): Serum trough (pre-dose) concentrations of anifrolumab
Timepoint [11] 0 0
Double-blind: Pre-dose on Day 1 (Week 0), Weeks 1, 4, 12, 24; Open-label: Weeks 40, and 52 or early discontinuation visit [EDV] and follow-up visit (13 Weeks after last dose)
Secondary outcome [12] 0 0
Stage 1 and Stage 2 (US/EU/ROW): Number of participants with positive antidrug antibody
Timepoint [12] 0 0
Double-blind: Pre-dose on Day 1 (Week 0), Weeks 4, 12, and 24; Open-label: Pre-dose on Weeks 40, and 52 or EDV and follow-up visit (13 weeks after last dose)
Secondary outcome [13] 0 0
Stage 1 and Stage 2 (US/EU/ROW): Percent change from baseline in suppression of the Interferon 21-gene
Timepoint [13] 0 0
Double-blind: Day 1 (Week 0), Week 1, 4, 12, and 24; Open-label; Week 40 and 52 or EDV and follow-up visit (13 weeks after last dose)
Secondary outcome [14] 0 0
Stage 2 (US/EU/ROW): Number of participants with = 7-point reduction from baseline in CLASI-A total score
Timepoint [14] 0 0
At Week 24
Secondary outcome [15] 0 0
Stage 2 (US): Number of participants who are CLA-IGA-R erythema responders from Week 24 up to and including Week 52
Timepoint [15] 0 0
Up to Week 52
Secondary outcome [16] 0 0
Stage 2 (EU): Number of participants who are CLASI-70 responders up to and including Week 52
Timepoint [16] 0 0
Up to Week 52

Eligibility
Key inclusion criteria
Key inclusion criteria:

* Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:

* CLASI-A total score = 10 points at Screening and confirmed at randomization.
* CLA-IGA-R erythema score of = 3 and CLA-IGA-R-OMC score of = 1 at Screening and confirmed at randomization.
* Inadequate response or intolerant to antimalarial therapy.
* Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.
* Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.

Key exclusion criteria:

* History or evidence of suicidal ideation.
* Severe or life-threatening Systemic lupus erythematosus (SLE).
* Active SLE or Sjögren's Syndrome.
* Any active skin conditions other than CLE that may interfere with the study.
* History of recurrent infection requiring hospitalization and IV antibiotics.
* COVID-19 infection
* Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
* At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.

NOTE: Other protocol defined Inclusion/
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria may apply

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 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
29/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/12/2027
Actual
Sample size
Target
460
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Clayton
Recruitment hospital [3] 0 0
Research Site - Kogarah
Recruitment hospital [4] 0 0
Research Site - Malvern
Recruitment hospital [5] 0 0
Research Site - Melbourne
Recruitment hospital [6] 0 0
Research Site - Westmead
Recruitment hospital [7] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3168 - Kogarah
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
04102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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California
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Quilmes
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Portugal
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Coimbra
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Romania
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Iasi
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Belgrade
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Serbia
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Kragujevac
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Piestany
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Slovakia
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Svidnik
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South Africa
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Cape Town
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South Africa
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Johannesburg
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Barcelona
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Granada
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La Coruña
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Las Palmas de Gran Canaria
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Madrid
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Salamanca
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Sevilla
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Valencia
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Spain
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València
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Spain
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Vigo
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Hat Yai
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Thailand
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Khon-Kaen
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Turkey
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Istanbul
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Turkey
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Kayseri
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United Kingdom
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Cambridge
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United Kingdom
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Leeds
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
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?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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/NCT06015737