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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04781816




Registration number
NCT04781816
Ethics application status
Date submitted
28/02/2021
Date registered
4/03/2021

Titles & IDs
Public title
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
Scientific title
Randomized, Double-blind, Placebo Controlled, Proof of Concept Study Assessing the Efficacy and Safety of the RIPK1-inhibitor SAR443122 in Patients With Moderate to Severe Subacute or Discoid/Chronic Cutaneous Lupus Erythematosus
Secondary ID [1] 0 0
U1111-1246-6784
Secondary ID [2] 0 0
ACT16404
Universal Trial Number (UTN)
Trial acronym
CLEan
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
Treatment: Drugs - SAR443122
Treatment: Drugs - Placebo

Experimental: SAR443122 - SAR443122 for 12 weeks

Placebo comparator: Placebo - Matching placebo


Treatment: Drugs: SAR443122
Pharmaceutical form: Capsule Route of administration: Oral

Treatment: Drugs: Placebo
Pharmaceutical form: Capsule Route of administration: Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12
Timepoint [1] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [1] 0 0
Percentage of Participants With Physician's Global Assessment of Disease Activity (PhysGA- Disease Activity) of 0 or 1 (Disease Free or Almost Disease Free) at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Change From Baseline in Participants Reported Daily Worst Itch Using Peak Pruritus Numerical Rating Scale (Itch-NRS) at Week 12
Timepoint [2] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [3] 0 0
Change From Baseline in Participants Reported Daily Worst Pain Using Peak Pain Numerical Rating Scale (Pain-NRS) at Week 12
Timepoint [3] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [4] 0 0
Percentage of CLASI-A50 and CLASI-A75 Responders at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Change From Baseline in CLASI Components' Score Over Time
Timepoint [5] 0 0
Baseline (Day 1) and Weeks 4, 8, 12, and 16
Secondary outcome [6] 0 0
Percentage of Participants With Investigator's Global Assessment of Cutaneous Lupus Erythematosus (IGA-CLE) Score of 0 or 1 (Clear Or Almost Clear) at Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Change From Baseline to Week 12 in the Oral Health Impact Profile 14-Item Version (OHIP-14) for Participants With Oral Lesions at Baseline
Timepoint [7] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [8] 0 0
Change From Baseline in SKINDEX-29+3 Total Score at Week 12
Timepoint [8] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [9] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESIs)
Timepoint [9] 0 0
From first dose of study treatment (Day 1) up to end of study (Week 16)
Secondary outcome [10] 0 0
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Timepoint [10] 0 0
From first dose of study treatment (Day 1) up to end of study (Week 16)
Secondary outcome [11] 0 0
Number of Participants With PCSA in Clinical Chemistry
Timepoint [11] 0 0
From first dose of study treatment (Day 1) up to end of study (Week 16)
Secondary outcome [12] 0 0
Number of Participants With PCSA in Urinalysis
Timepoint [12] 0 0
From first dose of study treatment (Day 1) up to end of study (Week 16)
Secondary outcome [13] 0 0
Number of Participants With PCSA in Electrocardiogram (ECG)
Timepoint [13] 0 0
From first dose of study treatment (Day 1) up to end of study (Week 16)
Secondary outcome [14] 0 0
Number of Participants With PCSA in Vital Signs
Timepoint [14] 0 0
From first dose of study treatment (Day 1) up to end of study (Week 16)
Secondary outcome [15] 0 0
Maximum Plasma Concentration (Cmax) of SAR443122
Timepoint [15] 0 0
2-5 hours post first morning dose on Days 1, 57, and 85; 1 hour before morning dose on Days 57 and 85; 7-10 hours after morning dose on Day 57
Secondary outcome [16] 0 0
Time to Reach Maximum Plasma Concentration (Tmax) of SAR443122
Timepoint [16] 0 0
2-5 hours post first morning dose on Days 1, 57, and 85; 1 hour before morning dose on Days 57 and 85; 7-10 hours after morning dose on Day 57
Secondary outcome [17] 0 0
Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of SAR443122
Timepoint [17] 0 0
2-5 hours post first morning dose on Days 1, 57, and 85; 1 hour before morning dose on Days 57 and 85; 7-10 hours after morning dose on Day 57
Secondary outcome [18] 0 0
Terminal Elimination Half-Life (t1/2z) of SAR443122
Timepoint [18] 0 0
1 hour before morning dose and 2-5 hours post first morning dose on Day 85

Eligibility
Key inclusion criteria
Inclusion criteria :

* Participants with cutaneous lupus erythematosus either in the form of discoid/chronic cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus for at least 3 months before Screening.
* Participants with histologically confirmed and documented diagnosis within one year prior to Screening or during Screening period prior to randomization.
* Active cutaneous lupus erythematosus skin lesions and a Cutaneous Erythematosus.
* Disease Area and Severity Index activity (CLASI-A) =10 both at Screening and Baseline.
* Participant who was candidate for systemic treatment per Investigator's judgement.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Systemic lupus erythematosus according to the 2012 SLICC criteria with major organ involvement.
* Suspected or proven drug induced lupus erythematosus, including patients with positive antihistone autoantibody tests.
* Autoimmune disease(s) other than systemic lupus erythematosus.
* Active skin diseases that may interfere with the study or study assessments.
* Exclusion related to tuberculosis, non-tuberculous mycobacterial infections, HIV, HBV, HCV, Herpes zoster, COVID-19 and other recurrent or recent serious infections.
* Prolonged QTcF = 450 ms (by Fridericia formula) or clinically significant findings on electrocardiogram (ECG).
* Cannot avoid excessive UV exposure 4 weeks prior to baseline and during the study. Routine sun exposure through work are permitted but requires the use of sun block to sun exposed areas for at least 4 weeks prior to baseline and during the study.
* Concomitant treatment with topical immunosuppressants beyond a stable regimen of low to medium potency topical corticosteroids and/or topical calcineurin inhibitors during the study and two weeks before baseline visit.
* Initiation and/or changes in dosage of chloroquine/hydroxychloroquine within 12 weeks prior to Screening visit (or during Screening period) and/or the dose exceeding 2.3 mg/kg/day for chloroquine or 400 mg/day for hydroxychloroquine.
* Systemic treatments for cutaneous or systemic lupus erythematosus or immunosuppressive therapy for autoimmune disease other than the study medication.
* Systemic corticosteroids treatment <4 weeks before baseline visit.
* Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study.
* Laboratory abnormalities at the Screening visit.

The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/06/2023
Sample size
Target
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Camberwell
Recruitment hospital [2] 0 0
Investigational Site Number : 0360002 - East Melbourne
Recruitment postcode(s) [1] 0 0
3124 - Camberwell
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Argentina
State/province [5] 0 0
Buenos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
Santa Fe
Country [7] 0 0
Argentina
State/province [7] 0 0
Mendoza
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Chile
State/province [10] 0 0
Los Ríos
Country [11] 0 0
Chile
State/province [11] 0 0
Reg Metropolitana De Santiago
Country [12] 0 0
Czechia
State/province [12] 0 0
Brno
Country [13] 0 0
Czechia
State/province [13] 0 0
Nachod
Country [14] 0 0
Czechia
State/province [14] 0 0
Pardubice
Country [15] 0 0
Czechia
State/province [15] 0 0
Praha 6
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
Hungary
State/province [17] 0 0
Szeged
Country [18] 0 0
India
State/province [18] 0 0
Chandigarh
Country [19] 0 0
India
State/province [19] 0 0
Nagpur
Country [20] 0 0
India
State/province [20] 0 0
Nashik
Country [21] 0 0
Italy
State/province [21] 0 0
Genova
Country [22] 0 0
Italy
State/province [22] 0 0
Milano
Country [23] 0 0
Mexico
State/province [23] 0 0
Benito Juarez
Country [24] 0 0
Mexico
State/province [24] 0 0
Chihuahua
Country [25] 0 0
Mexico
State/province [25] 0 0
Monterrey, Nuevo León
Country [26] 0 0
Mexico
State/province [26] 0 0
Veracruz
Country [27] 0 0
Poland
State/province [27] 0 0
Lubelskie
Country [28] 0 0
Poland
State/province [28] 0 0
Malopolskie
Country [29] 0 0
Poland
State/province [29] 0 0
Slaskie
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Krasnodar
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Moscow
Country [32] 0 0
Russian Federation
State/province [32] 0 0
St-Petersburg
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Stavropol
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona [Barcelona]
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid, Comunidad De
Country [36] 0 0
Ukraine
State/province [36] 0 0
Ivano-Frankivsk
Country [37] 0 0
Ukraine
State/province [37] 0 0
Kyiv
Country [38] 0 0
United Kingdom
State/province [38] 0 0
London, City Of

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
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?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04781816