Cutaneous Lupus Erythematosus Clinical Trial
— CLEanOfficial 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
Verified date | June 2023 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary Objective: - Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE) Secondary Objectives: - Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity) - Assess the effect of SAR443122 on CLE induced itch and overall pain - Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo - Assess the effect of SAR443122 on the CLASI components score - Assess the effect of SAR443122 on the Investigator's global assessment for CLE (IGA-CLE) - Assess oral cavities for patients with oral lesions - Assess the disease specific quality of life (QoL) - Assess the safety and tolerability of SAR443122 in patients with CLE - Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE
Status | Completed |
Enrollment | 78 |
Est. completion date | June 26, 2023 |
Est. primary completion date | May 25, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 is candidate for systemic treatment per Investigator's judgement. 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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Country | Name | City | State |
---|---|---|---|
Argentina | Investigational Site Number :0320001 | Caba | Buenos Aires |
Argentina | Investigational Site Number :0320002 | Caba | Buenos Aires |
Argentina | Investigational Site Number :0320003 | Caba | Buenos Aires |
Argentina | Investigational Site Number :0320005 | Mendoza | |
Argentina | Investigational Site Number :0320004 | Rosario | Santa Fe |
Australia | Investigational Site Number :0360001 | Camberwell | Victoria |
Australia | Investigational Site Number :0360002 | East Melbourne | Victoria |
Canada | Investigational Site Number :1240001 | London | Ontario |
Canada | Investigational Site Number :1240002 | Sherbrooke | Quebec |
Canada | Investigational Site Number :1240005 | Toronto | Ontario |
Chile | Investigational Site Number :1520006 | Osorno | Reg Metropolitana De Santiago |
Chile | Investigational Site Number :1520001 | Santiago | Reg Metropolitana De Santiago |
Chile | Investigational Site Number :1520002 | Santiago | Reg Metropolitana De Santiago |
Chile | Investigational Site Number :1520003 | Santiago | Reg Metropolitana De Santiago |
Chile | Investigational Site Number :1520007 | Santiago | Reg Metropolitana De Santiago |
Chile | Investigational Site Number :1520009 | Valdivia | Los Ríos |
Czechia | Investigational Site Number :2030002 | Brno | |
Czechia | Investigational Site Number :2030004 | Nachod | |
Czechia | Investigational Site Number :2030006 | Pardubice | |
Czechia | Investigational Site Number :2030005 | Praha 6 | |
Hungary | Investigational Site Number :3480001 | Budapest | |
Hungary | Investigational Site Number :3480002 | Szeged | |
India | Investigational Site Number :3560002 | India | |
India | Investigational Site Number :3560003 | Nagpur | |
India | Investigational Site Number :3560004 | Nashik | |
India | Investigational Site Number :3560001 | Secunderabad | |
Italy | Investigational Site Number :3800001 | Genova | |
Italy | Investigational Site Number :3800002 | Milano | |
Mexico | Investigational Site Number :4840003 | Benito Juarez | |
Mexico | Investigational Site Number :4840004 | Chihuahua | |
Mexico | Investigational Site Number :4840001 | Monterrey | Nuevo León |
Mexico | Investigational Site Number :4840002 | Veracruz | |
Poland | Investigational Site Number :6160002 | Gdansk | Pomorskie |
Poland | Investigational Site Number :6160007 | Katowice | Slaskie |
Poland | Investigational Site Number :6160006 | Krakow | Malopolskie |
Poland | Investigational Site Number :6160004 | Lublin | Lubelskie |
Russian Federation | Investigational Site Number :6430004 | Krasnodar | |
Russian Federation | Investigational Site Number :6430002 | Moscow | |
Russian Federation | Investigational Site Number :6430005 | Moscow | |
Russian Federation | Investigational Site Number :6430001 | St-Petersburg | |
Russian Federation | Investigational Site Number :6430003 | Stavropol | |
Spain | Investigational Site Number :7240002 | Barcelona | Barcelona [Barcelona] |
Spain | Investigational Site Number :7240006 | Barcelona | |
Spain | Investigational Site Number :7240007 | Barcelona | Barcelona [Barcelona] |
Spain | Investigational Site Number :7240001 | Hospitalet de Llobregat | Catalunya [Cataluña] |
Spain | Investigational Site Number :7240004 | Madrid | Madrid, Comunidad De |
Ukraine | Investigational Site Number :8040001 | Ivano-Frankivsk | |
Ukraine | Investigational Site Number :8040002 | Kyiv | |
United Kingdom | Investigational Site Number :8260002 | London | |
United Kingdom | Investigational Site Number :8260003 | London | London, City Of |
United States | DJL Clinical Research, PLLC-Site Number:8400003 | Charlotte | North Carolina |
United States | ClinOhio Research Services-Site Number:8400007 | Columbus | Ohio |
United States | GNP Research-Site Number:8400008 | Cooper City | Florida |
United States | Prolato Clinical Research Center-Site Number:8400010 | Houston | Texas |
United States | Millennium Clinical Trials-Site Number:8400001 | Thousand Oaks | California |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States, Argentina, Australia, Canada, Chile, Czechia, Hungary, India, Italy, Mexico, Poland, Russian Federation, Spain, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent change from baseline in Cutaneous Erythematosus Disease Area and Severity Index activity (CLASI-A) sub-score | The Cutaneous Erythematosus Disease Area and Severity Index (CLASI) is a clinician rated scale composed of 56 items designed to assess the disease activity and damage in CLE in adults. The disease activity (CLASI-A) sub-score ranges from 0 to 70: 0-9 indicating mild disease, 10-20 indicating moderate disease, and 21-70 indicating severe disease. | Baseline to Week 12 | |
Secondary | Proportion of patients with physician's global assessment of disease activity (PhysGA - disease activity) of 0 or 1 (disease free or almost disease free) | The PhysGA-disease activity is a 5 point-Lickert scale instrument designed to assess physician-reported disease activity ranging from "Not active at all" to "Extremely active". | Week 12 | |
Secondary | Change from baseline in patients reported daily worst itch using Peak Pruritus Numerical Rating Scale (itch-NRS) | The itch-NRS is a single item patient-reported outcome (PRO) tool that patients will use to report the intensity of their pruritus (itch) during a daily recall period. Patients will be asked to rate their worst itch on a 0 ("No itch") to 10 ("Worst itch imaginable") NRS. | Baseline to Week 12 | |
Secondary | Change from baseline in patients reported daily worst pain using Peak Pain Numerical Rating Scale (Pain-NRS) | The Pain-NRS is a single item PRO tool that patients will use to report the intensity of their CLE-related pain (skin, oral, genital) during a daily recall period. Patients will be asked to rate their worst pain on a 0 ("No pain") to 10 ("Worst pain imaginable") NRS. | Baseline to Week 12 | |
Secondary | Proportion of CLASI-A50 and CLASI-A75 responders | The CLASI-A50/75 response is defined as a patient achieved a decrease by at least 50%/75% of CLASI-A sub-score from baseline. | Week 12 | |
Secondary | Change from baseline in CLASI components' score | Change from baseline in CLASI components' score over time | Baseline up to Week 12 | |
Secondary | Proportion of patients with the Investigator's global assessment for CLE (IGA-CLE) score of 0 or 1 (clear or almost clear) | The IGA-CLE is a clinician reported outcome that allows for clinicians to assess the overall disease activity of CLE using a 5-point scale from 0 (clear) to 4 (severe). | Week 12 | |
Secondary | Change from baseline in the Oral Health Impact Profile (OHIP-14) for patients with oral lesions at baseline | OHIP-14 is a PRO questionnaire measures people's perception of dysfunction, discomfort and disability attributed to oral conditions in adults. It is composed of 14 items that assess seven different dimensions. The OHIP-14 scores can range from 0 to 56 and higher OHIP-14 scores indicate worse oral-health-related quality of life. | Baseline to Week 12 | |
Secondary | Change from baseline in SKINDEX-29+3 total score | Skindex-29 is a PRO measure designed to assess the effects of skin disease on patients' health-related quality of life in adults. It contains 29 items, distributed across 3 domains. Individual items are scored from 0 to100 in 25-point increments with 100 representing maximal disability. The Skindex 29+3 includes a fourth subscale (3 questions) to assess lupus-specific issues. | Baseline to Week 12 | |
Secondary | Total number of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) | Screening up to end of study (Week 16) | ||
Secondary | Percent of TEAEs, SAEs and AESIs | Screening up to end of study (Week 16) | ||
Secondary | Percent of potentially clinically significant abnormalities (PCSAs) | Percent of potentially clinically significant abnormalities (PCSAs) in laboratory tests, electrocardiogram (ECG) or vital signs through end of study | Screening up to end of study (Week 16) | |
Secondary | SAR443122 plasma concentration | Day 1, Day 57 and Day 85 | ||
Secondary | Assessment of pharmacokinetic (PK) parameter: Cmax | Maximum plasma concentration | Day 1, Day 57 and Day 85 | |
Secondary | Assessment of PK parameter: tmax | Time to reach Cmax | Day 1, Day 57 and Day 85 | |
Secondary | Assessment of PK parameter: AUC0-tau | Area under the plasma concentration - time curve over the dosing interval | Day 1, Day 57 and Day 85 | |
Secondary | Assessment of PK parameter: t1/2z | Elimination half-life | Day 1, Day 57 and Day 85 |
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