Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus (CLEan)
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|ClinicalTrials.gov Identifier: NCT04781816|
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : April 14, 2021
- Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE)
- 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
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Lupus Erythematosus||Drug: SAR443122 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Actual Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||January 2022|
SAR443122 for 12 weeks
Pharmaceutical form: Capsule Route of administration: Oral
Placebo Comparator: Placebo
Pharmaceutical form: Capsule Route of administration: Oral
- Percent change from baseline in Cutaneous Erythematosus Disease Area and Severity Index activity (CLASI-A) sub-score [ Time Frame: Baseline to Week 12 ]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.
- Proportion of patients with physician's global assessment of disease activity (PhysGA - disease activity) of 0 or 1 (disease free or almost disease free) [ Time Frame: Week 12 ]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".
- Change from baseline in patients reported daily worst itch using Peak Pruritus Numerical Rating Scale (itch-NRS) [ Time Frame: Baseline to Week 12 ]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.
- Change from baseline in patients reported daily worst pain using Peak Pain Numerical Rating Scale (Pain-NRS) [ Time Frame: Baseline to Week 12 ]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.
- Proportion of CLASI-A50 and CLASI-A75 responders [ Time Frame: Week 12 ]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.
- Change from baseline in CLASI components' score [ Time Frame: Baseline up to Week 12 ]Change from baseline in CLASI components' score over time
- Proportion of patients with the Investigator's global assessment for CLE (IGA-CLE) score of 0 or 1 (clear or almost clear) [ Time Frame: Week 12 ]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).
- Change from baseline in Modified Oral Mucositis Index (MOMI) for patients with oral lesions at baseline [ Time Frame: Baseline to Week 12 ]MOMI is a semi quantitative scale designed to assess oral lesions based upon the severity of the lesions and the number of sites involved, including the intensity score for erythema, ranging from 0 to 3 and the score for ulcerations based on area of ulceration.
- Change from baseline in the Oral Health Impact Profile (OHIP-14) for patients with oral lesions at baseline [ Time Frame: Baseline to Week 12 ]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.
- Change from baseline in SKINDEX-29+3 total score [ Time Frame: Baseline to Week 12 ]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.
- Total number of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) [ Time Frame: Screening up to end of study (Week 16) ]
- Percent of TEAEs, SAEs and AESIs [ Time Frame: Screening up to end of study (Week 16) ]
- Percent of potentially clinically significant abnormalities (PCSAs) [ Time Frame: Screening up to end of study (Week 16) ]Percent of potentially clinically significant abnormalities (PCSAs) in laboratory tests, electrocardiogram (ECG) or vital signs through end of study
- SAR443122 plasma concentration [ Time Frame: Day 1, Day 57 and Day 85 ]
- Assessment of pharmacokinetic (PK) parameter: Cmax [ Time Frame: Day 1, Day 57 and Day 85 ]Maximum plasma concentration
- Assessment of PK parameter: tmax [ Time Frame: Day 1, Day 57 and Day 85 ]Time to reach Cmax
- Assessment of PK parameter: AUC0-tau [ Time Frame: Day 1, Day 57 and Day 85 ]Area under the plasma concentration - time curve over the dosing interval
- Assessment of PK parameter: t1/2z [ Time Frame: Day 1, Day 57 and Day 85 ]Elimination half-life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04781816
|Contact: Trial Transparency email recommended (Toll free number for US & Canada)||800-633-1610 ext option 6||Contact-US@sanofi.com|
|Investigational Site Number 0360001||Recruiting|
|Camberwell, Australia, 3124|
|Investigational Site Number 0360002||Recruiting|
|East Melbourne, Australia, 3002|
|Investigational Site Number 1240002||Recruiting|
|Sherbrooke, Canada, J1L 0H8|
|Study Director:||Clinical Sciences & Operations||Sanofi|