Phase 2
N=78
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT04781816 ↗Enrolled (actual)
78
Serious AEs
1.3%
Results posted
Jun 2024
Primary outcome: Primary: Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12 — -37.05; -42.76 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SAR443122 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12 |
-37.05; -42.76 | — |
| SECONDARY 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 |
32.5; 44.74 | — |
| SECONDARY Change From Baseline in Participants Reported Daily Worst Itch Using Peak Pruritus Numerical Rating Scale (Itch-NRS) at Week 12 |
-0.62; -2.16 | — |
| SECONDARY Change From Baseline in Participants Reported Daily Worst Pain Using Peak Pain Numerical Rating Scale (Pain-NRS) at Week 12 |
-0.93; -1.72 | — |
| SECONDARY Percentage of CLASI-A50 and CLASI-A75 Responders at Week 12 |
45; 44.74; 10; 23.68 | — |
| SECONDARY Change From Baseline in CLASI Components' Score Over Time |
-2.33; -2.14; -3.37; -3.42; -4.97; -4.17 | — |
| SECONDARY 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 |
15.79; 26.47 | — |
| SECONDARY Change From Baseline to Week 12 in the Oral Health Impact Profile 14-Item Version (OHIP-14) for Participants With Oral Lesions at Baseline |
-2.90; -0.15 | — |
| SECONDARY Change From Baseline in SKINDEX-29+3 Total Score at Week 12 |
-9.09; -11.09 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESIs) |
18; 22; 1; 0; 1; 2 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With PCSA in Clinical Chemistry |
4; 1; 1; 3; 0; 0 | — |
| SECONDARY Number of Participants With PCSA in Urinalysis |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With PCSA in Electrocardiogram (ECG) |
2; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With PCSA in Vital Signs |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of SAR443122 |
3334; 4875; 4896 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of SAR443122 |
2.80; 2.60; 2.55 | — |
| SECONDARY Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of SAR443122 |
30151; 40194; 44489 | — |
| SECONDARY Terminal Elimination Half-Life (t1/2z) of SAR443122 |
7.62 | — |
Summary
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
Eligibility 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.
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.
Data sourced from ClinicalTrials.gov (NCT04781816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.