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SAR443122 for Cutaneous Lupus Erythematosus(CLEan Trial)

Investigational Site Number :1520006, Osorno, Chile
SAR443122 +1 morePhase 2Waitlist AvailableResearch Sponsored by Sanofi

CLEan Trial Summary

This trial is testing a new drug for lupus to see if it is effective and safe.

Eligible Conditions
  • Cutaneous Lupus Erythematosus

CLEan Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have a type of skin condition called cutaneous lupus erythematosus for at least 3 months before the screening.
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Your diagnosis of the medical condition being studied was confirmed with tissue or cell testing within the past year or during the screening period.
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You have active skin lesions caused by a condition called cutaneous lupus erythematosus or Cutaneous Erythematosus.
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You experience a high level of activity in your skin disease, measured by a specific scale called CLASI-A.
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The doctor thinks you need treatment that involves medication that affects your entire body.

CLEan Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 57 and day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 57 and day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lupus Erythematosus, Cutaneous
Secondary outcome measures
Assessment of PK parameter: AUC0-tau
Assessment of PK parameter: t1/2z
Assessment of PK parameter: tmax
+13 more

CLEan Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR443122Experimental Treatment1 Intervention
SAR443122 for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR443122
2020
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,132 Previous Clinical Trials
3,108,115 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
848 Previous Clinical Trials
1,655,002 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many hospitals or research centers is this experiment taking place?

"GNP Research-Site Number:8400008 in Cooper City, Florida, Millennium Clinical Trials-Site Number:8400001 in Thousand Oaks, California, DJL Clinical Research, PLLC-Site Number:8400003 in Charlotte, North Carolina, Californty, Florida, Millennium Clinical Trials-Site Number:8400001 in Thousand Oaks, California, DJL Clinical Research, PLLC-Site Number:8400003 in Charlotte, North Carolina are some of the locations where this trial is taking place. There are also 13 other sites across the country."

Answered by AI

How can I qualify to participate in this clinical trial?

"The medical trial, which was originally advertised on April 1st 2021, is still searching for patients according to the listing on clinicaltrials.gov."

Answered by AI

Are patients who are over 25 years old welcomed in this clinical trial?

"The age range for potential participants in this trial is 18 to 80 years old."

Answered by AI

Are there certain restrictions for who is eligible to participate in this clinical trial?

"Libman-Sacks disease is the primary inclusion criteria for this trial. Between 18 to 80 years old, around 88 participants are needed for the study."

Answered by AI

Could you explain SAR443122's impact on patients' safety?

"While there is data backing SAR443122's safety, as this is only a Phase 2 trial, there isn't enough evidence yet to suggest that it is an effective medication."

Answered by AI

How many patients are included in this clinical trial at maximum capacity?

"In order for this study to commence, 88 patients must meet the listed inclusion criteria. The trial will be conducted by sponsor Sanofi at different locations, two of which are GNP Research-Site Number:8400008 in Cooper City, Florida and Millennium Clinical Trials-Site Number:8400001 in Thousand Oaks, California, Florida and Millennium Clinical Trials-Site Number:8400001 in Thousand Oaks, California."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
2021. "Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04781816.
~22 spots leftby Nov 2024
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