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Monoclonal Antibodies

Part I SAR441566 Dose A for Rheumatoid Arthritis

Phase 1
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (day -2 to day 1 pre-dose) and on-drug (day 8 to day 11)
Awards & highlights

Study Summary

This trial will test how the drug SAR441566 affects sensitivity to UV light in healthy adults.

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline (day -2 to day 1 pre-dose) and on-drug (day 8 to day 11)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (day -2 to day 1 pre-dose) and on-drug (day 8 to day 11) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment part I: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 1
Treatment part I: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 2
Treatment part I: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 1
+3 more
Secondary outcome measures
Treatment part I & part II: Evaluation of local skin reactions following exposure to UV irradiation at 10 minutes, 1 hour, 24 hours, 48 hours, and 72 hours postirradiation under Condition 1, Condition 2, and Condition 3
Treatment part I & part II: Minimum Erythema Dose (MED) percent change from baseline at 10 minutes, 1 hour, and 24 hours postirradiation measured under Condition 1 and Condition 2
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: AUC0-tau
+9 more

Side effects data

From 2012 Phase 4 trial • 35 Patients • NCT01749605
6%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nitrofurantoin 100 mg
Ciprofloxacin 250 mg

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Part I SAR441566 Dose BExperimental Treatment1 Intervention
Participants will receive repeated high dose of SAR441566 for 7.5 days
Group II: Part I SAR441566 Dose AExperimental Treatment1 Intervention
Participants will receive repeated low dose of SAR441566 for 7.5 days
Group III: Part II CiprofloxacinActive Control1 Intervention
Participants will receive repeated ciprofloxacin 500 mg twice-daily (BID) for 5.5 days
Group IV: Part I PlaceboPlacebo Group1 Intervention
Participants will receive repeated SAR441566 matching placebo tablets for 7.5 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR441566
2023
Completed Phase 1
~110

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,920 Total Patients Enrolled
25 Trials studying Rheumatoid Arthritis
7,184 Patients Enrolled for Rheumatoid Arthritis
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,778 Total Patients Enrolled
16 Trials studying Rheumatoid Arthritis
3,068 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

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

Is the eligibility range for this research trial encompassing individuals aged over twenty?

"Individuals aged between 18 and 55 are eligible for this research study."

Answered by AI

Is there an open call for participants in this experiment?

"Data on clinicaltrials.gov reveals that the trial is actively recruiting participants, as it was initially posted on May 22nd 2023 and last revised on May 26th of the same year."

Answered by AI

How many participants can enroll in this research endeavor?

"Affirmative. As indicated on clinicaltrials.gov, this clinical trial is actively recruiting individuals for their research. The experiment was first introduced on May 22nd 2023 and modified most recently on May 26th 2023. Currently, they are looking to recruit 60 patients from 1 site in particular."

Answered by AI

Is there a possibility of my participation in this research endeavor?

"This clinical trial requires its participants to have been diagnosed with rheumatoid arthritis and lie between 18 and 55 years old. Approximately 60 people are being enrolled at this time."

Answered by AI

Has the Food and Drug Administration authorized Part I SAR441566 Dose A to be used?

"In consideration of the limited clinical data, Power appraised Part I SAR441566 Dose A's safety with a score of 1. This is due to it being in Phase 1 trial and thus having restricted information regarding efficacy and security."

Answered by AI

What primary outcomes is this medical study aiming to determine?

"The primary endpoint of this clinical trial, assessed over On-drug Day 8 time frame, is the Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 2. Secondary endpoints include AUC0-tau – an Area Under Curve calculation for SAR441566's plasma concentration spanning 0 to 24 hours - and two additional PI measurements: one taken after a UVA only [320 to 400 nm] exposure at 10 minutes as well as another taken 24 hours following such light therapy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566
2023. "A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05844735.
~31 spots leftby May 2025
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