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A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAR441566
Placebo
Ciprofloxacin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male or female participants who are between 18 and 55 years of age, (inclusive), at the time of signing the informed consent Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG. Participants with Fitzpatrick skin type classification of I, II, or III (I always burns easily, never tans, II always burns easily, tans minimally, III Burns moderately, tans gradually) Body weight within 50.0 and 100.0 kg (inclusive), and body mass index (BMI) within the range 18.0 and 32.0 kg/m2 (inclusive) Exclusion Criteria: A positive hepatitis B (HBsAg, anti-HBc), hepatitis C or HIV test at screening, indicative of a current or past infection A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon TB Gold or T-SPOT) History of invasive opportunistic infections Participants with a history of Clostridium difficile-associated diarrhea Participants with a history of malignancy occurring within 5 years before inclusion (except adequately treated carcinoma in situ of the cervix, or adequately treated non-metastatic squamous cell or basal cell carcinoma of the skin) Active skin disorders or alterations such as tattoos on the back where photosensitivity testing will be performed or unprotected ultraviolet exposure of the test areas within 4 weeks prior to baseline photo testing that the Investigator considers will interfere with study assessments Abnormal skin response during preliminary or baseline phototoxicity evaluations Any medication within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication (whichever is longer); any acetaminophen intake within 2 days prior the inclusion and any biologics (antibody or its derivatives) given within 4 months before screening Any participant enrolled or having participated, in this or any other clinical study involving an IMP or in any other type of medical research within the past 14 days (last day of IMP dosing in the previous clinical trial) or 5 half-lives whichever is longer, before screening Clinical signs and symptoms consistent with COVID-19 or laboratory-confirmed SARS-CoV-2 infection; SARS-CoV-2 infection within 4 weeks prior to screening; and/or history of severe course of COVID-19 If female, pregnancy (defined as positive beta-HCG blood test and/or positive urine pregnancy test), breast-feeding The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Sites / Locations

  • TKL Research, Inc.-Site Number:8400001Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Part I SAR441566 Dose A

Part I SAR441566 Dose B

Part I Placebo

Part II Ciprofloxacin

Arm Description

Participants will receive repeated low dose of SAR441566 for 7.5 days

Participants will receive repeated high dose of SAR441566 for 7.5 days

Participants will receive repeated SAR441566 matching placebo tablets for 7.5 days

Participants will receive repeated ciprofloxacin 500 mg twice-daily (BID) for 5.5 days

Outcomes

Primary Outcome Measures

Treatment part I: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 1
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation. Condition 1 is Full range solar ultraviolet B/ultraviolet A (UVB/UVA) [290 to 400 nm] exposure.
Treatment part I: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 1
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation. Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.
Treatment part I: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 1
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation. Condition 1 is a Full range solar UVB/UVA [290 to 400 nm] exposure.
Treatment part I: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 2
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation. Condition 2 is a UVA only [320 to 400 nm] exposure.
Treatment part I: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 2
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation. Condition 2 is a UVA only [320 to 400 nm] exposure.
Treatment part I: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 2
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation. Condition 2 is a UVA only [320 to 400 nm] exposure.

Secondary Outcome Measures

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
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure and condition 2 is a UVA only [320 to 400 nm] exposure.
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
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure, condition 2 is a UVA only [320 to 400 nm] exposure and condition 3 is a full solar range UVB/UVA + UVA [16 J/cm2] exposure.
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: Cmax
Maximum plasma concentration observed
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: Tmax,
Time to reach Cmax
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: AUC0-tau
Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (0 to 24 hours)
Treatment part I: Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)
Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including serious adverse event (SAE) and adverse event of special interests (AESI)
Treatment part II: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 1
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.
Treatment part II: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 1
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.
Treatment part II: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 1
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.
Treatment part II: Photosensitivity Index (PI) at 10 minutes Condition 2
Condition 2 is a UVA only [320 to 400 nm] exposure.
Treatment part II: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 2
Condition 2 is a UVA only [320 to 400 nm] exposure.
Treatment part II: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 2
Condition 2 is a UVA only [320 to 400 nm] exposure.

Full Information

First Posted
April 12, 2023
Last Updated
August 1, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT05844735
Brief Title
A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566
Official Title
A Two-part, Randomized Partially-blinded, Parallel-group, Placebo- and Active Comparator-controlled Phase 1 Study to Evaluate the Photosafety of Repeated Oral Dose of SAR441566 in Healthy Adult Participants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
September 17, 2023 (Anticipated)
Study Completion Date
September 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single center randomized parallel-group partially-blinded, 4-arm Phase 1 study to evaluate the phototoxic potential of two dose levels of SAR441566 treatment compared to placebo and the active comparator, ciprofloxacin, in healthy adults, 18 to 55 years of age. There will be two parts: Part I is a randomized placebo-controlled trial comparing sensitivity to ultraviolet (UV) light in participants treated with SAR441566 to those treated with placebo. Part II is an open label arm consisting of participants treated with ciprofloxacin which induces mild phototoxicity and serves as a positive control.
Detailed Description
The overall duration of the study for each participant will be up to approximately 48 days

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Applicable for Part I
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part I SAR441566 Dose A
Arm Type
Experimental
Arm Description
Participants will receive repeated low dose of SAR441566 for 7.5 days
Arm Title
Part I SAR441566 Dose B
Arm Type
Experimental
Arm Description
Participants will receive repeated high dose of SAR441566 for 7.5 days
Arm Title
Part I Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive repeated SAR441566 matching placebo tablets for 7.5 days
Arm Title
Part II Ciprofloxacin
Arm Type
Active Comparator
Arm Description
Participants will receive repeated ciprofloxacin 500 mg twice-daily (BID) for 5.5 days
Intervention Type
Drug
Intervention Name(s)
SAR441566
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Treatment part I: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 1
Description
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation. Condition 1 is Full range solar ultraviolet B/ultraviolet A (UVB/UVA) [290 to 400 nm] exposure.
Time Frame
On-drug Day 8
Title
Treatment part I: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 1
Description
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation. Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.
Time Frame
On-drug Day 8
Title
Treatment part I: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 1
Description
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation. Condition 1 is a Full range solar UVB/UVA [290 to 400 nm] exposure.
Time Frame
On-drug Day 9
Title
Treatment part I: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 2
Description
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation. Condition 2 is a UVA only [320 to 400 nm] exposure.
Time Frame
On-drug Day 8
Title
Treatment part I: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 2
Description
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation. Condition 2 is a UVA only [320 to 400 nm] exposure.
Time Frame
On-drug Day 8
Title
Treatment part I: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 2
Description
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation. Condition 2 is a UVA only [320 to 400 nm] exposure.
Time Frame
On-drug Day 9
Secondary Outcome Measure Information:
Title
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
Description
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure and condition 2 is a UVA only [320 to 400 nm] exposure.
Time Frame
Baseline (Day -2 to Day -1) and on-drug (Day 8 to Day 9)
Title
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
Description
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure, condition 2 is a UVA only [320 to 400 nm] exposure and condition 3 is a full solar range UVB/UVA + UVA [16 J/cm2] exposure.
Time Frame
At Baseline (Day -2 to Day 1 pre-dose) and on-drug (Day 8 to Day 11)
Title
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: Cmax
Description
Maximum plasma concentration observed
Time Frame
Day 8 to Day 11
Title
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: Tmax,
Description
Time to reach Cmax
Time Frame
Day 8 to Day 11
Title
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: AUC0-tau
Description
Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (0 to 24 hours)
Time Frame
Day 8 to Day 9
Title
Treatment part I: Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)
Description
Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including serious adverse event (SAE) and adverse event of special interests (AESI)
Time Frame
Up to Day 20
Title
Treatment part II: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 1
Description
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.
Time Frame
On-drug Day 8
Title
Treatment part II: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 1
Description
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.
Time Frame
On-drug Day 8
Title
Treatment part II: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 1
Description
Condition 1 is full range solar UVB/UVA [290 to 400 nm] exposure.
Time Frame
On-drug Day 9
Title
Treatment part II: Photosensitivity Index (PI) at 10 minutes Condition 2
Description
Condition 2 is a UVA only [320 to 400 nm] exposure.
Time Frame
On-drug Day 8
Title
Treatment part II: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 2
Description
Condition 2 is a UVA only [320 to 400 nm] exposure.
Time Frame
On-drug Day 8
Title
Treatment part II: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 2
Description
Condition 2 is a UVA only [320 to 400 nm] exposure.
Time Frame
On-drug Day 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female participants who are between 18 and 55 years of age, (inclusive), at the time of signing the informed consent Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG. Participants with Fitzpatrick skin type classification of I, II, or III (I always burns easily, never tans, II always burns easily, tans minimally, III Burns moderately, tans gradually) Body weight within 50.0 and 100.0 kg (inclusive), and body mass index (BMI) within the range 18.0 and 32.0 kg/m2 (inclusive) Exclusion Criteria: A positive hepatitis B (HBsAg, anti-HBc), hepatitis C or HIV test at screening, indicative of a current or past infection A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon TB Gold or T-SPOT) History of invasive opportunistic infections Participants with a history of Clostridium difficile-associated diarrhea Participants with a history of malignancy occurring within 5 years before inclusion (except adequately treated carcinoma in situ of the cervix, or adequately treated non-metastatic squamous cell or basal cell carcinoma of the skin) Active skin disorders or alterations such as tattoos on the back where photosensitivity testing will be performed or unprotected ultraviolet exposure of the test areas within 4 weeks prior to baseline photo testing that the Investigator considers will interfere with study assessments Abnormal skin response during preliminary or baseline phototoxicity evaluations Any medication within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication (whichever is longer); any acetaminophen intake within 2 days prior the inclusion and any biologics (antibody or its derivatives) given within 4 months before screening Any participant enrolled or having participated, in this or any other clinical study involving an IMP or in any other type of medical research within the past 14 days (last day of IMP dosing in the previous clinical trial) or 5 half-lives whichever is longer, before screening Clinical signs and symptoms consistent with COVID-19 or laboratory-confirmed SARS-CoV-2 infection; SARS-CoV-2 infection within 4 weeks prior to screening; and/or history of severe course of COVID-19 If female, pregnancy (defined as positive beta-HCG blood test and/or positive urine pregnancy test), breast-feeding The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial transparency email recommended (Toll free for US & Canada
Phone
800-633-1610
Ext
option 6
Email
contact-us@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
TKL Research, Inc.-Site Number:8400001
City
Fair Lawn
State/Province
New Jersey
ZIP/Postal Code
07410
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566

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