Rheumatoid ArthritisPhase 1NCT05844735
A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566
A Phase 1 study testing SAR441566 and Ciprofloxacin in people with Rheumatoid Arthritis, run by Sanofi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SAR441566 and Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 23 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
TKL Research, Inc. Site Number : 8400001
Fair Lawn, New Jersey, 07410
About this study
Official title: A Two-part, Randomized Partially-blinded, Parallelgroup, Placebo- and Active Comparatorcontrolled Phase 1 Study to Evaluate the Photosafety of Repeated Oral Dose of SAR441566 in Healthy Adult Participants
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.
Read the detailed description
The overall duration of the study for each participant will be up to approximately 48 days
- Conditions
- Rheumatoid Arthritis
- Being tested
- SAR441566, Placebo, Ciprofloxacin
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR441566Drug
Tablet
PlaceboDrug
Tablet
CiprofloxacinDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Part I SAR441566 Dose A | Experimental | Participants will receive repeated low dose of SAR441566 for 7.5 days Receives: Drug: SAR441566 |
| Part I SAR441566 Dose B | Experimental | Participants will receive repeated high dose of SAR441566 for 7.5 days Receives: Drug: SAR441566 |
| Part I Placebo | Placebo comparator | Participants will receive repeated SAR441566 matching placebo tablets for 7.5 days Receives: Drug: Placebo |
| Part II Ciprofloxacin | Active comparator | Participants will receive repeated ciprofloxacin 500 mg twice-daily (BID) for 5.5 days Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On-drug Day 8
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.
Measured: On-drug Day 8
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.
Measured: On-drug Day 9
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.
Measured: On-drug Day 8
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.
Measured: On-drug Day 8
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.
Measured: On-drug Day 9
Secondary outcomes (12)
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.
Measured: Baseline (Day -2 to Day -1) and on-drug (Day 8 to Day 9)
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.
Measured: At Baseline (Day -2 to Day 1 pre-dose) and on-drug (Day 8 to Day 11)
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: Cmax
Maximum plasma concentration observed
Measured: Day 8 to Day 11
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: Tmax,
Time to reach Cmax
Measured: Day 8 to Day 11
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)
Measured: Day 8 to Day 9
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)
Measured: Up to Day 20
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.
Measured: On-drug Day 8
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.
Measured: On-drug Day 8
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.
Measured: On-drug Day 9
Treatment part II: Photosensitivity Index (PI) at 10 minutes Condition 2
Condition 2 is a UVA only [320 to 400 nm] exposure.
Measured: On-drug Day 8
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.
Measured: On-drug Day 8
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.
Measured: On-drug Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start22 May 2023
- Primary completion15 Oct 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844735
- Sponsor's protocol ID
- PDY16917
- Other IDs
- U1111-1255-5054
- Status last verified
- Sep 2025
- First submitted
- 12 Apr 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Randomized Partially-blinded, Parallelgroup, Placebo- and Active Comparatorcontrolled Phase 1 Study to Evaluate the Photosafety of Repeated Oral Dose of SAR441566 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05844735
- Acronym / sponsor ID
- PDY16917
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part I SAR441566 Dose A | Experimental | Drug: SAR441566Participants will receive repeated low dose of SAR441566 for 7.5 days |
| Part I SAR441566 Dose B | Experimental | Drug: SAR441566Participants will receive repeated high dose of SAR441566 for 7.5 days |
| Part I Placebo | Placebo comparator | Drug: PlaceboParticipants will receive repeated SAR441566 matching placebo tablets for 7.5 days |
| Part II Ciprofloxacin | Active comparator | Drug: CiprofloxacinParticipants will receive repeated ciprofloxacin 500 mg twice-daily (BID) for 5.5 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR441566Tablet | Drug | Part I SAR441566 Dose A, Part I SAR441566 Dose B |
| PlaceboTablet | Drug | Part I Placebo |
| CiprofloxacinTablet | Drug | Part II Ciprofloxacin |
Primary outcome
Treatment part I: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 1
Time frame: On-drug Day 8
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
Time frame: On-drug Day 8
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
Time frame: On-drug Day 9
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
Time frame: On-drug Day 8
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
Time frame: On-drug Day 8
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
Time frame: On-drug Day 9
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.
12 secondary outcomes
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
Time frame: Baseline (Day -2 to Day -1) and on-drug (Day 8 to Day 9)
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
Time frame: At Baseline (Day -2 to Day 1 pre-dose) and on-drug (Day 8 to Day 11)
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: Cmax
Time frame: Day 8 to Day 11
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: Tmax,
Time frame: Day 8 to Day 11
Treatment part I: Assessment of Plasma pharmacokinetic parameter of SAR441566: AUC0-tau
Time frame: Day 8 to Day 9
Treatment part I: Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)
Time frame: Up to Day 20
Treatment part II: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 1
Time frame: On-drug Day 8
Treatment part II: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 1
Time frame: On-drug Day 8
Treatment part II: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 1
Time frame: On-drug Day 9
Treatment part II: Photosensitivity Index (PI) at 10 minutes Condition 2
Time frame: On-drug Day 8
Treatment part II: Photosensitivity Index (PI) at 1 hour post UV irradiation under Condition 2
Time frame: On-drug Day 8
Treatment part II: Photosensitivity Index (PI) at 24 hours post UV irradiation under Condition 2
Time frame: On-drug Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- PDY16917 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR441566 and Ciprofloxacin in people with Rheumatoid Arthritis, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment part I: Photosensitivity Index (PI) at 10 minutes post UV irradiation under Condition 1 (time frame: On-drug Day 8). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025; AzTrials last refreshed its copy on 28 Oct 2026.