HidradenitisPhase 1NCT07629336
SAR447971 First-in-human Study
A Phase 1 study testing SAR447971 in people with Hidradenitis and Healthy Volunteers, run by Sanofi at 1 site in Netherlands.
Trial summary
SAD20411 is a single-center, first-in-human, double-blind, randomized, placebo-controlled, sequential single ascending dose study in healthy male and/or female participants with a pilot food effect investigation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis, Healthy Volunteers
- What is being tested?
- SAR447971
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 May 2026to 17 Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For participation in SAD20411/MAD20412:
- Male and/or female participant, between 18 and 55 years of age, inclusive at the time of signing the ICF.
- Appearing healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- For participation in MAD24339:
- Age ≥18 and ≤65 years of age at the time of signing informed consent.
- A diagnosis of HS made by a dermatologist at least 6 months prior to baseline visit.
- HS lesions present in at least 2 distinct anatomic areas (e. g., left and right axilla; or left axilla and left inguino-crural fold), one of which must be Hurley Stage II or Hurley Stage III.
- Total AN count of ≥4 at the baseline visit. - Draining tunnel count of ≤20 at the baseline visit.
Who cannot join
- For participation in SAD20411/MAD20412:
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female) or signs of acute illness. Active or chronic infection requiring systemic treatment within 4 weeks prior to baseline. Known history of immunosuppression or suspected current immunosuppression.
- For participation in MAD24339:
- Any active skin disease or condition other than HS (including but not limited to inflammatory skin diseases and cutaneous infections) that may interfere with assessment of HS.
- Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline.
- Use of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.
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- Treatment with systemic antibiotics for HS within 14 days prior to the baseline visit.
- Non-biologic systemic therapies with potential therapeutic impact on HS <28 days or five half-lives prior to baseline visit.
- Any history of prior treatment with any systemic biologic with a potential therapeutic impact on HS.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
Netherlands1 site, 1 recruiting
- Recruiting
Investigational Site Number: 5280001
Leiden, 2333
About this study
Official title: A Randomized, First-in-human, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses (SAD20411) and Multiple Ascending Doses (MAD20412) of SAR447971 With Food Effect Evaluation in Healthy Participants and of Multiple Ascending Doses (MAD24339) of SAR447971 in Patients With Hidradenitis Suppurativa
SAD20411 is a single-center, first-in-human, double-blind, randomized, placebo-controlled, sequential single ascending dose study in healthy male and/or female participants with a pilot food effect investigation.
MAD20412 is a single-center, double-blind, randomized, placebo-controlled, sequential multiple ascending dose study in healthy male and/or female participants.
Read more
MAD24339 is an open-label, sequential multiple ascending dose study in hidradenitis suppurativa (HS) male and/or female participants.
Number of participants The total expected number of healthy participants is approximately 102 and the total number of HS participants is expected to be approximately 20.
- SAD20411 will enroll up to 54 participants
- MAD20412 will enroll up to 48 participants
- MAD24339 will enroll up to 20 participants
Duration of study The anticipated study duration per participant is up to approximately 10 weeks in SAD20411 and MAD20412, and up to approximately 12 weeks in MAD24339.
- Conditions
- Hidradenitis, Healthy Volunteers
- Being tested
- SAR447971, Placebo
- Medical subject headings
- Hidradenitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR447971Drug
Also called KT-485
Pharmaceutical form: Tablet Route of administration: Oral
PlaceboDrug
Pharmaceutical form: Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| SAR447971 | Experimental | Single or multiple doses by mouth as per protocol Receives: Drug: SAR447971 |
| Placebo | Placebo comparator | Single or multiple doses by mouth as per protocol Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD20411: Incidence of treatment emergent adverse events (TEAEs)
Measured: Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
Measured: Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in vital signs
Measured: Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Measured: Day 1 to Day 15
MAD20412: Incidence of treatment emergent adverse events (TEAEs)
Measured: Day 1 to Day 29
MAD20412: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
Measured: Day 1 to Day 29
MAD20412: Incidence of clinically significant abnormalities in vital signs
Measured: Day 1 to Day 29
MAD20412: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Measured: Day 1 to Day 29
MAD24339: Incidence of treatment emergent adverse events (TEAEs)
Measured: Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
Measured: Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in vital signs
Measured: Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Measured: Day 1 to Day 42
Secondary outcomes (11)
SAD20411: PK parameter - Cmax
Maximum serum concentration observed.
Measured: Day 1 to Day 15
SAD20411: PK parameter - tmax
Time to reach Cmax.
Measured: Day 1 to Day 15
SAD20411:PK parameter - AUC
Area under the plasma concentration versus time curve extrapolated to infinity.
Measured: Day 1 to Day 15
SAD20411: PK parameter - Cmax in fed and fasted state
Maximum serum concentration observed.
Measured: Day 1 to Day 15
SAD20411: PK parameter - tmax in fed and fasted state
Time to reach Cmax.
Measured: Day 1 to Day 15
SAD20411: PK parameter - AUC in fed and fasted state
Area under the plasma concentration versus time curve extrapolated to infinity.
Measured: Day 1 to Day 15
MAD20412: PK parameter - Cmax
Maximum serum concentration observed.
Measured: Day 1 to Day 22
MAD20412: PK parameter - tmax
Time to reach Cmax.
Measured: Day 1 to Day 22
MAD20412: PK parameter - AUC0-tau
Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval
Measured: Day 1 to Day 22
MAD24339: IRAK4 expression in skin biopsies before and after repeated doses of SAR447971
Measured: Day 1 to Day 42
MAD24339: Plasma SAR447971 concentrations at pre-specified visits and time points
Measured: Day 1 to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start26 May 2026
- Primary completion17 Apr 2028 (estimated)
- Study completion17 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HidradenitisStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kymera Therapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629336
- Sponsor's protocol ID
- SAD20411-MAD20412-MAD24339
- Other IDs
- 2026-525333-22-00, U1111-1334-4747
- Status last verified
- Oct 2026
- First submitted
- 22 May 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, First-in-human, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses (SAD20411) and Multiple Ascending Doses (MAD20412) of SAR447971 With Food Effect Evaluation in Healthy Participants and of Multiple Ascending Doses (MAD24339) of SAR447971 in Patients With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT07629336
- Acronym / sponsor ID
- SAD20411-MAD20412-MAD24339
- Conditions
- Hidradenitis, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Kymera Therapeutics, Inc.
- Study start
- 26 May 2026 (actual)
- Primary completion
- 17 Apr 2028 (estimated)
- Study completion
- 17 Apr 2028 (estimated)
- First posted
- 5 Jun 2026 (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.
SAD20411 is a single-center, first-in-human, double-blind, randomized, placebo-controlled, sequential single ascending dose study in healthy male and/or female participants with a pilot food effect investigation.
MAD20412 is a single-center, double-blind, randomized, placebo-controlled, sequential multiple ascending dose study in healthy male and/or female participants.
MAD24339 is an open-label, sequential multiple ascending dose study in hidradenitis suppurativa (HS) male and/or female participants.
Number of participants The total expected number of healthy participants is approximately 102 and the total number of HS participants is expected to be approximately 20.
- SAD20411 will enroll up to 54 participants
- MAD20412 will enroll up to 48 participants
- MAD24339 will enroll up to 20 participants
Duration of study The anticipated study duration per participant is up to approximately 10 weeks in SAD20411 and MAD20412, and up to approximately 12 weeks in MAD24339.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR447971 | Experimental | Drug: SAR447971Single or multiple doses by mouth as per protocol |
| Placebo | Placebo comparator | Drug: PlaceboSingle or multiple doses by mouth as per protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and/or female participant, between 18 and 55 years of age, inclusive at the time of signing the ICF.
- Appearing healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Age ≥18 and ≤65 years of age at the time of signing informed consent.
- A diagnosis of HS made by a dermatologist at least 6 months prior to baseline visit.
- HS lesions present in at least 2 distinct anatomic areas (e. g., left and right axilla; or left axilla and left inguino-crural fold), one of which must be Hurley Stage II or Hurley Stage III.
Key exclusion criteria (10 listed)
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female) or signs of acute illness. Active or chronic infection requiring systemic treatment within 4 weeks prior to baseline. Known history of immunosuppression or suspected current immunosuppression.
- Any active skin disease or condition other than HS (including but not limited to inflammatory skin diseases and cutaneous infections) that may interfere with assessment of HS.
- Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline.
- Use of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.
- Treatment with systemic antibiotics for HS within 14 days prior to the baseline visit.
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 |
|---|---|---|
| SAR447971Also: KT-485Pharmaceutical form: Tablet Route of administration: Oral | Drug | SAR447971 |
| PlaceboPharmaceutical form: Tablet Route of administration: Oral | Drug | Placebo |
Primary outcome
SAD20411: Incidence of treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
Time frame: Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in vital signs
Time frame: Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Time frame: Day 1 to Day 15
MAD20412: Incidence of treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Day 29
MAD20412: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
Time frame: Day 1 to Day 29
MAD20412: Incidence of clinically significant abnormalities in vital signs
Time frame: Day 1 to Day 29
MAD20412: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Time frame: Day 1 to Day 29
MAD24339: Incidence of treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
Time frame: Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in vital signs
Time frame: Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Time frame: Day 1 to Day 42
11 secondary outcomes
SAD20411: PK parameter - Cmax
Time frame: Day 1 to Day 15
SAD20411: PK parameter - tmax
Time frame: Day 1 to Day 15
SAD20411:PK parameter - AUC
Time frame: Day 1 to Day 15
SAD20411: PK parameter - Cmax in fed and fasted state
Time frame: Day 1 to Day 15
SAD20411: PK parameter - tmax in fed and fasted state
Time frame: Day 1 to Day 15
SAD20411: PK parameter - AUC in fed and fasted state
Time frame: Day 1 to Day 15
MAD20412: PK parameter - Cmax
Time frame: Day 1 to Day 22
MAD20412: PK parameter - tmax
Time frame: Day 1 to Day 22
MAD20412: PK parameter - AUC0-tau
Time frame: Day 1 to Day 22
MAD24339: IRAK4 expression in skin biopsies before and after repeated doses of SAR447971
Time frame: Day 1 to Day 42
MAD24339: Plasma SAR447971 concentrations at pre-specified visits and time points
Time frame: Day 1 to Day 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- SAD20411-MAD20412-MAD24339 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.
Trial Transparency email recommended (Toll free for US & Canada) contact
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 SAR447971 in people with Hidradenitis and Healthy Volunteers, run by Sanofi at 1 site in Netherlands.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAD20411: Incidence of treatment emergent adverse events (TEAEs) (time frame: Day 1 to Day 15). The study lists 12 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 27 Oct 2026.