HidradenitisPhase 2NCT06118099
Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
A Phase 2 study testing Amlitelimab in people with Hidradenitis, run by Sanofi at 42 sites in 11 countries.
Trial summary
This is a parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational, placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and biological effects of treatment of subcutaneous injection of amlitelimab compared with placebo in male and female participants aged 18 to 70 years… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hidradenitis
- What is being tested?
- Amlitelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 42 sitesin 11 countries
- Study dates
- 1 Nov 2023to 10 Oct 2025
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 18 (or country's age of majority if >18) years to 70 years of age inclusive, at the time of signing the informed consent.
- Participants with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
- Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), 1 of which must be Hurley Stage II or Hurley Stage III.
- Participant must have had an inadequate response to at least a 12-week trial of an oral antibiotic for treatment of HS
Who cannot join
- Participants with a diagnosis of inflammatory conditions other than HS (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc)
- Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
Trial locations and contacts
42 sites in 11 countries.
42 sites in 11 countries
United States12 sites
Vast Skin Specialists Site Number : 8400015
Addison, Texas, 75001
Beth Israel Deaconess Medical Center Site Number : 8400006
Boston, Massachusetts, 02215
Centricity Research Site Number : 8400009
Dublin, Ohio, 43016
Center for Dermatology Clinical Research Site Number : 8400010
Fremont, California, 94538-1614
Center for Clinical Studies, LTD. LLP Site Number : 8400001
Houston, Texas, 77004
Clinical Partners, LLC Site Number : 8400003
Johnston, Rhode Island, 02919
Corazon USA, LLC (DBA Life Clinical Trials) Site Number : 8400011
Margate, Florida, 33063
Florida International Research Center Site Number : 8400016
Miami, Florida, 33173
Medical Dermatology Specialists Site Number : 8400002
Phoenix, Arizona, 85006-2754
Stryde Research Epiphany Dermatology Site Number : 8400014
Southlake, Texas, 76092
Washington University School of Medicine Site Number : 8400007
St Louis, Missouri, 63110
University of South Florida Site Number : 8400012
Tampa, Florida, 33612
France5 sites
Investigational Site Number : 2500005
La Rochelle, 17019
Investigational Site Number : 2500003
Lyon, 69003
Investigational Site Number : 2500001
Reims, 51100
Investigational Site Number : 2500004
Rouen, 76031
Investigational Site Number : 2500002
Saint-Mandé, 94163
Spain4 sites
Investigational Site Number : 7240003
Badalona, Catalunya [Cataluña], 08916
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], 08041
Investigational Site Number : 7240006
Las Palmas de Gran Canaria, Las Palmas, 35010
Investigational Site Number : 7240002
Madrid, Madrid, Comunidad de, 28046
Australia3 sites
Investigational Site Number : 0360001
Darlinghurst, New South Wales, 2010
Investigational Site Number : 0360002
Melbourne, Victoria, 3004
Investigational Site Number : 0360003
Phillip, Australian Capital Territory, 2606
Canada3 sites
Investigational Site Number : 1240007
Barrie, Ontario, L4M 7G1
Investigational Site Number : 1240002
Hamilton, Ontario, L8L 3C3
Investigational Site Number : 1240001
Québec, G1W 4R4
Chile3 sites
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, 7580206
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 7640881
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 8380465
Hungary3 sites
Investigational Site Number : 3480004
Budapest, 1083
Investigational Site Number : 3480001
Debrecen, 4032
Investigational Site Number : 3480002
Szeged, 6720
Poland3 sites
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, 02-507
Investigational Site Number : 6160004
Warsaw, 02-962
Investigational Site Number : 6160003
Wroclaw, 50-566
Germany2 sites
Investigational Site Number : 2760002
Bochum, 44791
Investigational Site Number : 2760001
Münster, 48149
Italy2 sites
Investigational Site Number : 3800001
Catania, 95123
Investigational Site Number : 3800002
Cona (Ferrara), 44124
Portugal2 sites
Investigational Site Number : 6200002
Lisbon, 1649-035
Investigational Site Number : 6200001
Lisbon, 1998-018
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Proof-of-concept Study Assessing the Efficacy and Safety of Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
This is a parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational, placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and biological effects of treatment of subcutaneous injection of amlitelimab compared with placebo in male and female participants aged 18 to 70 years with moderate to severe hidradenitis suppurativa (HS).
The purpose of this study is to measure standardized clinician reported and participant-reported outcomes (ClinRO and PRO), safety, and drug concentration. An optional long-term extension (LTE) period will assess chronic safety and efficacy over an additional 80 weeks of amlitelimab treatment.
Read more
Study details include:
- The study duration will be up to 116 weeks, including a 4-week Screening period, a 16-week double-blind treatment period (DBT), an optional 80-week LTE period and a 16-week post-treatment follow-up period.
- All participants who complete the 16-week DBT period will be offered entry into an optional LTE.
- Participants who do not wish to enter the optional LTE period or who stop treatment prior to Week 16 (Visit 6) or stop investigational medicinal product (IMP) administration prior to completing the LTE period will proceed into the 16-week post-treatment follow-up period.
- The number of planned in clinic visits will be up to six during the DBT period with an additional nine during the LTE period, plus one post-treatment follow-up end-of-study visit. Up to 11 optional in clinic visits are allowed for participants who do not wish to self-administer IMP between scheduled in clinic visits during the LTE period.
Read the detailed description
The study duration per participant will be up to 116 weeks.
- Conditions
- Hidradenitis
- Being tested
- Amlitelimab, Placebo
- Medical subject headings
- Hidradenitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlitelimabDrug
Also called SAR445229
Injection solution SC injection
PlaceboDrug
Injection solution SC injection
| Study group | Role | What they receive |
|---|---|---|
| Amlitelimab | Experimental | Subcutaneous injection (SC) as per protocol. Receives: Drug: Amlitelimab |
| Placebo | Placebo comparator | Subcutaneous injection as per protocol. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16
Hidradenitis suppurativa clinical response (HiSCR)50 is defined as ≥50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.
Measured: Week 16
Secondary outcomes (17)
Time to onset of achieving HiSCR50
HiSCR50 is defined as ≥50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.
Measured: From baseline to Week 16
Absolute change from baseline in AN count at Week 16
AN count is the total abscess and inflammatory nodule count.
Measured: Baseline to Week 16
Percentage change in AN count at Week 16
AN count is the total abscess and inflammatory nodule count.
Measured: Baseline to Week 16
Percentage of participants achieving HiSCR75 at Week 16
HiSCR75 is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.
Measured: Week 16
Percentage of participants achieving HiSCR90 at Week 16
HiSCR90 is defined as ≥90% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.
Measured: Week 16
Percentage of participants who experience improvement by at least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) stage at Week 16
The IHS4 is a validated tool to assess HS severity. A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.
Measured: Week 16
Change in absolute score from Baseline in IHS4 at Week 16
The IHS4 is a validated tool to assess HS severity. A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.
Measured: Baseline to Week 16
Percentage of participants who experience a flare at Week 16
A flare is defined as at least a 25% increase in AN count (with a minimum increase of 2 AN) relative to baseline. AN count is the total abscess and inflammatory nodule count.
Measured: Week 16
Percentage of participants achieving IHS4-55 at Week 16
IHS4-55 is defined as achievement of a 55% reduction in IHS4 score from baseline. A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.
Measured: Week 16
Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from Baseline in weekly average of daily HS-Skin Pain NRS at Week 16 among participants with baseline NRS ≥3
Hidradenitis Suppurativa-Skin pain-numeric rating scale (HS-Skin pain NRS) is scored on a 0 to 10 scale with 0 indicating "no skin pain" and 10 indicating "worst skin pain possible".
Measured: Week 16
Percentage of participants with improvement (reduction) in Peak Pruritus Numerical Rating Scale (PP-NRS) ≥4 from Baseline at Week 16 among participants with baseline PP-NRS ≥4
PP-NRS is a validated single item 0 (no itch) to10 (worst itch imaginable) numeric rating scale assessing peak pruritus (itch).
Measured: Week 16
Percentage of participants who experience 5-point reduction in DLQI at Week 16 among participants with baseline DLQI ≥4
Dermatology life quality index (DLQI) is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL). Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Measured: Week 16
Change from Baseline in the total Hidradenitis Suppurativa Quality of Life (HiSQOL) score at Week 16
HiSQOL is an instrument designed to measure the HS-specific health-related QoL of adults with HS.
Measured: Baseline to Week 16
Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interest (AESIs), and serious adverse events (SAEs) including local injection site reactions in the Safety Population
Measured: Baseline up to Week 116
Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population
Measured: Baseline up to Week 116
Serum amlitelimab concentrations measured at prespecified time points in the PK population
Measured: Day 1 up to Week 116
Incidence of antidrug antibodies (ADA) of amlitelimab at prespecified timepoints in the ADA population
Measured: Day 1 up to Week 116
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023
- Primary completion6 Feb 2025
- Study completion10 Oct 2025
Why it stopped: Sponsor decision; the decision is not related to any safety concern
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 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
- NCT06118099
- Sponsor's protocol ID
- ACT17967
- Other IDs
- U1111-1290-9497, 2023-505803-22, 2023
- Status last verified
- Jan 2026
- First submitted
- 31 Oct 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Proof-of-concept Study Assessing the Efficacy and Safety of Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT06118099
- Acronym / sponsor ID
- ACT17967
- Conditions
- Hidradenitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision; the decision is not related to any safety concern
- Enrolment
- 90 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 7 Nov 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 parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational, placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and biological effects of treatment of subcutaneous injection of amlitelimab compared with placebo in male and female participants aged 18 to 70 years with moderate to severe hidradenitis suppurativa (HS).
The purpose of this study is to measure standardized clinician reported and participant-reported outcomes (ClinRO and PRO), safety, and drug concentration. An optional long-term extension (LTE) period will assess chronic safety and efficacy over an additional 80 weeks of amlitelimab treatment.
Study details include:
- The study duration will be up to 116 weeks, including a 4-week Screening period, a 16-week double-blind treatment period (DBT), an optional 80-week LTE period and a 16-week post-treatment follow-up period.
- All participants who complete the 16-week DBT period will be offered entry into an optional LTE.
- Participants who do not wish to enter the optional LTE period or who stop treatment prior to Week 16 (Visit 6) or stop investigational medicinal product (IMP) administration prior to completing the LTE period will proceed into the 16-week post-treatment follow-up period.
- The number of planned in clinic visits will be up to six during the DBT period with an additional nine during the LTE period, plus one post-treatment follow-up end-of-study visit. Up to 11 optional in clinic visits are allowed for participants who do not wish to self-administer IMP between scheduled in clinic visits during the LTE period.
Detailed description
The study duration per participant will be up to 116 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amlitelimab | Experimental | Drug: AmlitelimabSubcutaneous injection (SC) as per protocol. |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous injection as per protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant must be 18 (or country's age of majority if >18) years to 70 years of age inclusive, at the time of signing the informed consent.
- Participants with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
- Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), 1 of which must be Hurley Stage II or Hurley Stage III.
- Participant must have had an inadequate response to at least a 12-week trial of an oral antibiotic for treatment of HS
Key exclusion criteria (3 listed)
- Participants with a diagnosis of inflammatory conditions other than HS (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc)
- Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
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 |
|---|---|---|
| AmlitelimabAlso: SAR445229Injection solution SC injection | Drug | Amlitelimab |
| PlaceboInjection solution SC injection | Drug | Placebo |
Primary outcome
The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16
Time frame: Week 16
Hidradenitis suppurativa clinical response (HiSCR)50 is defined as ≥50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.
17 secondary outcomes
Time to onset of achieving HiSCR50
Time frame: From baseline to Week 16
Absolute change from baseline in AN count at Week 16
Time frame: Baseline to Week 16
Percentage change in AN count at Week 16
Time frame: Baseline to Week 16
Percentage of participants achieving HiSCR75 at Week 16
Time frame: Week 16
Percentage of participants achieving HiSCR90 at Week 16
Time frame: Week 16
Percentage of participants who experience improvement by at least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) stage at Week 16
Time frame: Week 16
Change in absolute score from Baseline in IHS4 at Week 16
Time frame: Baseline to Week 16
Percentage of participants who experience a flare at Week 16
Time frame: Week 16
Percentage of participants achieving IHS4-55 at Week 16
Time frame: Week 16
Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from Baseline in weekly average of daily HS-Skin Pain NRS at Week 16 among participants with baseline NRS ≥3
Time frame: Week 16
Percentage of participants with improvement (reduction) in Peak Pruritus Numerical Rating Scale (PP-NRS) ≥4 from Baseline at Week 16 among participants with baseline PP-NRS ≥4
Time frame: Week 16
Percentage of participants who experience 5-point reduction in DLQI at Week 16 among participants with baseline DLQI ≥4
Time frame: Week 16
Change from Baseline in the total Hidradenitis Suppurativa Quality of Life (HiSQOL) score at Week 16
Time frame: Baseline to Week 16
Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interest (AESIs), and serious adverse events (SAEs) including local injection site reactions in the Safety Population
Time frame: Baseline up to Week 116
Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population
Time frame: Baseline up to Week 116
Serum amlitelimab concentrations measured at prespecified time points in the PK population
Time frame: Day 1 up to Week 116
Incidence of antidrug antibodies (ADA) of amlitelimab at prespecified timepoints in the ADA population
Time frame: Day 1 up to Week 116
Results and safety
The study was stopped early (reason given: Sponsor decision; the decision is not related to any safety concern). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- ACT17967 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
Related trials for Hidradenitis
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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
42 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amlitelimab in people with Hidradenitis, run by Sanofi at 42 sites in 11 countries.
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 3 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: stopped early, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, France, Spain, Australia, Canada and 6 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Sponsor decision; the decision is not related to any safety concern). Results are not available in the source record.
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?
The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16 (time frame: Week 16). 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 4 Feb 2026.