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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1280-6493 | Registry Identifier | ICTRP | |
| 2022-502370-17 | Registry Identifier | CTIS | |
| 2022-502370-17 | EudraCT Number |
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This was a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study was to evaluate the efficacy and safety of SAR442970 compared to placebo.
The study duration was up to 40 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR442970 | Experimental | Participants received SAR442970 once every two weeks (Q2W) in Period A (Day 1 to Week 16). Participants received SAR442970 Q2W in Period B (Up to Week 28). |
|
| Placebo | Placebo Comparator | Participants received placebo Q2W in Period A (Day 1 to Week 16). Participants received SAR442970 Q2W in Period B (Up to Week 28). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR442970 | Drug | 1 mL extractable volume of 150 mg/mL SAR442970 filled in 2 mL glass vial |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Period A (DB Period): Percentage of Biologic and Small Molecule Immunosuppressive-Naïve Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 | The HiSCR50 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR50 was defined as >=50% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining tunnel count. Baseline was defined as the last available value before the first dose of DB study drug. Percentages are rounded off to the tenth decimal place. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Period A (DB Period): Time to Onset of Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) | Time to onset of achieving HiSCR50 during the DB period was defined as the time from randomization to the first time of achieving HiSCR50 by Week 16. HiSCR50 was defined as >=50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count. Baseline was defined as the last available value before the first dose of DB study drug. |
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Inclusion Criteria:
Exclusion Criteria:
The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists Site Number : 8400007 | Phoenix | Arizona | 85006 | United States | ||
| Renstar Medical Research Site Number : 8400011 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39899371 | Derived | Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available. |
| Label | URL |
|---|---|
| ACT16852 Plain Language Results Summary | View source |
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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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A total of 86 participants were randomized in a 2:1 ratio to receive either SAR442970 150 milligrams (mg) or a matching placebo. The study consisted of a screening period (up to 4 weeks), a treatment period (16-week Period A [double blind {DB}] and 12-week Period B [open-label extension {OLE}]), and safety follow-up period (8 weeks).
The study started to screen participants in June 2023 and concluded enrollment in April 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Period A: Placebo | Participants received SAR442970 matched placebo every 2 weeks (Q2W) via subcutaneous (SC) injection from Day 1 to Week 16 in Period A (DB period). |
| FG001 | Period A: SAR442970 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period A (DB): Up to Week 16 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2024 | Dec 3, 2025 |
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| Placebo |
| Drug |
1 mL extractable volume of placebo filled in 2 mL glass vial |
|
| Up to Week 16 |
| Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16 | The HiSCR75 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR75 was defined as >=75% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count. Baseline was defined as the last available value before the first dose of DB study drug. | Week 16 |
| Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR90) at Week 16 | The HiSCR90 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR90 was defined as >=90% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count. Baseline was defined as the last available value before the first dose of DB study drug. | Week 16 |
| Period A (DB Period): Percentage of Participants Who Experienced Improvement by at Least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) Stage at Week 16 | The IHS4 was a validated tool to assess HS severity. The determination of IHS4 required counting inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. IHS4 score was calculated as: (number of inflammatory nodules multiplied by 1) + (number of abscesses multiplied by 2) + (number of draining tunnels multiplied by 4). A categorial IHS4 score was derived from this weighted score with total score range: mild: (<=3), moderate: (4 to 10) and severe: (>=11); higher scores indicated worse outcomes. Improvement in IHS4 by >=1 IHS4 stage was considered clinically meaningful. | Week 16 |
| Period A (DB Period): Change From Baseline at Week 16 in Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) | The IHS4 was a validated tool to assess HS severity. The determination of IHS4 required counting inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. IHS4 score was calculated as: (number of inflammatory nodules multiplied by 1) + (number of abscesses multiplied by 2) + (number of draining tunnels multiplied by 4). A categorial IHS4 score was derived from this weighted score with total score range: mild: (<=3), moderate: (4 to 10) and severe: (>=11); higher scores indicated worse outcomes. Baseline was defined as the last available value before the first dose of DB study drug. | Baseline (Day 1) and Week 16 |
| Period A (DB Period): Percentage of Participants Who Experienced a Flare Relative to Baseline at Week 16 | HS flare was defined as >=25% increase in AN count with a >=2 increase from baseline by Week 16. Baseline was defined as the last available value before the first dose of DB study drug. | Baseline (Day 1) and Week 16 |
| Period A (DB Period): Percentage of Participants Who Achieved International Hidradenitis Suppurativa Severity Score System (IHS4)-55 at Week 16 | The IHS4 was a validated tool to assess HS severity. The determination of IHS4 required counting inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. IHS4 score was calculated as: (number of inflammatory nodules multiplied by 1) + (number of abscesses multiplied by 2) + (number of draining tunnels multiplied by 4). A categorial IHS4 score was derived from this weighted score with total score range: mild: (<=3), moderate: (4 to 10) and severe: (>=11); higher scores indicated worse outcomes. IHS4-55 was defined as a 55% reduction in IHS4 score from baseline. Baseline was defined as the last available value before the first dose of DB study drug. | Week 16 |
| Period A (DB Period) + Period B (OLE Period): Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Special Interest (TEAESIs) | An AE as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were AEs that developed, worsened or became serious during the TE period. An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. | Period A was assessed from first dose of study drug (Day 1 in Period A) up to last dose of study drug + 75 days, up to 192 days; Period B was assessed from first dose in Period B to last dose of study drug + 75 days, up to 168 days |
| Period A (DB Period): Percentage of Participants Who Achieved at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in Weekly Average of Daily Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) at Week 16 | The HS-Skin Pain NRS was a unidimensional numeric rating scale (NRS) that allowed for rapid measure of skin pain that was administered multiple times with minimal administrative burden. The HS-Skin Pain NRS had a 24-hour recall period and was completed as a daily diary, ideally at the same time each day (evening) throughout the treatment period. Participants were asked to complete the HS-Skin Pain NRS for 7 consecutive days leading up to the baseline visit with a minimum of 4 completions in their daily diary. The HS-Skin Pain NRS was scored on a 0 to 10 scale; 0: no skin pain and 10: worst skin pain possible. Higher scores indicated worse outcomes. Baseline was defined as the last available value before the first dose of DB study drug. | Baseline (Day 1) and Week 16 |
| Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations | Blood samples were collected at specified timepoints for assessment of serum SAR442970 concentrations. | Baseline (Day 1), Weeks 4, 8, 10, 12 and 16 (Period A); Weeks 18, 20 and 28 (Period B) |
| Period B (OLE Period) + Period A+B (DB+OLE Period): Number of Participants With Anti-SAR442970 Antibody Response | Serum samples were collected at specified timepoints for assessment of anti-SAR442970 antibody response. Treatment-emergent anti-drug antibody (ADA) were defined as participants with at least 1 treatment-induced/boosted ADA at any time after first study drug administration up to the last available ADA sample collection. Number of participants with treatment-emergent ADA response are presented. | Period B: Placebo-SAR442970 arm were assessed from first dose of study drug in Period B up to approximately 20 weeks. Period A+B: SAR442970-SAR442970 arm were assessed from first dose of study drug in Period A up to 36 weeks |
| Ocala |
| Florida |
| 34470 |
| United States |
| ForCare Clinical Research Site Number : 8400006 | Tampa | Florida | 33613 | United States |
| Advanced Medical Research PC Site Number : 8400002 | Sandy Springs | Georgia | 30328 | United States |
| Clinical Partners, LLC Site Number : 8400010 | Johnston | Rhode Island | 02919 | United States |
| Center for Clinical Studies, LTD. LLP Site Number : 8400003 | Houston | Texas | 77004 | United States |
| Investigational Site Number : 0360002 | Liverpool | New South Wales | 2170 | Australia |
| Investigational Site Number : 0360003 | Woolloongabba | Queensland | 4102 | Australia |
| Investigational Site Number : 0560001 | Leuven | 3000 | Belgium |
| Investigational Site Number : 1240001 | Barrie | Ontario | L4M 7G1 | Canada |
| Investigational Site Number : 1240002 | London | Ontario | N6H 5L5 | Canada |
| Investigational Site Number : 1240004 | Newmarket | Ontario | L3Y 5G8 | Canada |
| Investigational Site Number : 1240007 | Québec | G1V 4T3 | Canada |
| Investigational Site Number : 1520003 | Santiago | Reg Metropolitana de Santiago | 7580206 | Chile |
| Investigational Site Number : 1520001 | Santiago | Reg Metropolitana de Santiago | 7640881 | Chile |
| Investigational Site Number : 1520002 | Santiago | Reg Metropolitana de Santiago | 8420383 | Chile |
| Investigational Site Number : 2030003 | Ostrava - Poruba | 70852 | Czechia |
| Investigational Site Number : 2030001 | Prague | 10034 | Czechia |
| Investigational Site Number : 2030002 | Praha 5 - Motol | 15006 | Czechia |
| Investigational Site Number : 2080001 | Roskilde | 4000 | Denmark |
| Investigational Site Number : 2500001 | Lyon | 69003 | France |
| Investigational Site Number : 2500002 | Nice | 06200 | France |
| Investigational Site Number : 2500003 | Reims | 51100 | France |
| Investigational Site Number : 2760005 | Berlin | 10117 | Germany |
| Investigational Site Number : 2760008 | Bochum | 44791 | Germany |
| Investigational Site Number : 2760002 | Frankfurt am Main | 60590 | Germany |
| Investigational Site Number : 2760004 | Mainz | 55131 | Germany |
| Investigational Site Number : 2760001 | Münster | 48149 | Germany |
| Investigational Site Number : 3000003 | Athens | 12462 | Greece |
| Investigational Site Number : 3000001 | Athens | 16121 | Greece |
| Investigational Site Number : 3800001 | Milan | Lombardy | 20122 | Italy |
| Investigational Site Number : 3800002 | Rozzano | Lombardy | 20089 | Italy |
| Investigational Site Number : 3800003 | Catania | 95123 | Italy |
| Investigational Site Number : 5280001 | Groningen | 9713 GZ | Netherlands |
| Investigational Site Number : 5280003 | Rotterdam | 3015 GD | Netherlands |
| Investigational Site Number : 6160001 | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| Investigational Site Number : 6160004 | Lodz | 90265 | Poland |
| Investigational Site Number : 6160003 | Wroclaw | 50-566 | Poland |
| Investigational Site Number : 6160002 | Wroclaw | 51-685 | Poland |
| Investigational Site Number : 7240003 | Barcelona | Barcelona [Barcelona] | 08041 | Spain |
| Investigational Site Number : 7240006 | Madrid | Madrid, Comunidad de | 28046 | Spain |
| Investigational Site Number : 7240001 | Madrid / Madrid | Madrid, Comunidad de | 28007 | Spain |
| Investigational Site Number : 7240004 | Manises | Valencia | 46940 | Spain |
| Investigational Site Number : 7240005 | Córdoba | 14004 | Spain |
| Investigational Site Number : 7520001 | Älvsjö | 125 44 | Sweden |
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
| FG002 | Period B: Placebo-SAR442970 | Participants who received SAR442970 matched placebo in Period A (DB period) received SAR442970 150 mg Q2W via SC injection from Week 16 to Week 28 in Period B (OLE period). |
| FG003 | Period B: SAR442970-SAR442970 | Participants who received SAR442970 in Period A (DB period) received SAR442970 150 mg Q2W via SC injection from Week 16 to Week 28 in Period B (OLE period). |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Period B (OLE): From Week 16 to Week 28 |
|
|
The randomized population included all participants from screened population who were allocated to a randomized study drug by interactive response technology regardless of whether the study drug was received or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | Period A: Placebo | Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period). |
| BG001 | Period A: SAR442970 | Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Period A (DB Period): Percentage of Biologic and Small Molecule Immunosuppressive-Naïve Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 | The HiSCR50 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR50 was defined as >=50% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining tunnel count. Baseline was defined as the last available value before the first dose of DB study drug. Percentages are rounded off to the tenth decimal place. | The biologic and small molecule immunosuppressive-naïve population included all randomized participants in the biologic and small molecule immunosuppressive-naïve subgroup who had taken at least 1 dose of study drug during Period A. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Period A (DB Period): Time to Onset of Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) | Time to onset of achieving HiSCR50 during the DB period was defined as the time from randomization to the first time of achieving HiSCR50 by Week 16. HiSCR50 was defined as >=50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count. Baseline was defined as the last available value before the first dose of DB study drug. | The biologic and small molecule immunosuppressive-naïve population included all randomized participants in the biologic and small molecule immunosuppressive-naïve subgroup who had taken at least 1 dose of study drug during Period A. | Posted | Median | 90% Confidence Interval | days | Up to Week 16 |
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| Secondary | Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16 | The HiSCR75 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR75 was defined as >=75% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count. Baseline was defined as the last available value before the first dose of DB study drug. | The biologic and small molecule immunosuppressive-naïve population included all randomized participants in the biologic and small molecule immunosuppressive-naïve subgroup who had taken at least 1 dose of study drug during Period A. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR90) at Week 16 | The HiSCR90 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR90 was defined as >=90% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count. Baseline was defined as the last available value before the first dose of DB study drug. | The biologic and small molecule immunosuppressive-naïve population included all randomized participants in the biologic and small molecule immunosuppressive-naïve subgroup who had taken at least 1 dose of study drug during Period A. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Period A (DB Period): Percentage of Participants Who Experienced Improvement by at Least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) Stage at Week 16 | The IHS4 was a validated tool to assess HS severity. The determination of IHS4 required counting inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. IHS4 score was calculated as: (number of inflammatory nodules multiplied by 1) + (number of abscesses multiplied by 2) + (number of draining tunnels multiplied by 4). A categorial IHS4 score was derived from this weighted score with total score range: mild: (<=3), moderate: (4 to 10) and severe: (>=11); higher scores indicated worse outcomes. Improvement in IHS4 by >=1 IHS4 stage was considered clinically meaningful. | The biologic and small molecule immunosuppressive-naïve population included all randomized participants in the biologic and small molecule immunosuppressive-naïve subgroup who had taken at least 1 dose of study drug during Period A. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Period A (DB Period): Change From Baseline at Week 16 in Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) | The IHS4 was a validated tool to assess HS severity. The determination of IHS4 required counting inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. IHS4 score was calculated as: (number of inflammatory nodules multiplied by 1) + (number of abscesses multiplied by 2) + (number of draining tunnels multiplied by 4). A categorial IHS4 score was derived from this weighted score with total score range: mild: (<=3), moderate: (4 to 10) and severe: (>=11); higher scores indicated worse outcomes. Baseline was defined as the last available value before the first dose of DB study drug. | The biologic and small molecule immunosuppressive-naïve population included all randomized participants in the biologic and small molecule immunosuppressive-naïve subgroup who had taken at least 1 dose of study drug during Period A. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and Week 16 |
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| Secondary | Period A (DB Period): Percentage of Participants Who Experienced a Flare Relative to Baseline at Week 16 | HS flare was defined as >=25% increase in AN count with a >=2 increase from baseline by Week 16. Baseline was defined as the last available value before the first dose of DB study drug. | The biologic and small molecule immunosuppressive-naïve population included all randomized participants in the biologic and small molecule immunosuppressive-naïve subgroup who had taken at least 1 dose of study drug during Period A. | Posted | Number | percentage of participants | Baseline (Day 1) and Week 16 |
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| Secondary | Period A (DB Period): Percentage of Participants Who Achieved International Hidradenitis Suppurativa Severity Score System (IHS4)-55 at Week 16 | The IHS4 was a validated tool to assess HS severity. The determination of IHS4 required counting inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. IHS4 score was calculated as: (number of inflammatory nodules multiplied by 1) + (number of abscesses multiplied by 2) + (number of draining tunnels multiplied by 4). A categorial IHS4 score was derived from this weighted score with total score range: mild: (<=3), moderate: (4 to 10) and severe: (>=11); higher scores indicated worse outcomes. IHS4-55 was defined as a 55% reduction in IHS4 score from baseline. Baseline was defined as the last available value before the first dose of DB study drug. | The biologic and small molecule immunosuppressive-naïve population included all randomized participants in the biologic and small molecule immunosuppressive-naïve subgroup who had taken at least 1 dose of study drug during Period A. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Period A (DB Period) + Period B (OLE Period): Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Special Interest (TEAESIs) | An AE as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were AEs that developed, worsened or became serious during the TE period. An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. | The safety population included for Period A: all randomized participants who had taken at least 1 dose of study drug during Period A, regardless of the amount of study drug administered and for Period B: all randomized participants who continued in Period B and who had taken at least 1 dose of study drug during Period B, regardless of the amount of study drug administered. | Posted | Count of Participants | Participants | Period A was assessed from first dose of study drug (Day 1 in Period A) up to last dose of study drug + 75 days, up to 192 days; Period B was assessed from first dose in Period B to last dose of study drug + 75 days, up to 168 days |
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| Secondary | Period A (DB Period): Percentage of Participants Who Achieved at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in Weekly Average of Daily Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) at Week 16 | The HS-Skin Pain NRS was a unidimensional numeric rating scale (NRS) that allowed for rapid measure of skin pain that was administered multiple times with minimal administrative burden. The HS-Skin Pain NRS had a 24-hour recall period and was completed as a daily diary, ideally at the same time each day (evening) throughout the treatment period. Participants were asked to complete the HS-Skin Pain NRS for 7 consecutive days leading up to the baseline visit with a minimum of 4 completions in their daily diary. The HS-Skin Pain NRS was scored on a 0 to 10 scale; 0: no skin pain and 10: worst skin pain possible. Higher scores indicated worse outcomes. Baseline was defined as the last available value before the first dose of DB study drug. | The biologic and small molecule immunosuppressive-naïve population included all randomized participants in the biologic and small molecule immunosuppressive-naïve subgroup who had taken at least 1 dose of study drug during Period A. Only those participants with Baseline NRS >=3 are reported. | Posted | Number | percentage of participants | Baseline (Day 1) and Week 16 |
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| Secondary | Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations | Blood samples were collected at specified timepoints for assessment of serum SAR442970 concentrations. | The pharmacokinetic (PK) population included for Period A: all participants from the safety population of Period A with at least 1 post-Baseline PK result and for Period B: all participants from the safety population of Period B with at least 1 post-Baseline PK result. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | nanogram per milliliter | Baseline (Day 1), Weeks 4, 8, 10, 12 and 16 (Period A); Weeks 18, 20 and 28 (Period B) |
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| Secondary | Period B (OLE Period) + Period A+B (DB+OLE Period): Number of Participants With Anti-SAR442970 Antibody Response | Serum samples were collected at specified timepoints for assessment of anti-SAR442970 antibody response. Treatment-emergent anti-drug antibody (ADA) were defined as participants with at least 1 treatment-induced/boosted ADA at any time after first study drug administration up to the last available ADA sample collection. Number of participants with treatment-emergent ADA response are presented. | All participants from the ADA population, i.e., treated with SAR442970 with at least 1 post-baseline ADA result are included in Part B arm and in Parts A+B arm. The combined ADA analysis provided the accurate summary of all treatment-emergent ADA response in both treatment groups after the initiation of SAR443820. | Posted | Count of Participants | Participants | Period B: Placebo-SAR442970 arm were assessed from first dose of study drug in Period B up to approximately 20 weeks. Period A+B: SAR442970-SAR442970 arm were assessed from first dose of study drug in Period A up to 36 weeks |
|
AEs and SAEs: Period A was assessed from first dose of study drug (Day 1 in Period A) up to last dose of study drug + 75 days, up to 192 days; Period B was assessed from first dose in Period B to last dose of study drug + 75 days, up to 168 days. All-cause mortality (deaths) were collected from the first dose of study drug to the end of follow-up for death for each participant, up to approximately 583 days.
Analysis was performed on the safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period A: Placebo | Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period). | 0 | 28 | 0 | 28 | 11 | 28 |
| EG001 | Period A: SAR442970 | Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period). | 0 | 58 | 0 | 58 | 32 | 58 |
| EG002 | Period B: Placebo-SAR442970 | Participants who received SAR442970 matched placebo in Period A (DB period) received SAR442970 150 mg Q2W via SC injection from Week 16 to Week 28 in Period B (OLE period). | 0 | 26 | 0 | 26 | 6 | 26 |
| EG003 | Period B: SAR442970-SAR442970 | Participants who received SAR442970 in Period A (DB period) received SAR442970 150 mg Q2W via SC injection from Week 16 to Week 28 in Period B (OLE period). | 0 | 51 | 0 | 51 | 16 | 51 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 27.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDra 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 27.1 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Pain Of Skin | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDra 27.1 | Systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDra 27.1 | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDra 27.1 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 ext 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2024 | Dec 3, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
Not provided
Not provided
| Non-compliance with study schedule |
|
| Withdrawal by Subject |
|
| Other |
|
| Non-compliance with study drug |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Pr[Diff > 0%](%) |
| 99.3 |
| Other |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
| OG001 | Period A: SAR442970 | Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period). |
| OG002 | Period B: Placebo-SAR442970 | Participants who received SAR442970 matched placebo in Period A (DB period) received SAR442970 150 mg Q2W via SC injection from Week 16 to Week 28 in Period B (OLE period). |
| OG003 | Period B: SAR442970-SAR442970 | Participants who received SAR442970 in Period A (DB period) received SAR442970 150 mg Q2W via SC injection from Week 16 to Week 28 in Period B (OLE period). |
|
|
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period). |
|
|
|
|
|
|