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Trial Outcomes & Findings for A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa (NCT NCT05849922)

NCT ID: NCT05849922

Last Updated: 2026-01-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

Week 16

Results posted on

2026-01-29

Participant Flow

The study started to screen participants in June 2023 and concluded enrollment in April 2024.

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).

Participant milestones

Participant milestones
Measure
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).
Period A: SAR442970
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
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).
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).
Period A (DB): Up to Week 16
STARTED
28
58
0
0
Period A (DB): Up to Week 16
COMPLETED
26
52
0
0
Period A (DB): Up to Week 16
NOT COMPLETED
2
6
0
0
Period B (OLE): From Week 16 to Week 28
STARTED
0
0
26
51
Period B (OLE): From Week 16 to Week 28
COMPLETED
0
0
24
45
Period B (OLE): From Week 16 to Week 28
NOT COMPLETED
0
0
2
6

Reasons for withdrawal

Reasons for withdrawal
Measure
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).
Period A: SAR442970
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
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).
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).
Period A (DB): Up to Week 16
Withdrawal by Subject
1
1
0
0
Period A (DB): Up to Week 16
Other
1
3
0
0
Period A (DB): Up to Week 16
Adverse Event
0
2
0
0
Period B (OLE): From Week 16 to Week 28
Adverse Event
0
0
0
1
Period B (OLE): From Week 16 to Week 28
Non-compliance with study schedule
0
0
0
1
Period B (OLE): From Week 16 to Week 28
Withdrawal by Subject
0
0
2
1
Period B (OLE): From Week 16 to Week 28
Other
0
0
0
2
Period B (OLE): From Week 16 to Week 28
Non-compliance with study drug
0
0
0
1

Baseline Characteristics

A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Period A: Placebo
n=28 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=58 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Total
n=86 Participants
Total of all reporting groups
Age, Continuous
37.0 years
STANDARD_DEVIATION 13.2 • n=41 Participants
36.3 years
STANDARD_DEVIATION 12.2 • n=1581 Participants
36.5 years
STANDARD_DEVIATION 12.5 • n=4626 Participants
Sex: Female, Male
Female
15 Participants
n=41 Participants
38 Participants
n=1581 Participants
53 Participants
n=4626 Participants
Sex: Female, Male
Male
13 Participants
n=41 Participants
20 Participants
n=1581 Participants
33 Participants
n=4626 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=41 Participants
1 Participants
n=1581 Participants
1 Participants
n=4626 Participants
Race (NIH/OMB)
Asian
3 Participants
n=41 Participants
0 Participants
n=1581 Participants
3 Participants
n=4626 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=41 Participants
3 Participants
n=1581 Participants
5 Participants
n=4626 Participants
Race (NIH/OMB)
White
16 Participants
n=41 Participants
50 Participants
n=1581 Participants
66 Participants
n=4626 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants
n=41 Participants
4 Participants
n=1581 Participants
11 Participants
n=4626 Participants

PRIMARY outcome

Timeframe: Week 16

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Period A: Placebo
n=23 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=48 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
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).
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).
Period A (DB Period): Percentage of Biologic and Small Molecule Immunosuppressive-Naïve Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16
39.1 percentage of participants
66.7 percentage of participants
—
—

SECONDARY outcome

Timeframe: Up to Week 16

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Period A: Placebo
n=23 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=48 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
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).
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).
Period A (DB Period): Time to Onset of Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)
113.00 days
Interval 29.0 to
NA indicates that the upper limit of the 90% confidence interval was not estimable due to insufficient number of participants achieving HiSCR50 by the end of the DB period.
29.00 days
Interval 17.0 to 29.0
—
—

SECONDARY outcome

Timeframe: Week 16

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Period A: Placebo
n=23 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=48 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
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).
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).
Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16
21.7 percentage of participants
54.2 percentage of participants
—
—

SECONDARY outcome

Timeframe: Week 16

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Period A: Placebo
n=23 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=48 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
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).
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).
Period A (DB Period): Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR90) at Week 16
8.7 percentage of participants
31.3 percentage of participants
—
—

SECONDARY outcome

Timeframe: Week 16

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Period A: Placebo
n=23 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=48 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
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).
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).
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
56.5 percentage of participants
83.3 percentage of participants
—
—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 16

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Period A: Placebo
n=23 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=48 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
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).
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).
Period A (DB Period): Change From Baseline at Week 16 in Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4)
-7.3 score on a scale
Standard Deviation 19.5
-18.1 score on a scale
Standard Deviation 18.6
—
—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 16

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Period A: Placebo
n=23 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=48 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
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).
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).
Period A (DB Period): Percentage of Participants Who Experienced a Flare Relative to Baseline at Week 16
30.4 percentage of participants
16.7 percentage of participants
—
—

SECONDARY outcome

Timeframe: Week 16

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Period A: Placebo
n=23 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=48 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
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).
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).
Period A (DB Period): Percentage of Participants Who Achieved International Hidradenitis Suppurativa Severity Score System (IHS4)-55 at Week 16
34.8 percentage of participants
64.6 percentage of participants
—
—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Period A: Placebo
n=28 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=58 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period B: Placebo-SAR442970
n=26 Participants
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).
Period B: SAR442970-SAR442970
n=51 Participants
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).
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)
Any TEAEs
15 Participants
45 Participants
14 Participants
30 Participants
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)
Any TESAEs
0 Participants
0 Participants
0 Participants
0 Participants
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)
Any TEAESIs
0 Participants
3 Participants
0 Participants
2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 16

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Period A: Placebo
n=15 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=32 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
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).
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).
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
40.0 percentage of participants
40.6 percentage of participants
—
—

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 4, 8, 10, 12 and 16 (Period A); Weeks 18, 20 and 28 (Period B)

Population: 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.

Blood samples were collected at specified timepoints for assessment of serum SAR442970 concentrations.

Outcome measures

Outcome measures
Measure
Period A: Placebo
n=58 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=25 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period B: Placebo-SAR442970
n=48 Participants
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).
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).
Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations
Baseline (Day 1)
0.00 nanogram per milliliter
Standard Deviation 0.00
—
—
—
Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations
Week 4
6451.21 nanogram per milliliter
Standard Deviation 2252.03
—
—
—
Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations
Week 8
7729.59 nanogram per milliliter
Standard Deviation 2957.15
—
—
—
Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations
Week 10
8091.69 nanogram per milliliter
Standard Deviation 5141.56
—
—
—
Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations
Week 12
9486.51 nanogram per milliliter
Standard Deviation 8715.72
—
—
—
Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations
Week 16
8844.81 nanogram per milliliter
Standard Deviation 5908.33
—
—
—
Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations
Week 18
—
4696.96 nanogram per milliliter
Standard Deviation 1941.04
7996.88 nanogram per milliliter
Standard Deviation 3716.46
—
Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations
Week 20
—
5693.20 nanogram per milliliter
Standard Deviation 2223.45
8339.58 nanogram per milliliter
Standard Deviation 4192.17
—
Period A (DB Period) + Period B (OLE Period): Serum SAR442970 Concentrations
Week 28
—
7291.30 nanogram per milliliter
Standard Deviation 3197.02
8513.07 nanogram per milliliter
Standard Deviation 6868.14
—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Period A: Placebo
n=25 Participants
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=58 Participants
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
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).
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).
Period B (OLE Period) + Period A+B (DB+OLE Period): Number of Participants With Anti-SAR442970 Antibody Response
18 Participants
45 Participants
—
—

Adverse Events

Period A: Placebo

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Period A: SAR442970

Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths

Period B: Placebo-SAR442970

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Period B: SAR442970-SAR442970

Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Period A: Placebo
n=28 participants at risk
Participants received SAR442970 matched placebo Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period A: SAR442970
n=58 participants at risk
Participants received SAR442970 150 mg Q2W via SC injection from Day 1 to Week 16 in Period A (DB period).
Period B: Placebo-SAR442970
n=26 participants at risk
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).
Period B: SAR442970-SAR442970
n=51 participants at risk
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).
Infections and infestations
Nasopharyngitis
10.7%
3/28 • Number of events 3 • 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.
19.0%
11/58 • Number of events 11 • 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.
0.00%
0/26 • 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.
2.0%
1/51 • Number of events 1 • 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.
Infections and infestations
Upper Respiratory Tract Infection
3.6%
1/28 • Number of events 1 • 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.
6.9%
4/58 • Number of events 4 • 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.
7.7%
2/26 • Number of events 3 • 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.
7.8%
4/51 • Number of events 4 • 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.
Metabolism and nutrition disorders
Hypertriglyceridaemia
7.1%
2/28 • Number of events 2 • 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.
3.4%
2/58 • Number of events 2 • 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.
0.00%
0/26 • 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.
0.00%
0/51 • 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.
Nervous system disorders
Headache
10.7%
3/28 • Number of events 3 • 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.
13.8%
8/58 • Number of events 16 • 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.
7.7%
2/26 • Number of events 2 • 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.
7.8%
4/51 • Number of events 5 • 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.
Skin and subcutaneous tissue disorders
Hidradenitis
3.6%
1/28 • Number of events 1 • 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.
5.2%
3/58 • Number of events 3 • 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.
7.7%
2/26 • Number of events 2 • 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.
3.9%
2/51 • Number of events 2 • 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.
Skin and subcutaneous tissue disorders
Pain Of Skin
0.00%
0/28 • 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.
1.7%
1/58 • Number of events 1 • 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.
0.00%
0/26 • 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.
5.9%
3/51 • Number of events 4 • 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.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/28 • 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.
5.2%
3/58 • Number of events 3 • 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.
0.00%
0/26 • 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.
2.0%
1/51 • Number of events 1 • 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.
General disorders
Injection Site Reaction
0.00%
0/28 • 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.
5.2%
3/58 • Number of events 3 • 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.
0.00%
0/26 • 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.
0.00%
0/51 • 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.
Injury, poisoning and procedural complications
Accidental Overdose
14.3%
4/28 • Number of events 4 • 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.
12.1%
7/58 • Number of events 7 • 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.
3.8%
1/26 • Number of events 1 • 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.
5.9%
3/51 • Number of events 3 • 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.

Additional Information

Trial Transparency Team

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Results disclosure agreements

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