Trial · NCT04781816

Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus

NCT04781816, Phase 2, Completed, Sanofi; results first posted 2024-06-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus. Trials, record NCT04781816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04781816

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
NCT number: NCT04781816
Status: Completed
Phases: Phase 2
Enrollment: 78 participants, actual
Lead sponsor: Sanofi
Conditions: Cutaneous Lupus Erythematosus
Interventions: SAR443122, Placebo
First posted: 2021-03-04
Last updated: 2025-08-27
Other registries' IDs: eudract:2020-004703-14
Results first posted: 2024-06-24

Source ClinicalTrials.gov

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12	Baseline (Day 1) and Week 12	The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering 2 dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges for 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. Higher score indicates a more severe skin disease. Baseline was defined as the Day 1 assessment value.
Secondary	Percentage of Participants With Physician's Global Assessment of Disease Activity (PhysGA- Disease Activity) of 0 or 1 (Disease Free or Almost Disease Free) at Week 12	Week 12	The PhysGA- disease activity is a 5 point-Lickert scale instrument designed to assess physician-reported disease activity. The investigators were asked the following question "How active would you say your patient's cutaneous lupus erythematosus is currently?" The total score on scale ranges from 0 (not active at all) to 4 (extremely active). Higher score indicates a more severe skin disease.
Secondary	Change From Baseline in Participants Reported Daily Worst Itch Using Peak Pruritus Numerical Rating Scale (Itch-NRS) at Week 12	Baseline (Day 1) and Week 12	The Peak Pruritus NRS (itch-NRS) is a single item patient reported outcomes (PRO) tool that participants used to report the intensity of their pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 (no itch) to 10 (worst itch imaginable) NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". The total score on scale ranges from 0 (no itch) to 10 (worst itch imaginable). Higher score indicates a more severe skin disease. Baseline was defined as the average of daily non-missing scores obtained during the week prior to Day 1.
Secondary	Change From Baseline in Participants Reported Daily Worst Pain Using Peak Pain Numerical Rating Scale (Pain-NRS) at Week 12	Baseline (Day 1) and Week 12	The Peak Pain NRS (Pain-NRS) is a single item PRO tool that participants used to report the intensity of their CLE-related pain (skin, oral, genital) during a daily recall period. Participants were asked to rate their worst pain on a 0 (no pain) to 10 (worst pain imaginable) NRS by answering the following question: "On a scale of 0 to 10, with 0 being 'no pain' and 10 being the 'worst pain imaginable', how would you rate your pain at the worst moment due to your lupus during the previous 24 hours?". The total score on scale ranges from 0 (no pain) to 10 (worst pain imaginable). Higher score indicates a more severe skin disease. Baseline was defined as the average of daily non-missing scores obtained during the week prior to Day 1.
Secondary	Percentage of CLASI-A50 and CLASI-A75 Responders at Week 12	Week 12	The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering 2 dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges for 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. Higher score indicates a more severe skin disease. The CLASI-A50/75 responder was defined as a participant who achieved a decrease by at least 50%/75% of CLASI-A sub-score from baseline.
Secondary	Change From Baseline in CLASI Components' Score Over Time	Baseline (Day 1) and Weeks 4, 8, 12, and 16	The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering two dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. CLASI-D disease damage covers the domains: dyspigmentation, scarring/atrophy/panniculitis, and clinically judged scarring of the scalp (including scarring alopecia). Scale ranges 0 (absence of disease damage) to 56 (severe disease damage) using the parameters of dyspigmentation and scarring. For CLASI-A and CLASI-D, higher score indicates a more severe skin disease. Change from baseline in CLASI components' score are reported. Baseline was defined as the Day 1 assessment value.
Secondary	Percentage of Participants With Investigator's Global Assessment of Cutaneous Lupus Erythematosus (IGA-CLE) Score of 0 or 1 (Clear Or Almost Clear) at Week 12	Week 12	The IGA-CLE is a clinician reported outcome (ClinRO) that allows for clinicians to assess the overall disease activity of CLE using a 5-point scale: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). The severity of CLE is determined by descriptions of a combination of 3 plaque characteristics: erythema, scale, elevation. Erythema is the primary characteristic that influenced the rating, with other characteristics considered secondarily. Telangiectatic change is not considered in the rating. The assessment did not require the presence of all 4 characteristics, the severity was averaged over the observed characteristics. The total score on scale ranges from 0 to 4. Higher score indicates a more severe skin disease.
Secondary	Change From Baseline to Week 12 in the Oral Health Impact Profile 14-Item Version (OHIP-14) for Participants With Oral Lesions at Baseline	Baseline (Day 1) and Week 12	The OHIP-14 is a PRO questionnaire that is composed of 14 items that assess 7 different dimensions, considering the perception of the individual in relation to the impact of oral conditions in the physical, psychological and social well-being in the last month. Each of the 14 items has a set of possible answers distributed in a Likert scale (0 = never, 1 = hardly ever. 2 = occasionally 3 = fairly often, 4 = very often), which represents the frequency that the individual perceives the impact of oral health on 7 dimensions: functional limitation (2 items), physical pain (2 items), psychological discomfort (2 items), physical disability (2 items), psychological disability (2 items), social disability (2 items) and handicap (2 items). The OHIP-14 scores range from 0 to 56 and are calculated by summing the ordinal values for 14 items. Domain scores range from 0 to 8. Higher OHIP-14 scores indicate worse oral-health-related quality of life. Baseline was defined as Day 1 assessment value.
Secondary	Change From Baseline in SKINDEX-29+3 Total Score at Week 12	Baseline (Day 1) and Week 12	Skindex 29+3 is a PRO measure designed to assess the effects of skin disease on participants' health-related quality of life in adults. It contains the following domains: emotions (10 items), symptoms (7 items), functioning (12 items), lupus-specific issues (3 questions), and 1 item about treatment that is not part of the total score. Recall period is during the past week. Each item is rated on a 5-point Likert scale (never, rarely, sometimes, often, all the time). These responses are then transformed to a linear scale ranging from 0 to 100 in 25-point increments, with 100 representing maximal disability. The total score is the average of participants' responses to items in a given domain, ranging from 0 to 100, where higher scores indicate a greater impact on the health-related quality of life. Baseline was defined as the Day 1 assessment value.
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESIs)	From first dose of study treatment (Day 1) up to end of study (Week 16)	An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as the adverse events that occurred from the time of the first IMP administration up to the end of study visit. Serious adverse events (SAE): Any AE 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, was a medically important event. An AESI: an AE (serious or nonserious) 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.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12	Baseline (Day 1) and Week 12	Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement. Only participants with data collected at Week 12 are reported.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Physician's Global Assessment of Disease Activity (PhysGA- Disease Activity) of 0 or 1 (Disease Free or Almost Disease Free) at Week 12	Week 12	Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Participants Reported Daily Worst Itch Using Peak Pruritus Numerical Rating Scale (Itch-NRS) at Week 12	Baseline (Day 1) and Week 12	Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement. Only participants with data collected at Week 12 are reported.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Participants Reported Daily Worst Pain Using Peak Pain Numerical Rating Scale (Pain-NRS) at Week 12	Baseline (Day 1) and Week 12	Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement. Only participants with data collected at Week 12 are reported.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of CLASI-A50 and CLASI-A75 Responders at Week 12	Week 12	Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement.	percentage of responders	NUMBER
SECONDARY	Change From Baseline in CLASI Components' Score Over Time	Baseline (Day 1) and Weeks 4, 8, 12, and 16	Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement. Only participants with data collected at Weeks 4, 8, 12, and 16 for each specified category are reported.	score on a scale	MEAN
SECONDARY	Percentage of Participants With Investigator's Global Assessment of Cutaneous Lupus Erythematosus (IGA-CLE) Score of 0 or 1 (Clear Or Almost Clear) at Week 12	Week 12	Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement. Only participants with data collected at Week 12 are reported.	percentage of participants	NUMBER
SECONDARY	Change From Baseline to Week 12 in the Oral Health Impact Profile 14-Item Version (OHIP-14) for Participants With Oral Lesions at Baseline	Baseline (Day 1) and Week 12	Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement. Only participants with data collected at Week 12 are reported.	score on a scale	MEAN
SECONDARY	Change From Baseline in SKINDEX-29+3 Total Score at Week 12	Baseline (Day 1) and Week 12	Efficacy population included all randomized participants exposed to the IMP, with available Baseline assessment of the CLASI-A who actually received at least 1 complete dose of IMP and with at least 1 post IMP administration measurement.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESIs)	From first dose of study treatment (Day 1) up to end of study (Week 16)	Safety population included all randomized participants exposed to the IMP (regardless of the amount of treatment administered).	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group174

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12	Placebo		-37.05	Standard Error 5.31	percent change
Percent Change From Baseline in Cutaneous Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Sub-Score at Week 12	SAR443122		-42.76	Standard Error 5.42	percent change
Percentage of Participants With Physician's Global Assessment of Disease Activity (PhysGA- Disease Activity) of 0 or 1 (Disease Free or Almost Disease Free) at Week 12	Placebo		32.5		percentage of participants
Percentage of Participants With Physician's Global Assessment of Disease Activity (PhysGA- Disease Activity) of 0 or 1 (Disease Free or Almost Disease Free) at Week 12	SAR443122		44.74		percentage of participants
Change From Baseline in Participants Reported Daily Worst Itch Using Peak Pruritus Numerical Rating Scale (Itch-NRS) at Week 12	Placebo		-0.62	Standard Error 0.37	score on a scale
Change From Baseline in Participants Reported Daily Worst Itch Using Peak Pruritus Numerical Rating Scale (Itch-NRS) at Week 12	SAR443122		-2.16	Standard Error 0.39	score on a scale
Change From Baseline in Participants Reported Daily Worst Pain Using Peak Pain Numerical Rating Scale (Pain-NRS) at Week 12	Placebo		-0.93	Standard Error 0.32	score on a scale
Change From Baseline in Participants Reported Daily Worst Pain Using Peak Pain Numerical Rating Scale (Pain-NRS) at Week 12	SAR443122		-1.72	Standard Error 0.34	score on a scale
Percentage of CLASI-A50 and CLASI-A75 Responders at Week 12	Placebo	CLASI-A50	45		percentage of responders
Percentage of CLASI-A50 and CLASI-A75 Responders at Week 12	SAR443122	CLASI-A50	44.74		percentage of responders

1 to 10 of 174Source ClinicalTrials.gov

See all 174 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	40
Overall Study	STARTED	SAR443122	38
Overall Study	COMPLETED	Placebo	38
Overall Study	COMPLETED	SAR443122	35
Overall Study	NOT COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	SAR443122	3

Source ClinicalTrials.gov

Adverse events126

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Neutropenia	Blood and lymphatic system disorders	Placebo	1	40	1
other	Neutropenia	Blood and lymphatic system disorders	SAR443122	0	38	0
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	1	40	1
other	Thrombocytopenia	Blood and lymphatic system disorders	SAR443122	0	38	0
other	Coronary Artery Stenosis	Cardiac disorders	Placebo	1	40	1
other	Coronary Artery Stenosis	Cardiac disorders	SAR443122	0	38	0
other	Vertigo	Ear and labyrinth disorders	Placebo	1	40	1
other	Vertigo	Ear and labyrinth disorders	SAR443122	0	38	0
other	Maculopathy	Eye disorders	Placebo	0	40	0
other	Maculopathy	Eye disorders	SAR443122	1	38	1

1 to 10 of 126Source ClinicalTrials.gov

See all 126 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	40
Total, all-cause mortality	SAR443122	0	38
Total, other adverse events	Placebo	18	40
Total, other adverse events	SAR443122	22	38
Total, serious adverse events	Placebo	1	40
Total, serious adverse events	SAR443122	0	38

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
SAR443122 vs Placebo: deaths from any cause	Trial comparisons
SAR443122 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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