frexalimab (SAR441344) / Sanofi 
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10 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
frexalimab (SAR441344) / Sanofi
FREXALT, NCT06141473: Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

Recruiting
3
1400
Europe, Canada, Japan, US, RoW
Frexalimab, Teriflunomide, Placebo infusion, Placebo tablet, MRI contrast-enhancing agents, Cholestyramine, Activated charcoal
Sanofi
Multiple Sclerosis
05/27
05/27
FREVIVA, NCT06141486: Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

Recruiting
3
858
Europe, Canada, Japan, US, RoW
Frexalimab, Placebo, MRI contrast-enhancing agents
Sanofi
Multiple Sclerosis
12/26
03/28
2020-004785-19: Proof-of-concept study for SAR441344 in relapsing multiple sclerosis

Ongoing
2
160
Europe, RoW
SAR441344, SAR441344, Solution for injection
Sanofi-Aventis Recherche et Développement, Sanofi-Aventis Recherche et Développement
Multiple sclerosis, Multiple sclerosis, Diseases [C] - Nervous System Diseases [C10]
 
 
2021-001567-25: Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus Eficacia y seguridad de SAR441344 para el tratamiento del Lupus Eritematoso Sistémico.

Not yet recruiting
2
166
Europe
SAR441344, SAR441344, Solution for injection
Sanofi-Aventis Recherche et Développement, SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT, Sanofi-Aventis Recherche et Développement, Sanofi-aventis Recherche & Développement
Systemic lupus erythematosus Lupus Eritematoso Sistémico, Systemic lupus erythematosus Lupus Eritematoso Sistémico, Diseases [C] - Musculoskeletal Diseases [C05]
 
 
ACT16877, NCT04879628 / 2020-004785-19: Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis

Active, not recruiting
2
129
Europe, Canada, US, RoW
SAR441344 IV, placebo IV, SAR441344 SC, placebo SC, MRI contrast-enhancing preparations
Sanofi, Sanofi-Aventis Recherche et Développement
Multiple Sclerosis
09/22
08/27
phaethuSA, NCT04572841 / 2020-000511-77: Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)

Completed
2
84
Europe, Canada, US, RoW
SAR441344, Placebo
Sanofi
Sjögren's Syndrome, Sjogren's Syndrome
11/23
02/24
RESULT, NCT06500702: A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

Not yet recruiting
2
84
NA
frexalimab, SAR442970, rilzabrutinib, placebo
Sanofi
Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
12/26
02/28
APATURA, NCT05039840: Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus

Recruiting
2
116
Europe, US, RoW
SAR441344 IV, SAR441344 SC, Placebo IV, Placebo SC
Sanofi
Systemic Lupus Erythematosus
09/25
11/26
FABULINUS, NCT06111586: FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy

Recruiting
2
192
Europe, Canada, US
Frexalimab, Placebo, Insulin
Sanofi
Type 1 Diabetes Mellitus
04/27
10/28
NCT05845996: Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects

Completed
1
56
US
SAR441344, placebo, Keyhole limpet hemocyanin
Sanofi
Healthy Volunteers
04/20
04/20

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