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Proof-of-concept Study for SAR441344 in Relapsing Multiple Sclerosis

Sponsor
Sanofi (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04879628
Collaborator
(none)
129
Enrollment
48
Locations
4
Arms
33
Anticipated Duration (Months)
2.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions

Secondary Objective:

  • To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures

  • To evaluate the safety and tolerability of SAR441344

  • To evaluate pharmacokinetics of SAR441344

Condition or Disease Intervention/Treatment Phase
  • Drug: SAR441344 IV
  • Drug: placebo IV
  • Drug: SAR441344 SC
  • Drug: placebo SC
  • Drug: MRI contrast-enhancing preparations
 Phase 2

Detailed Description

The duration of each participant will be no longer than 116 weeks in both parts of the study, including 4 weeks of screening, at maximum 88 weeks of treatment and 24 weeks of follow-up.

Study Design

Study Type:
Interventional
Actual Enrollment :
129 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Part A is a 12-week, double-blind, placebo-controlled part; Part B is an open-label SAR441344 treatment part.Part A is a 12-week, double-blind, placebo-controlled part; Part B is an open-label SAR441344 treatment part.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis
Actual Study Start Date :
Jun 7, 2021
Anticipated Primary Completion Date :
Sep 22, 2022
Anticipated Study Completion Date :
Mar 7, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: IV SAR441344

SAR441344 IV

Drug: SAR441344 IV
Pharmaceutical form: Solution Route of administration: IV infusion

Drug: MRI contrast-enhancing preparations
Pharmaceutical form: Solution Route of administration: IV injection
Placebo Comparator: IV Placebo

Placebo IV

Drug: placebo IV
Pharmaceutical form: Solution Route of administration: IV infusion

Drug: MRI contrast-enhancing preparations
Pharmaceutical form: Solution Route of administration: IV injection
Experimental: SC SAR441344

SAR441344 SC

Drug: SAR441344 SC
Pharmaceutical form: Solution Route of administration: SC injection

Drug: MRI contrast-enhancing preparations
Pharmaceutical form: Solution Route of administration: IV injection
Placebo Comparator: SC Placebo

Placebo SC

Drug: placebo SC
Pharmaceutical form: Solution Route of administration: SC injection

Drug: MRI contrast-enhancing preparations
Pharmaceutical form: Solution Route of administration: IV injection

Outcome Measures

Primary Outcome Measures

  1. Number of new Gadolinium (Gd)-enhancing T1-hyperintense (GdE T1) lesions [At Week 12]

    measured by brain magnetic resonance imaging (MRI)

Secondary Outcome Measures

  1. Number of new or enlarging T2 lesions [At Week 12]

    measured by brain magnetic resonance imaging (MRI)

  2. Total number of GdE T1 lesions [At Week 12]

    Total number of GdE T1 lesions at Week 12

  3. Adverse events (AEs) and serious adverse events (SAEs) [Until Week 112]

    Number of participants with AEs and SAEs

  4. Antidrug antibodies (ADA) [Until Week 112]

    Number of participants with ADA

  5. Pharmacokinetic (PK) parameters: Cmax [Until Week 112]

    maximum concentration

  6. PK parameter: tmax [Until Week 112]

    time to Cmax

  7. PK parameter: AUC0-tau [Until Week 112]

    area under the curve over the dosing interval

  8. PK parameter: t1/2z [Until Week 112]

    elimination half-life

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:

  • Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.

  • The participant must have been diagnosed with RMS (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria.

  • The participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.

  • Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening.

  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

  • Capable of giving signed informed consent.

Exclusion criteria:

  • The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.

  • The participant has conditions or situations that would adversely affect participation in this study.

  • The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study.

  • History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.

  • Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule.

  • The participant has received any of the forbidden medications/treatments within the specified time frame before any baseline assessment.

  • The participant has taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit.

  • The participant has an EDSS score >5.5 at the first screening visit.

  • The participant has had a relapse in the 30 days prior to randomization.

  • Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.

  • Abnormal laboratory test(s) at Screening.

  • Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (anti-HBc Ab) at screening or within 3 months prior to first dose of study intervention.

  • Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigational Site Number :8400007 Phoenix Arizona United States 85032
2 Investigational Site Number :8400001 Tampa Florida United States 33612
3 Investigational Site Number :8400004 Charlotte North Carolina United States 28204
4 Investigational Site Number :8400002 Philadelphia Pennsylvania United States 19107
5 Investigational Site Number :8400003 Milwaukee Wisconsin United States 53215
6 Investigational Site Number :8400006 Milwaukee Wisconsin United States 53226
7 Investigational Site Number :1000002 Pleven Bulgaria 5800
8 Investigational Site Number :1000003 Sofia Bulgaria 1113
9 Investigational Site Number :1000001 Sofia Bulgaria 1407
10 Investigational Site Number :1240001 Gatineau Quebec Canada J8Y 1W2
11 Investigational Site Number :2030003 Brno Czechia 65691
12 Investigational Site Number :2030002 Hradec Kralove Czechia 50005
13 Investigational Site Number :2030001 Jihlava Czechia 58633
14 Investigational Site Number :2030005 Ostrava - Poruba Czechia 70852
15 Investigational Site Number :2030004 Teplice Czechia 415 29
16 Investigational Site Number :2500007 Ars-Laquenexy France 57085
17 Investigational Site Number :2500003 Caen France 14033
18 Investigational Site Number :2500006 Calais France 62107
19 Investigational Site Number :2500002 Dijon France 21079
20 Investigational Site Number :2500004 Marseille France 13003
21 Investigational Site Number :2760003 Dresden Germany 01307
22 Investigational Site Number :2760001 Gießen Germany 35385
23 Investigational Site Number :2760012 Leipzig Germany 04103
24 Investigational Site Number :2760004 Münster Germany 48149
25 Investigational Site Number :2760011 Sande Germany 26452
26 Investigational Site Number :2760005 Würzburg Germany 97070
27 Investigational Site Number :6430002 Kazan Russian Federation 420021
28 Investigational Site Number :6430007 Moscow Russian Federation 117556
29 Investigational Site Number :6430006 Moscow Russian Federation 117997
30 Investigational Site Number :6430001 Moscow Russian Federation 127015
31 Investigational Site Number :6430004 Saint-Petersburg Russian Federation 197110
32 Investigational Site Number :6430003 St-Petersburg Russian Federation 194044
33 Investigational Site Number :6430005 St-Petersburg Russian Federation 197022
34 Investigational Site Number :6430008 Tyumen Russian Federation 625000
35 Investigational Site Number :7240004 Barcelona Barcelona [Barcelona] Spain 08035
36 Investigational Site Number :7240003 Pamplona Navarra Spain 31008
37 Investigational Site Number :7240002 Vigo Pontevedra [Pontevedra] Spain 36312
38 Investigational Site Number :7920004 Eskisehir Turkey
39 Investigational Site Number :7920003 Istanbul Turkey
40 Investigational Site Number :7920001 Izmit Turkey 41380
41 Investigational Site Number :7920002 Mersin Turkey 33070
42 Investigational Site Number :8040006 Dnipro Ukraine 49005
43 Investigational Site Number :8040010 Dnipro Ukraine 49069
44 Investigational Site Number :8040008 Ivano-Frankivsk Ukraine 76493
45 Investigational Site Number :8040002 Kharkiv Ukraine 61103
46 Investigational Site Number :8040004 Lviv Ukraine 79013
47 Investigational Site Number :8040003 Odesa Ukraine 65025
48 Investigational Site Number :8040005 Vinnytsia Ukraine 21050

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT04879628
Other Study ID Numbers:
  • ACT16877
  • 2020-004785-19
  • U1111-1260-3962
First Posted:
May 10, 2021
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 6, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis

Study Results

No Results Posted as of Jul 7, 2022