Dienstag, 27. Juli 2021
Navigation öffnen
Anzeige:
Darzalex
Darzalex
 
JOURNAL ONKOLOGIE – STUDIE
HERCULES

Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)

Rekrutierend

NCT-Nummer:
NCT04411641

Studienbeginn:
September 2020

Letztes Update:
14.07.2021

Wirkstoff:
Tolebrutinib, Placebo to match Tolebrutinib

Indikation (Clinical Trials):
Neoplasm Metastasis, Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive, Sclerosis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Sanofi

Collaborator:
-

Studienleiter

Clinical Sciences & Operations
Study Director
Sanofi

Kontakt

Trial Transparency email recommended (Toll free number for US & Canada)
Kontakt:
Phone: 800-633-1610
Phone (ext.): option 6
E-Mail: Contact-US@sanofi.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 223)

Investigational Site Number 2760009
Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760001
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760012
Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760002
Gießen
(Hessen)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760006
Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760008
Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Investigational Site Number 2760004
Rostock
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Investigational Site Number 8400013
35233 Birmingham
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400070
91006 Arcadia
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400045
90806 Long Beach
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400088
90502 Torrance
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400128
81621 Basalt
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400025
80528 Fort Collins
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400029
33487 Boca Raton
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400027
34105 Naples
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400001
33609-4052 Tampa
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400006
33612 Tampa
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400003
31406 Savannah
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400011
60062 Northbrook
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400072
02111 Boston
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400033
48867 Owosso
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400019
63131 Saint Louis
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400117
89106 Las Vegas
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400042
11794 Stony Brook
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400005
27607 Raleigh
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400002
45417 Dayton
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400010
40382 Westerville
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400069
29650 Greer
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400024
29651-1817 Greer
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400087
38018 Cordova
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400035
37064 Franklin
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400036
78258 San Antonio
United StatesRekrutierend» Google-Maps
Investigational Site Number 8400099
99202 Spokane
United StatesRekrutierend» Google-Maps
Investigational Site Number 0320007
Buenos Aires
ArgentinaRekrutierend» Google-Maps
Investigational Site Number 0320001
C1061 Caba
ArgentinaRekrutierend» Google-Maps
Investigational Site Number 0320002
1012 Capital Federal
ArgentinaRekrutierend» Google-Maps
Investigational Site Number 0320006
Córdoba
ArgentinaRekrutierend» Google-Maps
Investigational Site Number 0320005
T4000AXL San Miguel De Tucuman
ArgentinaRekrutierend» Google-Maps
Investigational Site Number 0360001
3065 Fitzroy
AustraliaRekrutierend» Google-Maps
Investigational Site Number 0360006
3081 Heidelberg West
AustraliaRekrutierend» Google-Maps
Investigational Site Number 0360004
7001 Hobart
AustraliaRekrutierend» Google-Maps
Investigational Site Number 0360002
Kent Town
AustraliaRekrutierend» Google-Maps
Investigational Site Number 0360003
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps
Investigational Site Number 0400003
Innsbruck
AustriaRekrutierend» Google-Maps
Investigational Site Number 1120004
210009 Vitebsk
BelarusRekrutierend» Google-Maps
Investigational Site Number 1120005
210037 Vitebsk
BelarusRekrutierend» Google-Maps
Investigational Site Number 0560007
1200 Bruxelles
BelgiumRekrutierend» Google-Maps
Investigational Site Number 0560003
Edegem
BelgiumRekrutierend» Google-Maps
Investigational Site Number 0560006
3000 Leuven
BelgiumRekrutierend» Google-Maps
Investigational Site Number 0560008
Liège
BelgiumRekrutierend» Google-Maps
Investigational Site Number 0560001
3900 Pelt
BelgiumRekrutierend» Google-Maps
Investigational Site Number 1000002
5800 Pleven
BulgariaRekrutierend» Google-Maps
Investigational Site Number 1000005
Plovdiv
BulgariaRekrutierend» Google-Maps
Investigational Site Number 1000004
1113 Sofia
BulgariaRekrutierend» Google-Maps
Investigational Site Number 1000008
1407 Sofia
BulgariaRekrutierend» Google-Maps
Investigational Site Number 1000001
1431 Sofia
BulgariaRekrutierend» Google-Maps
Investigational Site Number 1000006
1431 Sofia
BulgariaRekrutierend» Google-Maps
Investigational Site Number 1000009
1680 Sofia
BulgariaRekrutierend» Google-Maps
Investigational Site Number 1240006
J8Y 1W2 Gatineau
CanadaRekrutierend» Google-Maps
Investigational Site Number 1240005
J4V 2J2 Greenfield Park
CanadaRekrutierend» Google-Maps
Investigational Site Number 1240015
Montréal
CanadaRekrutierend» Google-Maps
Investigational Site Number 1240008
Toronto
CanadaRekrutierend» Google-Maps
Investigational Site Number 1560004
Changchun
ChinaRekrutierend» Google-Maps
Investigational Site Number 1560005
610041 Chengdu
ChinaRekrutierend» Google-Maps
Investigational Site Number 1560019
Chongqing
ChinaRekrutierend» Google-Maps
Investigational Site Number 1560001
510630 Guangzhou
ChinaRekrutierend» Google-Maps
Investigational Site Number 1560007
Hangzhou
ChinaRekrutierend» Google-Maps
Investigational Site Number 1560014
Shijia Zhuang
ChinaRekrutierend» Google-Maps
Investigational Site Number 1560017
710038 Xi'An
ChinaRekrutierend» Google-Maps
Investigational Site Number 2030002
65691 Brno
CzechiaRekrutierend» Google-Maps
Investigational Site Number 2030004
50005 Hradec Kralove
CzechiaRekrutierend» Google-Maps
Investigational Site Number 2030001
58633 Jihlava
CzechiaRekrutierend» Google-Maps
Investigational Site Number 2030010
70852 Ostrava - Poruba
CzechiaRekrutierend» Google-Maps
Investigational Site Number 2030005
12808 Praha 2
CzechiaRekrutierend» Google-Maps
Investigational Site Number 2030003
415 29 Teplice
CzechiaRekrutierend» Google-Maps
Investigational Site Number 2080001
Esbjerg
DenmarkRekrutierend» Google-Maps
Investigational Site Number 2080004
Odense
DenmarkRekrutierend» Google-Maps
Investigational Site Number 2460003
00180 Helsinki
FinlandRekrutierend» Google-Maps
Investigational Site Number 2460001
33520 Tampere
FinlandRekrutierend» Google-Maps
Investigational Site Number 2460002
20520 Turku
FinlandRekrutierend» Google-Maps
Investigational Site Number 2500011
69500 Bron
FranceRekrutierend» Google-Maps
Investigational Site Number 2500005
63003 Clermont Ferrand
FranceRekrutierend» Google-Maps
Investigational Site Number 2500015
95500 Gonesse
FranceRekrutierend» Google-Maps
Investigational Site Number 2500009
59037 Lille
FranceRekrutierend» Google-Maps
Investigational Site Number 2500006
34295 Montpellier
FranceRekrutierend» Google-Maps
Investigational Site Number 2500008
54035 Nancy
FranceRekrutierend» Google-Maps
Investigational Site Number 2500010
44093 Nantes Cedex 1
FranceRekrutierend» Google-Maps
Investigational Site Number 2500017
30029 Nimes
FranceRekrutierend» Google-Maps
Investigational Site Number 2500007
75019 Paris
FranceRekrutierend» Google-Maps
Investigational Site Number 2500003
35033 Rennes
FranceRekrutierend» Google-Maps
Investigational Site Number 2500001
67098 Strasbourg
FranceRekrutierend» Google-Maps
Investigational Site Number 2500012
Toulouse
FranceRekrutierend» Google-Maps
Investigational Site Number 3000006
11535 Athens
GreeceRekrutierend» Google-Maps
Investigational Site Number 3000002
12462 Haidari
GreeceRekrutierend» Google-Maps
Investigational Site Number 3000004
Larissa
GreeceRekrutierend» Google-Maps
Investigational Site Number 3000003
546 36 Thessaloniki
GreeceRekrutierend» Google-Maps
Investigational Site Number 3000005
57010 Thessaloniki
GreeceRekrutierend» Google-Maps
Investigational Site Number 3480007
1135 Budapest
HungaryRekrutierend» Google-Maps
Investigational Site Number 3480004
Budapest
HungaryRekrutierend» Google-Maps
Investigational Site Number 3480002
7623 Pécs
HungaryRekrutierend» Google-Maps
Investigational Site Number 3480006
2800 Tatabánya
HungaryRekrutierend» Google-Maps
Investigational Site Number 3560007
122001 Gurgaon
IndiaRekrutierend» Google-Maps
Investigational Site Number 3560003
122002 Gurgaon
IndiaRekrutierend» Google-Maps
Investigational Site Number 3560004
Mangaluru
IndiaRekrutierend» Google-Maps
Investigational Site Number 3560002
New Delhi
IndiaRekrutierend» Google-Maps
Investigational Site Number 3760002
Ashkelon
IsraelRekrutierend» Google-Maps
Investigational Site Number 3760003
31096 Haifa
IsraelRekrutierend» Google-Maps
Investigational Site Number 3760008
Jerusalem
IsraelRekrutierend» Google-Maps
Investigational Site Number 3760001
Tel HaShomer
IsraelRekrutierend» Google-Maps
Investigational Site Number 3760004
13100 Zefat
IsraelRekrutierend» Google-Maps
Investigational Site Number 3800007
09126 Cagliari
ItalyRekrutierend» Google-Maps
Investigational Site Number 3800013
L'Aquila
ItalyRekrutierend» Google-Maps
Investigational Site Number 3800004
20122 Milano
ItalyRekrutierend» Google-Maps
Investigational Site Number 3800010
20133 Milano
ItalyRekrutierend» Google-Maps
Investigational Site Number 3800005
00152 Roma
ItalyRekrutierend» Google-Maps
Investigational Site Number 3800009
00168 Roma
ItalyRekrutierend» Google-Maps
Investigational Site Number 3920016
Chiba-Shi
JapanRekrutierend» Google-Maps
Investigational Site Number 3920018
Kawagoe-Shi
JapanRekrutierend» Google-Maps
Investigational Site Number 3920004
Moriguchi
JapanRekrutierend» Google-Maps
Investigational Site Number 3920005
Niigata-Shi
JapanRekrutierend» Google-Maps
Investigational Site Number 3920001
Osaka-Shi
JapanRekrutierend» Google-Maps
Investigational Site Number 4400003
50161 Kaunas
LithuaniaRekrutierend» Google-Maps
Investigational Site Number 4400002
92288 Klaipeda
LithuaniaRekrutierend» Google-Maps
Investigational Site Number 4400001
08661 Vilnius
LithuaniaRekrutierend» Google-Maps
Investigational Site Number 5280001
1081 GN Amsterdam
NetherlandsRekrutierend» Google-Maps
Investigational Site Number 5280003
4818 CK Breda
NetherlandsRekrutierend» Google-Maps
Investigational Site Number 5280006
Groningen
NetherlandsRekrutierend» Google-Maps
Investigational Site Number 5280002
Sittard
NetherlandsRekrutierend» Google-Maps
Investigational Site Number 5780003
5021 Bergen
NorwayRekrutierend» Google-Maps
Investigational Site Number 5780002
7800 Namsos
NorwayRekrutierend» Google-Maps
Investigational Site Number 6160003
85-796 Bydgoszcz
PolandRekrutierend» Google-Maps
Investigational Site Number 6160002
40-571 Katowice
PolandRekrutierend» Google-Maps
Investigational Site Number 6160007
40-684 Katowice
PolandRekrutierend» Google-Maps
Investigational Site Number 6160004
40-686 Katowice
PolandRekrutierend» Google-Maps
Investigational Site Number 6160008
62-064 Plewiska
PolandRekrutierend» Google-Maps
Investigational Site Number 6160006
01-684 Warszawa
PolandRekrutierend» Google-Maps
Investigational Site Number 6160001
Łódź
PolandRekrutierend» Google-Maps
Investigational Site Number 6200001
Braga
PortugalRekrutierend» Google-Maps
Investigational Site Number 6200002
4464-513 Matosinhos
PortugalRekrutierend» Google-Maps
Investigational Site Number 6420008
022328 Bucuresti
RomaniaRekrutierend» Google-Maps
Investigational Site Number 6420004
115100 Campulung
RomaniaRekrutierend» Google-Maps
Investigational Site Number 6420006
400012 Cluj-Napoca
RomaniaRekrutierend» Google-Maps
Investigational Site Number 6420003
900123 Constanta
RomaniaRekrutierend» Google-Maps
Investigational Site Number 6420013
410154 Oradea
RomaniaRekrutierend» Google-Maps
Investigational Site Number 6420005
550052 Sibiu
RomaniaRekrutierend» Google-Maps
Investigational Site Number 6420001
540136 Targu Mures
RomaniaRekrutierend» Google-Maps
Investigational Site Number 6420002
300736 Timisoara
RomaniaRekrutierend» Google-Maps
Investigational Site Number 6430003
420021 Kazan
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430017
610998 Kirov
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430024
660029 Krasnoyarsk
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430002
125367 Moscow
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430013
127015 Moscow
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430021
603137 Nizhny Novgorod
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430006
603155 Nizhny Novgorod
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430005
630087 Novosibirsk
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430007
357538 Pyatigorsk
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430016
344022 Rostov-On-Don
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430004
197110 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430009
443095 Samara
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430019
430032 Saransk
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430014
214018 Smolensk
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430011
197022 St-Petersburg
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 6430012
625000 Tyumen
Russian FederationRekrutierend» Google-Maps
Investigational Site Number 7240013
08035 Barcelona
SpainRekrutierend» Google-Maps
Investigational Site Number 7240016
08036 Barcelona
SpainRekrutierend» Google-Maps
Investigational Site Number 7240008
14004 Córdoba
SpainRekrutierend» Google-Maps
Investigational Site Number 7240012
20014 Donostia
SpainRekrutierend» Google-Maps
Investigational Site Number 7240015
25198 Lleida / Lleida
SpainRekrutierend» Google-Maps
Investigational Site Number 7240005
28007 Madrid
SpainRekrutierend» Google-Maps
Investigational Site Number 7240002
28034 Madrid
SpainRekrutierend» Google-Maps
Investigational Site Number 7240003
28040 Madrid
SpainRekrutierend» Google-Maps
Investigational Site Number 7240004
28222 Majadahonda
SpainRekrutierend» Google-Maps
Investigational Site Number 7240010
30120 Murcia
SpainRekrutierend» Google-Maps
Investigational Site Number 7240009
29010 Málaga
SpainRekrutierend» Google-Maps
Investigational Site Number 7240001
28223 Pozuelo De Alarcón
SpainRekrutierend» Google-Maps
Investigational Site Number 7240014
17190 Salt
SpainRekrutierend» Google-Maps
Investigational Site Number 7240007
41009 Sevilla
SpainRekrutierend» Google-Maps
Investigational Site Number 7240011
46026 Valencia
SpainRekrutierend» Google-Maps
Investigational Site Number 7920005
Eskisehir
TurkeyRekrutierend» Google-Maps
Investigational Site Number 7920002
34098 Istanbul
TurkeyRekrutierend» Google-Maps
Investigational Site Number 7920007
34785 Istanbul
TurkeyRekrutierend» Google-Maps
Investigational Site Number 7920001
41380 Izmit
TurkeyRekrutierend» Google-Maps
Investigational Site Number 8040008
58000 Chernivtsi
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040016
58023 Chernivtsi
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040003
49005 Dnipro
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040010
76018 Ivano-Frankivsk
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040007
61068 Kharkiv
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040011
61103 Kharkiv
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040012
61103 Kharkiv
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040013
03115 Kyiv
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040005
43005 Lutsk
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040009
79010 Lviv
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040004
79013 Lviv
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040002
65025 Odesa
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040006
21050 Vinnitsa
UkraineRekrutierend» Google-Maps
Investigational Site Number 8040014
10002 Zhytormyr
UkraineRekrutierend» Google-Maps
Investigational Site Number 8260001
Cardiff
United KingdomRekrutierend» Google-Maps
Investigational Site Number 8260003
Exeter
United KingdomRekrutierend» Google-Maps
Investigational Site Number 8260014
Newcastle Upon Tyne
United KingdomRekrutierend» Google-Maps
Investigational Site Number 8260008
Plymouth
United KingdomRekrutierend» Google-Maps
Investigational Site Number 8260005
Tooting
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Study duration will vary per participant in this event driven trial with a treatment duration

of approximately 24 to 48 months.

Participants completing the treatment period will be proposed to enroll in a separate long

term safety study.

Ein-/Ausschlusskriterien

Inclusion criteria :

- 18 to 60 years of age inclusive

- Diagnosis of nonrelapsing secondary progressive multiple sclerosis according to the

2017 McDonald criteria

- Expanded disability status scale (EDSS) between 3.0 to 6.5 points inclusive, at

screening

- The participant must have documented evidence of disability progression observed

during the 12 months before screening

- Absence of clinical relapses for at least 24 months

- Contraceptive use by men or women should be consistent with local regulations

regarding the methods of contraception for those participating in clinical studies

- A female participant is eligible to participate if she is not pregnant or

breastfeeding, and at least one of the following conditions applies:

- Is not a WOCBP OR

- Is a WOCBP and agrees to use an acceptable contraceptive method

Exclusion criteria:

- The participant has conditions that would adversely affect study participation such as

short life expectancy.

- History of organ transplant.

- Evidence of infection with human immuodeficiency virus (HIV), progressive multifocal

leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or

other active infections that would adversely affect study participation.

- History of malignancy within 5 years prior to screening.

- History of alcohol or drug abuse within 1 year prior to screening.

- Hospitalized for psychiatric disease within 2 years prior to screening.

- Clinically significant laboratory abnormalities (including evidence of liver injury)

or electrocardiogram abnormalities at screening

- Bleeding disorder, known platelet dysfunction or platelet count <150 000/μL at

screening.

- A history of significant bleeding event within 6 months prior to screening, according

to the Investigator's judgment such as, but not limited to cerebral or

gastrointestinal bleeding.

- Lymphocyte count below the lower limit of normal at screening.

- Recent live (attenuated) vaccine within 2 months before the first treatment visit.

- Recent major surgery (within 4 weeks of screening) or planned major surgery during the

study.

- The participant has received medications/treatments for MS within a specified time

frame.

- Receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8

hepatic enzymes.

- Receiving anticoagulant or antiplatelet therapy (such as aspirin, clopidogrel,

warfarin).

- Contraindications to magnetic resonance imaging (MRI).

The above information is not intended to contain all considerations relevant to a patient's

potential participation in a clinical trial.

Studien-Rationale

Primary outcome:

1. 6-month confirmed disability progression (CDP) (Time Frame - Up to 48 approximately months):
Time to onset of 6 months CDP defined as follows: -Increase of ≥1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is ≤5.0, or -Increase of ≥0.5 point when the baseline EDSS score is >5.0 -



Secondary outcome:

1. 3-months change in T25-FW and 9-HPT (Time Frame - Up to approximately 48 months):
Time to onset of composite CDP, confirmed over at least 3 months (3-month CCDP), by the EDSS Plus composite (EDSS score increase, or 20% increase in the T25 FW test, or 20% increase in the 9 hole peg test (9 HPT)

2. 3-month CDP (Time Frame - Up to approximately48 months):
Time to onset of 3-month CDP as assessed by EDSS score

3. New and enlarging T2 hyperintense lesions by MRI (Time Frame - From Baseline up to approximately 48 months):
Total number of new or enlarging T2 hyperintense lesions as detected by MRI

4. Time to onset of confirmed disability improvement (CDI) (Time Frame - From Baseline up to approximately 48 months):
Time to CDI defined as ≥1.0 point decrease on the EDSS score from baseline confirmed over at least 6 months

5. Brain volume loss (BVL) (Time Frame - From 6 Months up to approximately 48 months):
Percent change in Brain volume loss (BVL) as detected by brain MRI at the EOS compared to month 6

6. Change in cognitive function (Time Frame - From Baseline up to approximately 48 months):
Change in cognitive function at the EOS compared to baseline as assessed by the Symbol Digit Modalities Test (SDMT) and by the California Verbal Learning Test (CVLT-II) -

7. Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) (Time Frame - From Baseline up to approximately 48 months):
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) from the baseline through the EOS

8. Safety and Tolerability (Time Frame - From Screening until end of study up to approximately 48 months):
Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)

9. Population pharmacokinetics (Time Frame - Months 6, 9 and 12):
Plasma concentration of SAR442168 and relevant metabolites (population PK assessment) at Months 6, 9, and 12

10. Change in plasma neurofilament light chain (NfL) (Time Frame - From Baseline up to approximately 48 months):
Change in NfL levels at the EOS compared to baseline -

11. Changes in serum Immunoglobulin level (Time Frame - From Baseline up to approximately 48 months):
Changes in serum Immunoglobulin level at the EOS compared to baseline

12. Change in lymphocyte phenotype subsets (Time Frame - From Baseline up to approximately 48 months):
Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline

13. Change in serum chitinase-3 like protein 1 (Chi3L1) (Time Frame - From Baseline up to approximately 48 months):
Change in serum chitinase-3 like protein 1 (Chi3L1) at the EOS compared to baseline

Studien-Arme

  • Experimental: SAR442168
    Dose 1 of oral SAR442168 once daily
  • Placebo Comparator: Placebo
    Placebo tablet to match SAR442168 once daily

Geprüfte Regime

  • Tolebrutinib (SAR442168):
    Pharmaceutical form: Film-coated tablet Route of administration: Oral
  • Placebo to match Tolebrutinib:
    Pharmaceutical form: Film-coated tablet Route of administration: Oral

Quelle: ClinicalTrials.gov


Das könnte Sie auch interessieren
EHA 2021
  • SCD: Häufigere und längere VOC-bedingte Krankenhausaufenthalte nach Vorgeschichte von VOC-Hospitalisierungen – Ergebnisse einer Beobachtungsstudie
  • Real-World-Daten des ERNEST-Registers untermauern Überlebensvorteil unter Ruxolitinib bei primärer und sekundärer Myelofibrose
  • I-WISh-Studie: Ärzte sehen TPO-RAs als beste Option, um anhaltende Remissionen bei ITP-Patienten zu erzielen
  • Phase-III-Studie REACH2 bei steroidrefraktärer akuter GvHD: Hohes Ansprechen auf Ruxolitinib auch nach Crossover
  • SCD: Neues digitales Schmerztagebuch zur tagesaktuellen Erfassung von VOCs wird in Beobachtungsstudie geprüft
  • Französische Real-World-Studie: Eltrombopag meist frühzeitig nach ITP-Diagnose im Rahmen eines Off-label-Use eingesetzt
  • Fortgeschrittene systemische Mastozytose: Französische Real-World-Studie bestätigt klinische Studiendaten zur Wirksamkeit von Midostaurin
  • CML-Management weitgehend leitliniengerecht, aber verbesserungsfähig – Ergebnisse einer Querschnittsbefragung bei britischen Hämatologen
  • Britische Real-World-Studie: Kardiovaskuläres Risikomanagement bei MPN-Patienten in der Primärversorgung nicht optimal
  • Myelofibrose: Früher Einsatz von Ruxolitinib unabhängig vom Ausmaß der Knochenmarkfibrose