A study to investigate the long-term safety and tolerability of Tolebrutinib in participants with multiple sclerosis

Kriterien zur Teilnahme
I 01. Participants with RMS, PPMS, or NRSPMS who have completed the Phase IIb study LTS16004 or one of the four key Phase III studies on Tolebrutinib (EFC16033, EFC16034, EFC16645, EFC16035) with the investigational product OR participants in the Phase IIb study LTS16004 or in one of the four key Phase III studies on Tolebrutinib, who have temporarily discontinued the investigational product due to a national emergency and have completed study visits. I 02. All Contraceptive methods used must comply with local regulations regarding contraceptive methods for participants in clinical trials. a) Male participants All male participants with RMS (EFC16033, EFC16034) are eligible to participate in LTS17043 if they agree, prior to unblinding of the Phase III key study and until completion of the washout/accelerated elimination procedure for Teriflunomide (if appropriate according to Section 6 and the local approval of Teriflunomide) to: • Waive sperm donation • Additionally either: - Abstinence regarding heterosexual sexual intercourse as a preferred and usual lifestyle (long-term and continuous abstinence) and agreement to remain abstinent. OR - Agreement to use a contraceptive/barrier method as described below: - Agreement to use a condom for men and to advise the partner to use a highly effective contraceptive method, as a condom may break or leak during sexual intercourse if the woman is of childbearing age and currently not pregnant. Note for male participants with PPMS and NRSPMS (EFC16645 and EFC16035) choosing to enroll in LTS17043, and for all male participants with RMS (LTS16004, EFC16033, and EFC16034) receiving Tolebrutinib in OL in the LTS17043 study. b) Female participants Women are eligible to participate if they are not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a woman of childbearing potential. OR • Is a woman of childbearing potential - For female participants with RMS (EFC16033 and EFC16034): agreement to use a highly effective contraceptive method (with a failure rate of < 1% per year), preferably with low user dependency, as described in Appendix 4 (Section 10.4), prior to unblinding of the Phase III key study and until completion of the washout/accelerated elimination procedure for Teriflunomide. - For female participants with PPMS or NRSPMS (EFC16645, EFC16035) choosing to enroll in LTS17043, and for all female participants with RMS receiving Tolebrutinib in OL in the LTS17043 study: agrees to use an acceptable contraceptive method during the study (at least until after the last dose of the study treatment). All female participants who wish to conceive during or after the study must permanently discontinue the study treatment. I 03. The participant is able to sign a consent form, as described in Appendix 1 of the study protocol, which includes adherence to the requirements and restrictions outlined in the patient information and consent form (Informed Consent Form, ICF) and in this study protocol. In countries where the legal age of majority is > 18 years, a specific consent form must also be signed by the participant's legal representative. (BASEC)

Ausschlusskriterien
E 01. The participant is assessed by the investigator to be at risk for a persistent chronic, active (including fever ≥ 38 °C and clinically unstable) or recurrent systemic infection or such an infection is present. E 02. Current alcohol consumption that at the time of the screening visit corresponds to or exceeds: > 2 drinks per day for men and > 1 drink per day for women (1 drink = approximately 14 grams of alcohol = 350 ml, beer = 140 ml, wine = 40 ml spirits), see Section 5.3.2. E 03. Abnormal ECG during the screening visit, deemed clinically significant by the investigator in the context of this study. (BASEC)