M340 Progressive systemic sclerosis Progressive systemic sclerosis
Conditions
Interventions
None listed
Sponsors
F. HOFFMANN-LA ROCHE LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed Informed Consent Form • Age 18-65 years inclusive at time of signing Informed Consent Form • Ability to comply with the study protocol • A diagnosis of PPMS in accordance to the revised 2017 McDonald Criteria EDSS score from 3.0 to 6.5 inclusive at screening • For patients currently receiving proton pump inhibitors (PPIs) or H2-receptor antagonists (H2RAs • Patients must not initiate PPIs or H2RAs within 2 weeks of randomization. • For patients requiring symptomatic treatment for MS (e.g., fampridine, cannabis) and/or physiotherapy. • Patients must not initiate symptomatic treatment for MS or physiotherapy within 4 weeks of randomization. • Neurologically stable for at least 30 days prior to randomization and baseline assessments • Ability to complete the 9-HPT for each hand in < 240 seconds • Ability to perform T25FWT • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception. • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm. See protocol for more detail.
Exclusion criteria
Exclusion criteria: • Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to and during screening or treatment with oral anti-microbials within 2 weeks prior to and during screening • History of confirmed or suspected progressive multifocal leukoencephalopathy • History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. • Immunocompromised state • Known presence of other neurological disorders • Evidence of clinically significant cardiovascular (including arrhythmias or QTc prolongation), psychiatric, pulmonary, renal, hepatic, endocrine (including uncontrolled diabetes, non-gallstone pancreatitis, or chronic pancreatitis), metabolic, or gastrointestinal (GI) disease that, in the investigator’s opinion, would preclude patient participation. • Pregnant or breastfeeding • Positive screening tests for active, latent, or inadequately treated hepatitis B • Positive screening tests for hepatitis C (positive hepatitis C antibodies). • Evidence of active or latent or inadequately treated infection with tuberculosis (TB). See protocol for more detail.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of cCDP12, defined as the time from baseline to the first occurrence of a progression event according to at least one of the following three criteria and must be confirmed at a regularly scheduled visit that is at least 12 weeks after the initial disability progression: – An increase from baseline in EDSS score of = 1.0 point in patients with a baseline EDSS score of = 5.5 points or = 0.5 point in patients with a baseline EDSS score of > 5.5 points (confirmed disability progression [CDP]) – = 20% increase from baseline in time to complete the 9-HPT – = 20% increase from baseline in T25FWT NAME OF THE RESULT: Time to onset of cCDP12. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset of cCDP12, defined as the time from baseline to the first occurrence of a progression event according to at least one of the following three criteria and must be confirmed at a regularly scheduled visit that is at least 12 weeks after the initial disability progression: – An increase from baseline in EDSS score of = 1.0 point in patients with a baseline EDSS score of = 5.5 points or = 0.5 point in patients with a baseline EDSS score of > 5.5 points (confirmed disability progression [CDP]) – = 20% increase from baseline in time to complete the 9-HPT – = 20% increase from baseline in T25FWT NAME OF THE RESULT: Time to onset of cCDP12. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;Time to onset of composite 24-week CDP (cCDP24),according to evaluation of study doctor. NAME OF THE RESULT: Time to onset of composite 24-week CDP (cCDP24) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;Time to onset of 12-week CDP (CDP12), defined as an increase from baseline EDSS score of = 1.0 point in patients with a baseline EDSS score of = 5.5 points or = 0.5 point and in patients with a baseline EDSS score of > 5.5 points NAME OF THE RESULT: Time to onset of 12-week CDP (CDP12). PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study. | — |
Countries
Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, New Zealand, Poland, Portugal, Russian Federation, Ukraine, United Kindgdom, United States
Outcome results
None listed