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Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis

NCT05054140

UnknownPhase 2

Sponsor: Immunic AG

Conditions: Multiple Sclerosis

Interventions: IMU-838, Placebo matching IMU-838

Countries: United States, Bulgaria, Canada, Czechia, Germany, Moldova, Netherlands, North Macedonia

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Adult patients, age 18 to 65 years (inclusive).
* EDSS score at screening between 3.0 to 6.5 (both inclusive)
* No evidence of relapse in the last 24 months before randomization, AND Patients diagnosed according to 2017 revised McDonald Criteria 1 and the 2013 revised classification of disease courses 2 as either

  1. SPMS inpatients showing evidence of Gd+MRI lesions (active SPMS) or without Gd+MRI lesions (non-active SPMS) in the last 12 months, OR
  2. PPMS
* Willingness and ability to comply with the protocol.
* Written informed consent given by the patient before the beginning of any study-related procedure.
* Documented evidence of disability progression not temporarily related to a relapse in the last 24 months before randomization, adjudicated by a central independent reviewer

Exclusion Criteria:

* Any disease other than MS that may better explain the signs and symptoms, including a history of complete transverse myelitis.
* Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-associated encephalomyelitis (i.e.,presence of anti-NMO \[aquaporin-4\] antibodies or anti-MOG antibodies).
* Previous or current use of MS treatments lifelong, or within a pre-specified time period.
* Use of any investigational product within 8 weeks or 5 the respective PK half- life before the date of informed consent, whichever is longer, and throughout the study.For some investigational products, prolonged biological effects beyond 8 weeks should be considered.
* Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) within14 days before randomization. In case of known SARS-CoV-2 infection, patients should be randomized no earlier than 14 days after 2 consecutive negative tests confirming virus negative status.The screening period can be extended for these patients to accommodate the required virus negativity.
* Positive IFN-gamma release assay (IGRA) for Mycobacterium tuberculosis at SV1.
* Positive hepatitis B virus (HBV) surface antigen, hepatitis B core antibody, positive hepatitis C virus (HCV) antibody, and/or HIV-antigen-antibody test at SV1.
Locations (73)
  • Coral Springs, Florida, United States
  • Naples, Florida, United States
  • Ormond Beach, Florida, United States
  • Atlanta, Georgia, United States
  • Northbrook, Illinois, United States
  • Lutherville, Maryland, United States
  • Detroit, Michigan, United States
  • Albuquerque, New Mexico, United States
  • Blagoevgrad, Bulgaria
  • Burgas, Bulgaria
  • Pleven, Bulgaria
  • Pleven, Bulgaria
  • Plovdiv, Bulgaria
  • Rousse, Bulgaria
  • Shumen, Bulgaria
  • Shumen, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Stara Zagora, Bulgaria
  • Varna, Bulgaria
  • Montreal, Canada
  • Ottawa, Canada
  • Hradec Králové, Czechia
  • + 43 more on CT.gov