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

Immunic Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo matching IMU-838; Drug: IMU-838

Study type: Interventional

Funder types: Industry

Identifiers

NCT05054140

P2-IMU-838-PMS

Details and patient eligibility

About

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

Full description

This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU838 in adult patients with PMS. The study will consist of the following periods:

Screening Period: Approximately 28 days Main Treatment Period: Up to 120 weeks (approximately 2 years) Open Label Extension Period: Up to approximately 8 years

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 2 patient groups, including a placebo group

IMU-838

Experimental group

Description:

IMU-838 as tablet; Administration: Oral - daily

Treatment:

Drug: IMU-838

Placebo

Placebo Comparator group

Description:

Matching placebo as tablet; Administration: Oral - daily

Treatment:

Drug: Placebo matching IMU-838