A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 2

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: Placebo matched to atacicept; Drug: Atacicept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642902

28063

Details and patient eligibility

About

To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.

Enrollment: 255 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion criteria could apply.

Exclusion criteria

• Have primary progressive multiple sclerosis (MS)
• Have secondary progressive MS without superimposed relapses
• Relevant cardiac, hepatic and renal diseases as specified in the protocol
• Pretreatment with immunosuppressants and immunomodulating drugs as specified in the protocol
• Clinical significant abnormalities in blood cell counts and immunoglobulin levels as specified in the protocol
• Clinical significant acute or chronic infections as specified in the protocol Other protocol-defined exclusion criteria could apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

255 participants in 4 patient groups, including a placebo group

Atacicept 25 mg

Experimental group

Treatment:

Drug: Atacicept

Drug: Atacicept

Drug: Atacicept

Atacicept 75 mg

Experimental group

Treatment:

Drug: Atacicept

Drug: Atacicept

Drug: Atacicept

Atacicept 150 mg

Experimental group

Treatment:

Drug: Atacicept

Drug: Atacicept

Drug: Atacicept

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matched to atacicept