Safety and Efficacy of BAF312 in Dermatomyositis

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-25

Study Completion Date

2016-02-17

Brief Summary

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This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal clinical effect. The study was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of 2 mg daily .

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Detailed Description

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The study was prematurely terminated based on the results of an interim analysis where BAF312 did not demonstrate superior efficacy over placebo and a dose-response relationship was not observed. There were no safety concerns. Approximately 56 participants were planned to be randomized. A total of 17 participants were enrolled and randomized by the time the study was terminated.

Conditions

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Active Dermatomyositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BAF312 0.5mg

During period 1, participants were uptitrated daily from BAF312 0.25 mg to 0.5 mg over a 10 day period. After, participants continued on 0.5 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.

Group Type EXPERIMENTAL

BAF312

Intervention Type DRUG

BAF312 was provided as film-coated tablets in strengths of 0.25, 0,5, 1 and 2 mg for oral administration.

BAF312 2mg

During period 1, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.

Group Type EXPERIMENTAL

BAF312

Intervention Type DRUG

BAF312 was provided as film-coated tablets in strengths of 0.25, 0,5, 1 and 2 mg for oral administration.

BAF312 10 mg

During period 1, participants were uptitrated daily from BAF312 0.25 mg to 10.0 mg over a 10 day period. After, participants continued on 10.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.

Group Type EXPERIMENTAL

BAF312

Intervention Type DRUG

BAF312 was provided as film-coated tablets in strengths of 0.25, 0,5, 1 and 2 mg for oral administration.

Placebo

During period 1, participants received matching placebo daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo to BAF312 as tablets for oral administration.

Interventions

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BAF312

BAF312 was provided as film-coated tablets in strengths of 0.25, 0,5, 1 and 2 mg for oral administration.

Intervention Type DRUG

Placebo

Matching placebo to BAF312 as tablets for oral administration.

Intervention Type DRUG

Other Intervention Names

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Siponimod

Eligibility Criteria

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Inclusion Criteria

Written informed consent must be obtained before any assessment is performed.

* Patients who have been defined as "definite" or "probable" based on the criteria of Bohan and Peter (Bohan and Peter 1975) for dermatomyositis at least 3 months before screening
* Patients must have active disease as defined by muscle weakness
* Patients may be on a stable dose of corticosteroid (up/equal to 20 mg once daily prednisone equivalent)
* Patients currently treated with oral or subcutaneous MTX must have been a stable dose of no more/equal to than 25 mg per week
* Patients currently treated with Azathioprine must have been a stable maintenance dose of no more/equal to 3 mg/kg/day
* Negative cancer screening conducted in the 12 months prior to screening visit

Exclusion Criteria

* Dermatomyositis patients having overlap myositis or any other type of myositis including paraneoplastic myositis, drug-induced myopathy, necrotizing myositis
* Preexisting severe cardiac or pulmonary conditions, malignancy of any organ system or significant eye diseases.
* Uncontrolled diabetes mellitus or diabetes complicated with organ involvement.
* Pregnant or nursing (lactating) women

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No