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Terminated Phase 2 Interventional Results available

Safety and Efficacy of BAF312 in Dermatomyositis

ClinicalTrials.gov ID: NCT02029274

Public ClinicalTrials.gov record NCT02029274. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 4:45 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double Blind, Randomized, Placebo-controlled Study to Evaluate, Safety, Tolerability, Efficacy and Preliminary Dose-response of BAF312 in Patients With Active Dermatomyositis (DM)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 .

Study identification

NCT ID
NCT02029274
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
17 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 25, 2013 (Actual)
Primary completion
Feb 17, 2016 (Actual)
Completion
Feb 17, 2016 (Actual)
Last update posted
Jan 5, 2021

2013 – 2016

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Novartis Investigative Site Phoenix Arizona 85028 —
Novartis Investigative Site Los Angeles California 90095 —
Novartis Investigative Site Orange California 92868 —
Novartis Investigative Site Miami Florida 33136 —
Novartis Investigative Site Kansas City Kansas 66160 —
Novartis Investigative Site Boston Massachusetts 02115 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02029274, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 5, 2021 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02029274 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →