Trial · NCT02029274

Safety and Efficacy of BAF312 in Dermatomyositis

NCT02029274, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2019-01-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of BAF312 in Dermatomyositis. Trials, record NCT02029274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02029274

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of BAF312 in Dermatomyositis
NCT number: NCT02029274
Status: Terminated
Phases: Phase 2
Enrollment: 17 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Active Dermatomyositis
Interventions: BAF312, Placebo
First posted: 2014-01-07
Last updated: 2021-01-05
Other registries' IDs: eudract:2013-001799-39
Results first posted: 2019-01-15

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score	Baseline, 6 months	Each muscles tested was evaluated on a 0 - 10 scale where 0 indicated the weakest muscle score and 10 indicated the strongest muscle score. The total MMT24 score ranged from 0 - 240, where an increasing trend in the values indicates improvement. A positive change from baseline indicates improvement.
Secondary	BAF312 Plasma Concentration	6 months
Secondary	Peripheral Blood Lymphocyte Counts	baseline, 6 months	Absolute lymphocyte counts
Secondary	Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score	baseline, 3 months	Each muscles tested was evaluated on a 0-10 scale where 0 indicated the weakest muscle score and 10 indicated the strongest muscle score. the total MMT24 score ranged from 0-240, where an increasing trend in the values indicates improvement. A positive change from baseline indicates improvement.
Secondary	Change From Baseline in 6 Minutes Walking Distance (6-MWD) Test	baseline, 6 months

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score	Baseline, 6 months	The pharmacodynamic (PD) analysis set, which included all randomized participants, was considered for the analysis. Participants with valid baseline MMT24 score and at least one valid post baseline MMT24 score were included in the analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	BAF312 Plasma Concentration	6 months	Pharmacokinetics (PK) analysis set: The PK analysis set included all patients with available PK data and no protocol deviations with relevant impact on PK data.	ng/ml	MEDIAN
SECONDARY	Peripheral Blood Lymphocyte Counts	baseline, 6 months	Safety analysis set: the safety analysis set included all patients that received any study drug.	10^9 cells/Liter	MEAN
SECONDARY	Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score	baseline, 3 months	PD analysis set	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 6 Minutes Walking Distance (6-MWD) Test	baseline, 6 months	PD analysis set	meters	MEAN

Source ClinicalTrials.gov

Results by group23

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score	BAF312 0.5mg		28.286	Standard Error 8.1539	score on a scale
Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score	BAF312 2mg		12.367	Standard Error 7.0967	score on a scale
Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score	BAF312 10 mg		14.026	Standard Error 8.1541	score on a scale
Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score	Placebo		27.735	Standard Error 8.2175	score on a scale
BAF312 Plasma Concentration	BAF312 0.5mg		5.13	Full Range 3.96 to 6.31	ng/ml
BAF312 Plasma Concentration	BAF312 2mg		25.9	Full Range 11.0 to 45.2	ng/ml
BAF312 Plasma Concentration	BAF312 10 mg		54.5	Full Range 50.9 to 58.0	ng/ml
Peripheral Blood Lymphocyte Counts	BAF312 0.5mg	Baseline	0.898	Standard Deviation 0.3807	10^9 cells/Liter
Peripheral Blood Lymphocyte Counts	BAF312 2mg	Baseline	1.410	Standard Deviation 0.7057	10^9 cells/Liter
Peripheral Blood Lymphocyte Counts	BAF312 10 mg	Baseline	1.255	Standard Deviation 0.6178	10^9 cells/Liter

1 to 10 of 23Source ClinicalTrials.gov

See all 23 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	BAF312 0.5mg	5
Overall Study	STARTED	BAF312 2mg	4
Overall Study	STARTED	BAF312 10 mg	4
Overall Study	STARTED	Placebo	4
Overall Study	Fixed Dose Period 2	BAF312 0.5mg	5
Overall Study	Fixed Dose Period 2	BAF312 2mg	4
Overall Study	Fixed Dose Period 2	BAF312 10 mg	4
Overall Study	Fixed Dose Period 2	Placebo	4
Overall Study	COMPLETED	BAF312 0.5mg	4
Overall Study	COMPLETED	BAF312 2mg	4

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events672

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Palpitations	Cardiac disorders	Period 1 Placebo	0	5
other	Palpitations	Cardiac disorders	Period 1 BAF312 0.5 mg/Day	0	4
other	Palpitations	Cardiac disorders	Period 1 BAF312 2 mg/Day	0	4
other	Palpitations	Cardiac disorders	Period 1 BAF312 10 mg/Day	0	4
other	Palpitations	Cardiac disorders	Period 2 Placebo /BAF312 2 mg/Day	0	5
other	Palpitations	Cardiac disorders	Period 2 BAF312 0.5 mg/Day/BAF312 2 mg/Day	0	4
other	Palpitations	Cardiac disorders	Period 2 BAF312 2 mg/Day/BAF312 2 mg/Day	1	4
other	Palpitations	Cardiac disorders	Period 2 BAF312 10 mg/Day/BAF312 2 mg/Day	0	4
other	Tinnitus	Ear and labyrinth disorders	Period 1 Placebo	0	5
other	Tinnitus	Ear and labyrinth disorders	Period 1 BAF312 0.5 mg/Day	0	4

1 to 10 of 672Source ClinicalTrials.gov

See all 672 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Period 1 Placebo
Total, all-cause mortality	Period 1 BAF312 0.5 mg/Day
Total, all-cause mortality	Period 1 BAF312 2 mg/Day
Total, all-cause mortality	Period 1 BAF312 10 mg/Day
Total, all-cause mortality	Period 2 Placebo /BAF312 2 mg/Day
Total, all-cause mortality	Period 2 BAF312 0.5 mg/Day/BAF312 2 mg/Day
Total, all-cause mortality	Period 2 BAF312 2 mg/Day/BAF312 2 mg/Day
Total, all-cause mortality	Period 2 BAF312 10 mg/Day/BAF312 2 mg/Day
Total, other adverse events	Period 1 Placebo	1	5
Total, other adverse events	Period 1 BAF312 0.5 mg/Day	1	4

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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