Trial · NCT01920477

Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris

NCT01920477, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2019-06-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris. Trials, record NCT01920477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01920477

On this page

Trial

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

Title: Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris
NCT number: NCT01920477
Status: Terminated
Phases: Phase 3
Enrollment: 35 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Pemphigus Vulgaris
Interventions: Ofatumumab, Placebo
First posted: 2013-08-12
Last updated: 2019-06-06
Results first posted: 2019-06-06

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy	Baseline up to approximately 60 weeks	Sustained remission = time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to \<=10 mg/day and maintenance of a dose \<=10 mg/day with no new or nonhealing lesions for \>=8 weeks and maintenance of the status until Week 60.
Primary	Duration of Remission on Minimal Steroid Therapy	Baseline up to approximately 60 weeks	Sum of all periods of absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day up to Week 60 was assessed.
Secondary	Percentage of Subjects Achieving Remission on Minimal Steroid Therapy at Week 60	Week 60	Percentage of subjects who achieved absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day for \> or = 8 weeks at Week 60 was assessed. Time to remission was not estimable.
Secondary	Time to Remission While on Minimal Steroid Therapy by Week 60.	Baseline up to approximately 60 weeks	Time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to \<=10 mg/day and maintained dose at \<=10 mg/day with no new or nonhealing lesions for \>=8 weeks by Week 60 was assessed
Secondary	Percentage of Subjects Achieving Remission While Off Steroid Therapy by Week 60	Baseline up to approximately 60 weeks	Percentage of subjects with initial reduction of all steroids for \>=8 weeks with an absence of new or nonhealing (established) lesions by Week 60 were to be assessed. All subjects remained on prednisone/prednisolone so this endpoint could not be analyzed.Time to remission off steroid therapy also could not be analyzed
Secondary	Number of Days a Subject Maintained Minimal Steroid Therapy by Week 60.	Baseline up to approximately 60 weeks	Number of days a subject maintained minimal steroid therapy (an oral prednisone/prednisolone dose of ≤10 mg/day in the absence of new or nonhealing lesions) by Week 60.
Secondary	Time to Initial Flare/Relapse by Week 60	Baseline up to approximately 60 weeks	Time from randomization to the time of appearance of \>=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed
Secondary	Percentage of Participants With no Flare/Relapse by Week 60	Baseline up to approximately 60 weeks	Percentage of participants achieving absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day and did not subsequently have a appearance of \>=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed
Secondary	Plasma Trough Concentrations of Ofatumumab	4 hours post baseline, Days 1-4,7,14, Weeks 4,8,12,16,20,24,36,48,52,56, up to approximately 60 weeks	Only plasma (trough) concentrations of ofatumumab were presented
Secondary	Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A	Baseline up to approximately 60 weeks	Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy	Baseline up to approximately 60 weeks		participants	NUMBER
PRIMARY	Duration of Remission on Minimal Steroid Therapy	Baseline up to approximately 60 weeks		days	MEAN
SECONDARY	Percentage of Subjects Achieving Remission on Minimal Steroid Therapy at Week 60	Week 60		percentage of participants	NUMBER
SECONDARY	Time to Remission While on Minimal Steroid Therapy by Week 60.	Baseline up to approximately 60 weeks		days	MEDIAN
SECONDARY	Percentage of Subjects Achieving Remission While Off Steroid Therapy by Week 60	Baseline up to approximately 60 weeks	All participants remained on steroid therapy
SECONDARY	Number of Days a Subject Maintained Minimal Steroid Therapy by Week 60.	Baseline up to approximately 60 weeks		days	MEAN
SECONDARY	Time to Initial Flare/Relapse by Week 60	Baseline up to approximately 60 weeks		days	MEDIAN
SECONDARY	Percentage of Participants With no Flare/Relapse by Week 60	Baseline up to approximately 60 weeks	number of participants varied across visits	percentage of participants	NUMBER
SECONDARY	Plasma Trough Concentrations of Ofatumumab	4 hours post baseline, Days 1-4,7,14, Weeks 4,8,12,16,20,24,36,48,52,56, up to approximately 60 weeks	number of participants varied across visits	ng/mL	MEAN
SECONDARY	Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A	Baseline up to approximately 60 weeks	number of participants varied across visits	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group191

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

Outcome	Group	Value	Spread	Units
Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy	Ofatumumab	0		participants
Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy	Placebo	0		participants
Duration of Remission on Minimal Steroid Therapy	Ofatumumab	168.0	Standard Deviation 73.33	days
Duration of Remission on Minimal Steroid Therapy	Placebo	122.0	Standard Deviation NA	days
Percentage of Subjects Achieving Remission on Minimal Steroid Therapy at Week 60	Ofatumumab	17.6		percentage of participants
Percentage of Subjects Achieving Remission on Minimal Steroid Therapy at Week 60	Placebo	5.6		percentage of participants
Time to Remission While on Minimal Steroid Therapy by Week 60.	Ofatumumab	NA	95% Confidence Interval 57.0 to NA	days
Time to Remission While on Minimal Steroid Therapy by Week 60.	Placebo	NA	95% Confidence Interval NA to NA	days
Number of Days a Subject Maintained Minimal Steroid Therapy by Week 60.	Ofatumumab	168	Standard Deviation 73.33	days
Number of Days a Subject Maintained Minimal Steroid Therapy by Week 60.	Placebo	122.0	Standard Deviation NA	days

1 to 10 of 191Source ClinicalTrials.gov

See all 191 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ofatumumab	17
Overall Study	STARTED	Placebo	18
Overall Study	Requiried Individualized Follow-up	Ofatumumab	1
Overall Study	Requiried Individualized Follow-up	Placebo	0
Overall Study	COMPLETED	Ofatumumab	2
Overall Study	COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	Ofatumumab	15
Overall Study	NOT COMPLETED	Placebo	17

Source ClinicalTrials.gov

Adverse events134

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	Anaemia	Blood and lymphatic system disorders	Ofatumumab SC	1	17
other	Anaemia	Blood and lymphatic system disorders	Placebo	0	18
other	Ear pain	Ear and labyrinth disorders	Ofatumumab SC	1	17
other	Ear pain	Ear and labyrinth disorders	Placebo	0	18
other	Conjunctival discolouration	Eye disorders	Ofatumumab SC	1	17
other	Conjunctival discolouration	Eye disorders	Placebo	0	18
other	Eye irritation	Eye disorders	Ofatumumab SC	1	17
other	Eye irritation	Eye disorders	Placebo	0	18
other	Eye swelling	Eye disorders	Ofatumumab SC	1	17
other	Eye swelling	Eye disorders	Placebo	0	18

1 to 10 of 134Source ClinicalTrials.gov

See all 134 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ofatumumab SC	0	17
Total, all-cause mortality	Placebo	0	18
Total, other adverse events	Ofatumumab SC	14	17
Total, other adverse events	Placebo	8	18
Total, serious adverse events	Ofatumumab SC	1	17
Total, serious adverse events	Placebo	1	18

Source ClinicalTrials.gov

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 comparisons3

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

Comparison	Source
Ofatumumab vs Placebo: Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy	Trial comparisons
Ofatumumab SC vs Placebo: deaths from any cause	Trial comparisons
Ofatumumab SC vs Placebo: serious adverse events	Trial comparisons

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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