Adults 18 to 70, any sex, with Pemphigus Vulgaris. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Subjects Who Experienced Sustained Remission on Minimal Steroid TherapyPrimary· 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.
Group
Value
95% CI
Ofatumumab
0
Placebo
0
Duration of Remission on Minimal Steroid TherapyPrimary· 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.
Group
Value
95% CI
Ofatumumab
168.0
± 73.33
Placebo
122.0
± NA
Percentage of Subjects Achieving Remission on Minimal Steroid Therapy at Week 60Secondary· 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.
Group
Value
95% CI
Ofatumumab
17.6
Placebo
5.6
Time to Remission While on Minimal Steroid Therapy by Week 60.Secondary· 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
Group
Value
95% CI
Ofatumumab
NA
57.0 – NA
Placebo
NA
NA – NA
Number of Days a Subject Maintained Minimal Steroid Therapy by Week 60.Secondary· 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.
Group
Value
95% CI
Ofatumumab
168
± 73.33
Placebo
122.0
± NA
Time to Initial Flare/Relapse by Week 60Secondary· 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
Group
Value
95% CI
Ofatumumab
448
NA – NA
Placebo
169.0
86.0 – 284.0
Percentage of Participants With no Flare/Relapse by Week 60Secondary· 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
Week 2 no flare
Group
Value
95% CI
Ofatumumab
100.0
Placebo
94.4
Week 2 no new/nonhealing lesions
Group
Value
95% CI
Ofatumumab
47.1
Placebo
22.2
Week 4 no flare
Group
Value
95% CI
Ofatumumab
88.2
Placebo
83.3
Week 4 no new/nonhealing lesions
Group
Value
95% CI
Ofatumumab
47.1
Placebo
38.9
Week 6 no flare
Group
Value
95% CI
Ofatumumab
70.6
Placebo
77.8
Week 6 no new/nonhealing lesions
Group
Value
95% CI
Ofatumumab
41.2
Placebo
33.3
Week 8 no flare
Group
Value
95% CI
Ofatumumab
64.7
Placebo
72.2
Week 8 no new/nonhealing lesions
Group
Value
95% CI
Ofatumumab
35.3
Placebo
33.3
Plasma Trough Concentrations of OfatumumabSecondary· 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
4 hours post dose SS
Group
Value
95% CI
Ofatumumab
56.60
± NA
Day 1 Steady State (SS)
Group
Value
95% CI
Ofatumumab
1917.50
± NA
Day 2 Steady State (SS)
Group
Value
95% CI
Ofatumumab
2994.20
± NA
Day 3 Steady State (SS)
Group
Value
95% CI
Ofatumumab
3553.80
± NA
Day 4 Steady State (SS)
Group
Value
95% CI
Ofatumumab
3619.20
± NA
Day 7 Steady State (SS)
Group
Value
95% CI
Ofatumumab
3434.90
± NA
Day 14 Steady State (SS)
Group
Value
95% CI
Ofatumumab
2055.30
± NA
Week 4
Group
Value
95% CI
Ofatumumab
311.59
± 278.011
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin ASecondary· Baseline up to approximately 60 weeks
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Baseline
Group
Value
95% CI
Ofatumumab
1
Placebo
0
Week 12
Group
Value
95% CI
Ofatumumab
1
Placebo
0
Week 16
Group
Value
95% CI
Placebo
0
Week 24
Group
Value
95% CI
Ofatumumab
1
Placebo
0
Week 36
Group
Value
95% CI
Ofatumumab
1
Placebo
0
Week 48
Group
Value
95% CI
Ofatumumab
1
Placebo
0
Week 52
Group
Value
95% CI
Ofatumumab
1
Placebo
0
Week 56
Group
Value
95% CI
Ofatumumab
1
Placebo
0
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin GSecondary· Baseline up to approximately 60 weeks
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Baseline
Group
Value
95% CI
Ofatumumab
1
Placebo
2
Week 12
Group
Value
95% CI
Ofatumumab
0
Placebo
1
Week 16
Group
Value
95% CI
Placebo
1
Week 24
Group
Value
95% CI
Ofatumumab
0
Placebo
1
Week 36
Group
Value
95% CI
Ofatumumab
0
Placebo
0
Week 48
Group
Value
95% CI
Ofatumumab
0
Placebo
0
Week 52
Group
Value
95% CI
Ofatumumab
0
Placebo
0
Week 56
Group
Value
95% CI
Ofatumumab
0
Placebo
0
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin MSecondary· Baseline up to approximately 60 weeks
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Baseline
Group
Value
95% CI
Ofatumumab
1
Placebo
1
Week 12
Group
Value
95% CI
Ofatumumab
4
Placebo
1
Week 16
Group
Value
95% CI
Placebo
0
Week 24
Group
Value
95% CI
Ofatumumab
4
Placebo
0
Week 36
Group
Value
95% CI
Ofatumumab
4
Placebo
0
Week 48
Group
Value
95% CI
Ofatumumab
3
Placebo
0
Week 52
Group
Value
95% CI
Ofatumumab
2
Placebo
0
Week 56
Group
Value
95% CI
Ofatumumab
2
Placebo
0
Largest Mean Decrease From Baseline for Immunoglobulin A, G and MSecondary· Baseline up to approximately 60 weeks
Immunoglobulins A, G and M were assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Immunoglobulin A
Group
Value
95% CI
Ofatumumab
-0.185
± 0.1181
Placebo
-0.472
± 0.7116
Immunoglobulin G
Group
Value
95% CI
Ofatumumab
-1.172
± 0.9390
Placebo
-0.955
± 0.6205
Immunoglobulin M
Group
Value
95% CI
Ofatumumab
-0.231
± 0.1152
Placebo
-0.263
± 0.3053
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening autoimmune disorder that is characterized by mucocutaneous blisters. Ofatumumab is a novel monoclonal antibody (mAb) that specifically binds to the human CD20 antigen, which is expressed only in B lymphocytes.
The purpose of this study was to evaluate the efficacy, tolerability, and safety of ofatumumab injection for subcutaneous use (ofatumumab SC) 20 milligrams (mg) administered once in every 4 weeks, (with an additional 20 mg loading dose \[i.e. 40 mg total\] at both Week 0 and Week 4) in subjects with PV. It was anticipated that with sustained B-cell depletion in the presence of ofatumumab SC, and the resultant reduction of pathogenic anti Dsg (desmoglein) autoantibodies in PV, that clinical remission of the disease would result.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06486779 — Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study
· recruiting
NCT06867991 — Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
· Phase 3
· recruiting
NCT06345157 — ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients
· active not recruiting
NCT07353216 — Exploring the Efficacy and Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis (RMS) and Its Impact on Se
· recruiting
NCT05809986 — Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 6 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01920477.