CompletedNCT03560739Updated Oct 8, 2021Results posted

A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients

A Phase 2 interventional study of ofatumumab with PRF and ofatumumab with AI in Multiple Sclerosis, sponsored by Novartis Pharmaceuticals. Completed at 41 sites in 9 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-10-08.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 284
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3 program and the to-be-marketed drug-device combinations

Read the detailed description

Characterization of the pharmacokinetics of ofatumumab administered via the PFS used inclinical trials and the to-be-marketed autoinjector at the clinical dose of 20 mg will be conducted after an initial depletion of CD20 positive B-cells. Comparing the ofatumumab pharmacokinetics between the two drug-device combinations only after the induction period is expected to reduce initial high variability due to target-mediated clearance. This ensures a more stable baseline for PK comparison in a parallel group study design and reflects the clinical situation where systemic concentrations are at steady-state. In order to justify the resulting longterm B-cell depletion, a PK comparability study between the PFS and the AI can only be conducted in MS patients rather than in healthy subjects to balance the risk/benefit and to obtain PK data from the relevant patient population. In order for patients to obtain a clinical benefit from participation in the study, continued treatment with ofatumumab will be offered to all eligible patients through enrollment into the open-label Phase 3 extension study (separate protocol, COMB157G2399).

A secondary objective of the study is to characterize the pharmacokinetics following subcutaneous administration of ofatumumab to either the abdominal region or the thigh which are two injections sites allowed in the Phase 3 study and planned for inclusion in the label. Another secondary objective is assessment of immunogenicity during the 12 weeks duration of the study addressing potential differences in ofatumumab anti-drug antibody formation between the PFS and AI devices as well as between abdomen and thigh injection sites.

This was a randomized, open-label, multi-center, parallel group 12-week study to evaluate the pharmacokinetic bioequivalence of ofatumumab injected by pre-filled syringe (PFS) or autoinjector (AI) devices. The study design included four parallel groups of relapsing multiple sclerosis (RMS) patients. Assessment of the primary and secondary endpoints was based on data collected through the dosing interval between Week 8 and Week 12 where approximate steady-state pharmacokinetics was anticipated.

All patients received open-label ofatumumab 20 mg sc every 4 weeks (after an initial loading regimen of three weekly 20 mg doses in the first 14 days) and were randomized (5:5:1:1) into 4 groups dependent on device and location of injection. Randomization was not blinded. Groups: 1: PFS, abdomen, 2: AI, abdomen 3: PFS, thigh 4: AI, thigh.

The study had 3 Parts. Part 1 was a 30 day screening period. Part 2 was a treatment period which had an induction period of 4 weeks, followed by 4 weeks to ensure steady state was reached and a 4 week pharmacokinetics phase for a total of 12 weeks.

Part 3 was a safety follow-up period for patients who completed the study but did not enter the extension study and patients who prematurely discontinued the study. This period was 9 months for patients who had repleted their B-cells (back to baseline value). For patients who had not repleted their B-cells, 3 month assessments were done until their B-cells were repleted or patients had initiated other disease modifying/immunosuppressive thereapy.

Conditions studied

Multiple Sclerosis

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Keywords

Relapsing Multiple Sclerosis
Relapsing-remitting Multiple Sclerosis
Secondary progressive Multiple Sclerosis
Bioequivalence
Pharmacokinetics
Neurofilament light chain
Pre-filled Syringe
Auto-injector
adult
AI
PFS
OMB157

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 284 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Diagnosis of multiple sclerosis (MS)
Relapsing MS: relapsing-remitting course (RRMS), or Secondary progressive (SPMS) course
EDSS score of 0 to 5.5
Documentation of at least: 1 relapse during the previous year OR 2 relapses during the previous 2 years prior to Screening OR a positive Gd-enhancing MRI scan during the year prior to randomization.
Neurologically stable within 1 month prior to randomization

Exclusion criteria

Exclusion Criteria:

Patients with primary progressive MS or SPMS without disease activity
Disease duration of more than 10 years in patients with EDSS score of 2 or less
Patients with an active chronic disease of the immune system other than MS
Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening
Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 284 participants (actual)

Study arms

Other
OMB 20mg PFS abdomen
ofatumumab 20 mg subcutaneous (sc.) injection with pre-filled syringes (PFS) administrated on abdomen
Combination Product: ofatumumab with PRF
Other
OMB 20mg AI abdomen
ofatumumab 20 mg subcutaneous (sc.) injection with autoinjector (AI) administrated on abdomen
Combination Product: ofatumumab with AI
Other
OMB 20mg PFS thigh
ofatumumab 20 mg subcutaneous (sc.) injection with pre-filled syringes (PFS) administrated on thigh
Combination Product: ofatumumab with PRF
Other
OMB 20mg AI thigh
ofatumumab 20 mg subcutaneous (sc.) injection with autoinjector (AI) administrated on thigh
Combination Product: ofatumumab with AI

Interventions

Combination productofatumumab with PRF
ofatumumab 20 mg subcutanious injection administered with pre-filled syringe (PRF)
Combination productofatumumab with AI
ofatumumab 20 mg subcutaneous injection administered with autoinjector (AI)

What researchers measure

Primary outcomes

Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by AUCtau
Bioequivalence of AUCtau ) will be measured over the time period of Week 8 to Week 12 dosing interval comparing the pre-filled syringe (PFS) and autoinjector (AI) devices both administered to the abdomen. Bioequivalence established if both measures meet the corresponding criterion specified by the reference-scaled average bioequivalence (RSABE) approach
Time frame: Week 8 to Week 12 dosing interval
Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by Cmax
Bioequivalence of Cmax will be measured over the time period of Week 8 to Week 12 dosing interval comparing the pre-filled syringe (PFS) and autoinjector (AI) devices both administered to the abdomen. Bioequivalence established if both measures meet the corresponding criterion specified by the reference-scaled average bioequivalence (RSABE) approach
Time frame: Week 8 to Week 12 dosing interval

Secondary outcomes

Pharmacokinetics of the Study Drug as Measured by AUCtau for PFS and AI Devices When Administered to Abdomen or Thigh
Pharmacokinetics following subcutaneous administration of ofatumumab to either the abdominal region or the thigh as measured by the area under the concentration-time curve over the Week 8 - Week 12 dosing interval (AUCtau)
Time frame: Week 8 to Week 12 dosing interval
Pharmacokinetics of the Study Drug as Measured by Cmax for PFS and AI Devices When Administered to Abdomen or Thigh
Pharmacokinetics following subcutaneous administration of ofatumumab to either the abdominal region or the thigh as measured by the maximum concentration (Cmax)
Time frame: Week 8 to Week 12 dosing interval
Plasma Concentrations of the Study Drug for PFS and AI Devices When Administered to Abdomen or Thigh
Plasma concentrations following subcutaneous administration of ofatumumab via PFS or AI to either the abdominal region or the thigh
Time frame: Days 4, 7, 14, 28, 42, 56, 57, 59, 63, 70, 77, 84
Percentage of Patients With Anti-ofatumumab Antibodies
Anti-drug antibodies (ADA) were assessed to evaluate the immunogenicity potential of ofatumumab. Samples for ADA assessment were taken prior to dosing at the visit. Samples were analyzed as per laboratory's SOPs by a Meso Scale Discovery (MSD) electrochemiluminescense assay. All samples confirmed to be positive for the presence of anti-ofatumumab antibodies were assessed to evaluate their ability to neutralize the ofatumumab biologic effect.
Time frame: Baseline, Week 4, 8, 12 and Overall

Results

Posted Oct 9, 2020

Participant flow

Participant flow — Overall Study
Milestone	OMB 20mg AI Abdomen	OMB 20mg PFS Abdomen	OMB 20mg AI Thigh	OMB 20mg PFS Thigh
Started	128	130	13	13
Completed	128	129	13	13
Not completed	0	1	0	0
Withdrew: Adverse event	0	1	0	0

Outcome measures

PrimaryBioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by AUCtau

Bioequivalence of AUCtau ) will be measured over the time period of Week 8 to Week 12 dosing interval comparing the pre-filled syringe (PFS) and autoinjector (AI) devices both administered to the abdomen. Bioequivalence established if both measures meet the corresponding criterion specified by the reference-scaled average bioequivalence (RSABE) approach

Time frame:: Week 8 to Week 12 dosing interval
Reported as:: Geometric mean · h×µg/mL

Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by AUCtau
h×µg/mL	OMB 20mg AI Abdomen	OMB 20mg PFS Abdomen
Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by AUCtau	487.7 ± 103.5	474.1 ± 79.7

Statistical analysis

OMB 20mg AI Abdomen vs OMB 20mg PFS Abdomen · Geo-mean ratio: 1.03 · 90% CI .8 to 1.25The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.
OMB 20mg AI Abdomen vs OMB 20mg PFS Abdomen · 95% upper bound of the linearized criter: -.3131The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion

PrimaryBioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by Cmax

Bioequivalence of Cmax will be measured over the time period of Week 8 to Week 12 dosing interval comparing the pre-filled syringe (PFS) and autoinjector (AI) devices both administered to the abdomen. Bioequivalence established if both measures meet the corresponding criterion specified by the reference-scaled average bioequivalence (RSABE) approach

Time frame:: Week 8 to Week 12 dosing interval
Reported as:: Geometric mean · µg/mL

Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by Cmax
µg/mL	OMB 20mg AI Abdomen	OMB 20mg PFS Abdomen
Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by Cmax	1.409 ± 89.2	1.409 ± 67.9

Statistical analysis

OMB 20mg AI Abdomen vs OMB 20mg PFS Abdomen · Geo-mean ratio: 1.00 · 90% CI .8 to 1.25The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.
OMB 20mg AI Abdomen vs OMB 20mg PFS Abdomen · 95% upper bound of the linearized criter: -0.2446The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion.

SecondaryPharmacokinetics of the Study Drug as Measured by AUCtau for PFS and AI Devices When Administered to Abdomen or Thigh

Pharmacokinetics following subcutaneous administration of ofatumumab to either the abdominal region or the thigh as measured by the area under the concentration-time curve over the Week 8 - Week 12 dosing interval (AUCtau)

Time frame:: Week 8 to Week 12 dosing interval
Reported as:: Geometric mean · h×µg/mL

Pharmacokinetics of the Study Drug as Measured by AUCtau for PFS and AI Devices When Administered to Abdomen or Thigh
h×µg/mL	OMB 20mg AI Abdomen	OMB 20mg PFS Abdomen	OMB 20mg AI Thigh	OMB 20mg PFS Thigh
Pharmacokinetics of the Study Drug as Measured by AUCtau for PFS and AI Devices When Administered to Abdomen or Thigh	487.7 ± 103.5	474.1 ± 79.7	476.0 ± 73.1	544.1 ± 93.8

SecondaryPharmacokinetics of the Study Drug as Measured by Cmax for PFS and AI Devices When Administered to Abdomen or Thigh

Pharmacokinetics following subcutaneous administration of ofatumumab to either the abdominal region or the thigh as measured by the maximum concentration (Cmax)

Time frame:: Week 8 to Week 12 dosing interval
Reported as:: Geometric mean · µg/mL

Pharmacokinetics of the Study Drug as Measured by Cmax for PFS and AI Devices When Administered to Abdomen or Thigh
µg/mL	OMB 20mg AI Abdomen	OMB 20mg PFS Abdomen	OMB 20mg AI Thigh	OMB 20mg PFS Thigh
Pharmacokinetics of the Study Drug as Measured by Cmax for PFS and AI Devices When Administered to Abdomen or Thigh	1.409 ± 89.2	1.409 ± 67.9	1.563 ± 71.3	1.635 ± 50.7

SecondaryPlasma Concentrations of the Study Drug for PFS and AI Devices When Administered to Abdomen or Thigh

Plasma concentrations following subcutaneous administration of ofatumumab via PFS or AI to either the abdominal region or the thigh

Time frame:: Days 4, 7, 14, 28, 42, 56, 57, 59, 63, 70, 77, 84
Reported as:: Geometric mean · µg/mL

Plasma Concentrations of the Study Drug for PFS and AI Devices When Administered to Abdomen or Thigh
µg/mL	OMB 20mg AI Abdomen	OMB 20mg PFS Abdomen	OMB 20mg AI Thigh	OMB 20mg PFS Thigh
Day 4 n=128,127,13,13	0.43076 ± 147.591319	0.40075 ± 119.330376	0.86747 ± 24.481350	0.55704 ± 105.432315
Day 7 n=128, 130,13,13	0.33544 ± 133.205087	0.30511 ± 119.511321	0.36750 ± 94.007762	0.29662 ± 119.353006
Day 14 n=128, 130,12,11	1.07408 ± 105.566707	0.96359 ± 105.735963	0.89788 ± 125.726458	1.30586 ± 83.153962
Day 28 Week 4 n=127, 130,13,13	0.95571 ± 113.510035	0.95774 ± 117.852822	1.11008 ± 66.780045	1.41434 ± 117.959678
Day 42 Week 6 n=128, 130,13,13	0.97327 ± 125.421064	1.12006 ± 113.137164	1.12006 ± 86.390639	1.18239 ± 133.082660
Day 56 Week 8 n=128, 130,13,13	0.28358 ± 142.760137	0.24644 ± 133.056913	0.23874 ± 98.041287	0.45529 ± 143.614763
Day 57 Week 8 n=127, 127,12,13	0.89424 ± 121.357310	0.80986 ± 107.929658	0.96356 ± 122.222991	1.04905 ± 54.771002
Day 59 Week 8 n=127, 127,13,13	1.24143 ± 103.274314	1.23458 ± 81.737063	1.34837 ± 82.596695	1.52705 ± 52.253239
Day 63 Week 9 n=126, 128,13,13	1.27031 ± 84.610014	1.23163 ± 77.294222	1.28263 ± 67.076249	1.43075 ± 66.345270
Day 70 Week 10 n=128, 127,13,13	0.78732 ± 97.440131	0.74111 ± 82.870974	0.67151 ± 82.769087	0.95821 ± 83.645358
Day 77 Week 11 n=127, 127,13,13	0.40249 ± 109.581877	0.33720 ± 114.373887	0.40173 ± 52.479338	0.54085 ± 97.862609
Early Exit n=0,1,0,0	—	0.1870	—	—
EOS Week 12 n=126, 118,12,13	0.20290 ± 113.812416	0.17862 ± 102.507484	0.17361 ± 63.899086	0.27276 ± 98.256573

SecondaryPercentage of Patients With Anti-ofatumumab Antibodies

Anti-drug antibodies (ADA) were assessed to evaluate the immunogenicity potential of ofatumumab. Samples for ADA assessment were taken prior to dosing at the visit. Samples were analyzed as per laboratory's SOPs by a Meso Scale Discovery (MSD) electrochemiluminescense assay. All samples confirmed to be positive for the presence of anti-ofatumumab antibodies were assessed to evaluate their ability to neutralize the ofatumumab biologic effect.

Time frame:: Baseline, Week 4, 8, 12 and Overall
Reported as:: Number · percentage of participants

Percentage of Patients With Anti-ofatumumab Antibodies
percentage of participants	OMB 20mg AI Abdomen	OMB 20mg PFS Abdomen	OMB 20mg PFS Thigh
Baseline n= 128,130,13,13	0.8	3.1	7.7
Week 4 n= 128,130,13,13	0.8	0.0	0.0
Week 8 n= 124,126,13,13	0.0	0.8	0.0
Week 12 n= 125,121, 12,13	0.8	0.0	0.0
Overall n= 128,130,13,13	0.8	3.8	7.7

Adverse events

Collected over Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of 226 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
OMB 20mg AI (ABD)	0/128 (0%)	2/128 (1.6%)	61/128 (47.7%)
OMB 20mg PFS Abdomen	0/130 (0%)	4/130 (3.1%)	53/130 (40.8%)
OMB 20mg AI (THI)	0/13 (0%)	0/13 (0%)	7/13 (53.8%)
OMB 20mg PFS (THI)	0/13 (0%)	0/13 (0%)	7/13 (53.8%)

Most frequent serious events

Most frequent serious events
Event	OMB 20mg AI (ABD)	OMB 20mg PFS Abdomen	OMB 20mg AI (THI)	OMB 20mg PFS (THI)
Gastrointestinal motility disorderGastrointestinal disorders	1/128	0/130	0/13	0/13
Burns second degreeInjury, poisoning and procedural complications	1/128	0/130	0/13	0/13
VertigoEar and labyrinth disorders	0/128	1/130	0/13	0/13
AppendicitisInfections and infestations	0/128	1/130	0/13	0/13
PneumoniaInfections and infestations	0/128	1/130	0/13	0/13
MenometrorrhagiaReproductive system and breast disorders	0/128	1/130	0/13	0/13

Most frequent other events

Showing 10 of 30

Most frequent other events
Event	OMB 20mg AI (ABD)	OMB 20mg PFS Abdomen	OMB 20mg AI (THI)	OMB 20mg PFS (THI)
Injection related reactionInjury, poisoning and procedural complications	41/128	29/130	5/13	6/13
Injection site reactionGeneral disorders	11/128	17/130	0/13	1/13
HeadacheNervous system disorders	13/128	7/130	0/13	1/13
LeukopeniaBlood and lymphatic system disorders	3/128	0/130	1/13	0/13
LymphopeniaBlood and lymphatic system disorders	1/128	2/130	0/13	1/13
DiarrhoeaGastrointestinal disorders	6/128	4/130	1/13	0/13
NauseaGastrointestinal disorders	1/128	0/130	0/13	1/13
AstheniaGeneral disorders	2/128	1/130	0/13	1/13
FatigueGeneral disorders	3/128	5/130	1/13	0/13
Injection site painGeneral disorders	0/128	0/130	0/13	1/13

Baseline characteristics

Age, Customized
Age, Customized(participants)	OMB 20mg AI Abdomen	OMB 20mg PFS Abdomen	OMB 20mg AI Thigh	OMB 20mg PFS Thigh	Total
18 to 30 years	32	29	5	2	68
31 to 40 years	42	53	3	10	108
41 to 55 years	54	48	5	1	108

Sex: Female, Male
Sex: Female, Male(Participants)	OMB 20mg AI Abdomen	OMB 20mg PFS Abdomen	OMB 20mg AI Thigh	OMB 20mg PFS Thigh	Total
Female	92	90	9	8	199
Male	36	40	4	5	85

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	OMB 20mg AI Abdomen	OMB 20mg PFS Abdomen	OMB 20mg AI Thigh	OMB 20mg PFS Thigh	Total
American Indian or Alaska Native	1	0	0	0	1
Black or African American	2	4	0	0	6
White	125	125	13	12	275
Mixed	0	1	0	1	2

Study locations

41 sites

Novartis Investigative Site
Fullerton, California 92835, United States
Novartis Investigative Site
Aurora, Colorado 80045, United States
Novartis Investigative Site
Basalt, Colorado 81621, United States
Novartis Investigative Site
Boulder, Colorado 80301, United States
Novartis Investigative Site
Miami, Florida 33136, United States
Novartis Investigative Site
Tampa, Florida 33609, United States
Novartis Investigative Site
Tampa, Florida 33612, United States
Novartis Investigative Site
West Palm Beach, Florida 33407, United States
Novartis Investigative Site
Indianapolis, Indiana 46256, United States
Novartis Investigative Site
Ozark, Missouri 65721, United States
Novartis Investigative Site
Knoxville, Tennessee 37922, United States
Novartis Investigative Site
Round Rock, Texas 78681, United States
Novartis Investigative Site
Sherman, Texas 75092, United States
Novartis Investigative Site
Vienna, 1010, Austria
Novartis Investigative Site
Vienna, 1090, Austria
Novartis Investigative Site
Sofia, 1113, Bulgaria
Novartis Investigative Site
Sofia, 1309, Bulgaria
Novartis Investigative Site
Sofia, 1413, Bulgaria
Novartis Investigative Site
Sofia, 1431, Bulgaria
Novartis Investigative Site
Brno, Czech Republic 656 91, Czechia
Novartis Investigative Site
Havirov, Czech Republic 736 01, Czechia
Novartis Investigative Site
Teplice, Czech Republic 415 01, Czechia
Novartis Investigative Site
Hradec Kralove, CZE 500 05, Czechia
Novartis Investigative Site
Pardubice, 532 03, Czechia
Novartis Investigative Site
Tallinn, 10617, Estonia
Novartis Investigative Site
Tartu, 51014, Estonia
Novartis Investigative Site
Riga, LV LV-1005, Latvia
Novartis Investigative Site
Riga, LV 1002, Latvia
Novartis Investigative Site
Riga, LV-1038, Latvia
Novartis Investigative Site
Kaunas, LTU LT 50161, Lithuania
Novartis Investigative Site
Vilnius, LT-08661, Lithuania
Novartis Investigative Site
Kazan, 420021, Russian Federation
Novartis Investigative Site
Krasnoyarsk, 660049, Russian Federation
Novartis Investigative Site
Moscow, 127015, Russian Federation
Novartis Investigative Site
Novosibirsk, 630007, Russian Federation
Novartis Investigative Site
Saint Petersburg, 197022, Russian Federation
Novartis Investigative Site
St Petersburg, 190000, Russian Federation
Novartis Investigative Site
Barcelona, Catalunya 08035, Spain
Novartis Investigative Site
Pozuelo de Alarcon, Madrid 28223, Spain
Novartis Investigative Site
El Palmar, Murcia 30120, Spain
Novartis Investigative Site
Castilleja de la cuesta, Sevilla 41950, Spain

References and documents

Publications

Jones B, Li B, Bagger M, Goodyear A, Ludwig I. Statistical methodology for highly variable compounds: A novel design approach for the ofatumumab Phase 2 bioequivalence study. Pharm Stat. 2022 Nov;21(6):1357-1365. doi: 10.1002/pst.2233. Epub 2022 May 23. PubMed 35604539 ↗
Bar-Or A, Wiendl H, Montalban X, Alvarez E, Davydovskaya M, Delgado SR, Evdoshenko EP, Giedraitiene N, Gross-Paju K, Haldre S, Herrman CE, Izquierdo G, Karelis G, Leutmezer F, Mares M, Meca-Lallana JE, Mickeviciene D, Nicholas J, Robertson DS, Sazonov DV, Sharlin K, Sundaram B, Totolyan N, Vachova M, Valis M, Bagger M, Haring DA, Ludwig I, Willi R, Zalesak M, Su W, Merschhemke M, Fox EJ. Rapid and sustained B-cell depletion with subcutaneous ofatumumab in relapsing multiple sclerosis: APLIOS, a randomized phase-2 study. Mult Scler. 2022 May;28(6):910-924. doi: 10.1177/13524585211044479. Epub 2021 Oct 4. PubMed 34605319 ↗

Study documents

Study protocol · Mar 30, 2018
Statistical analysis plan · May 8, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03560739
Lead sponsor: Novartis Pharmaceuticals
Responsible party: Sponsor
First posted: Jun 18, 2018
Start date: Sep 11, 2018
Primary completion: Aug 26, 2019
Completion: May 5, 2020
Results posted: Oct 9, 2020
Last update: Oct 8, 2021

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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