A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.

• Register: EUCTR
• Last refreshed on: 8 June 2020
• Main ID: EUCTR2017-004702-17-EE
• Date of registration: 28/08/2018
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.
• Scientific title: 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
• Date of first enrolment: 17/09/2018
• Target sample size: 284
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004702-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: Ofatumumab prefilled syringe (PFS); Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Bulgaria, Czech Republic, Estonia, Germany, Italy, Latvia, Lithuania, Poland, Russian Federation, Spain, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

Inclusion criteria:
MS Patients eligible for inclusion in this study must fulfill all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Male or Female patients aged 18 to 55 years (inclusive) at screening.
3. Diagnosis of MS according to the 2010 Revised McDonald criteria
4. Relapsing MS: relapsing-remitting course (RRMS), or secondary progressive (SPMS) course with disease activity
5. Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive)
6. Documentation of at least: 1 relapse during the previous 1 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. Note: Screening MRI scan may be used if no positive Gd enhancing scan exist from prior year.
7. Neurologically stable within 1 month prior to randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 284
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
MS Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Patients suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator
2. Patients with primary progressive MS (Polman et al. 2011) or SPMS without disease activity (Lublin et al. 2014)
3. Patients meeting criteria for neuromyelitis optica (Wingerchuk et al. 2006)
4. Disease duration of more than 10 years in patients with EDSS score of 2 or less
5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 12 months after stopping of study medication. Highly effective contraception methods include:
•Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
•Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
•Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
•Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug.
In case local regulations deviate from the contraception methods listed above, local regulations apply and will be described in the ICF
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
7. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren’s syndrome, Crohn’s disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency)
8. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening
9. Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed P

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: Secondary objectives of the Core part:
1. To characterize the pharmacokinetics following subcutaneous administration of ofatumumab to either the abdominal region or the thigh
2. Assessment of immunogenicity
3. Asses the safety and tolorability of ofatumumab
See protocol for complete list of secondary objectives

Primary end point(s): AUC and Cmax calculated from data collected in the dosing interval after Week 8 dose administration in accordance with the assessment schedule.

Main Objective: Demonstrate pharmacokinetic bioequivalence of 20 mg ofatumumab injected by prefilled syringe (PFS) or autoinjector (AI) devices

Timepoint(s) of evaluation of this end point: At week 8 and 12.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Up to 12 weeks

Secondary end point(s): - AUC
- Cmax
- Proportion of patients with anti-ofatumumab antibodies
- Adverse events including injection related reaction, lab, vital signs, ECG, and eCSSRS

Secondary ID(s)

COMB157G2102

2017-004702-17-AT

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date: 16/08/2018
Contact: