Multiple SclerosisPhase 1NCT02269930
Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers
A Phase 1 study testing peginterferon beta-1a and Rebif in people with Multiple Sclerosis, run by Biogen at 1 site in United States.
Trial summary
The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- peginterferon beta-1a and Rebif
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have a body mass index of 19 to 30 kg/m2, inclusive, and minimum body weight of 45.0 kg at Screening and Day -1
Who cannot join
- History or positive test result at Screening for human immunodeficiency virus, hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb])
- History of premalignant and malignant disease including solid tumors and hematologic malignancies
- Known allergy to any interferon or any component of BIIB017
- Prior treatment with any investigational drug within the 30 days prior to Day 1, or within 5 half-lives of the drug, whichever is longer
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers
The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif.
The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2 weeks in healthy volunteers.
- Conditions
- Multiple Sclerosis
- Being tested
- peginterferon beta-1a, Rebif
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peginterferon beta-1aDrug
Also called BIIB017, Plegridy
Administered as subcutaneous injection
RebifDrug
Administered as subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Treatment Sequence 1: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41 Treatment Sequence 2: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29 Receives: Drug: peginterferon beta-1a; Drug: Rebif |
| Group 2 | Experimental | Treatment Sequence 1: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29 Treatment Sequence 2: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41 Receives: Drug: peginterferon beta-1a; Drug: Rebif |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative area under the concentration-time curve (AUC), as measured by area under the concentration-time curve from time zero to 336 hours post dose (AUC0-336h)
Measured: 2 weeks
Secondary outcomes (2)
Maximum observed serum concentration (Cmax) of BIIB017 and Rebif
Measured: 2 weeks
Number of participants experiencing Adverse Events (AE) and Serious Adverse Events (SAE)
Measured: Up to 4 weeks following treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269930
- Sponsor's protocol ID
- 105HV105
- Status last verified
- Jan 2015
- First submitted
- 17 Oct 2014
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hu X, Shang S, Nestorov I, Hasan J, Seddighzadeh A, Dawson K, Sperling B, Werneburg B. COMPARE: Pharmacokinetic profiles of subcutaneous peginterferon beta-1a and subcutaneous interferon beta-1a over 2 weeks in healthy subjects. Br J Clin Pharmacol. 2016 Aug;82(2):380-8. doi: 10.1111/bcp.12968. Epub 2016 May 29.
PubMed 27060836
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02269930
- Acronym / sponsor ID
- 105HV105
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif.
The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2 weeks in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: peginterferon beta-1a, Drug: RebifTreatment Sequence 1: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41 Treatment Sequence 2: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29 |
| Group 2 | Experimental | Drug: peginterferon beta-1a, Drug: RebifTreatment Sequence 1: SC doses of Rebif on Days 1, 4, 6, 8, 11, and 13; and a single SC dose of BIIB017 on Day 29 Treatment Sequence 2: Single subcutaneous (SC) dose of BIIB017 on Day 1; and SC doses of Rebif on Days 29, 32, 34, 36, 39, and 41 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Must have a body mass index of 19 to 30 kg/m2, inclusive, and minimum body weight of 45.0 kg at Screening and Day -1
Key exclusion criteria (5 listed)
- History or positive test result at Screening for human immunodeficiency virus, hepatitis C virus antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb])
- History of premalignant and malignant disease including solid tumors and hematologic malignancies
- Known allergy to any interferon or any component of BIIB017
- Prior treatment with any investigational drug within the 30 days prior to Day 1, or within 5 half-lives of the drug, whichever is longer
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peginterferon beta-1aAlso: BIIB017, PlegridyAdministered as subcutaneous injection | Drug | Group 1, Group 2 |
| RebifAdministered as subcutaneous injection | Drug | Group 1, Group 2 |
Primary outcome
Cumulative area under the concentration-time curve (AUC), as measured by area under the concentration-time curve from time zero to 336 hours post dose (AUC0-336h)
Time frame: 2 weeks
2 secondary outcomes
Maximum observed serum concentration (Cmax) of BIIB017 and Rebif
Time frame: 2 weeks
Number of participants experiencing Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: Up to 4 weeks following treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
- Derived from this study: PubMed 27060836Hu X, Shang S, Nestorov I, Hasan J, Seddighzadeh A, Dawson K, Sperling B, Werneburg B. COMPARE: Pharmacokinetic profiles of subcutaneous peginterferon beta-1a and subcutaneous interferon beta-1a over 2 weeks in healthy subjects. Br J Clin Pharmacol. 2016 Aug;82(2):380-8. doi: 10.1111/bcp.12968. Epub 2016 May 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing peginterferon beta-1a and Rebif in people with Multiple Sclerosis, run by Biogen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative area under the concentration-time curve (AUC), as measured by area under the concentration-time curve from time zero to 336 hours post dose (AUC0-336h) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02269930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2015.