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Relapsing-Remitting Multiple SclerosisPhase 2SELECTEDNCT01051349

Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis

A Phase 2 study testing BIIB019 (Daclizumab) and trivalent seasonal influenza vaccine in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 65 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Relapsing-Remitting Multiple Sclerosis
What is being tested?
BIIB019 (Daclizumab) and trivalent seasonal influenza vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
410 participants
Where
65 sitesin 8 countries
Study dates
31 Mar 2010to 25 Aug 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  • Subjects who have completed 52 weeks in Study 205MS202 (NCT00870740) and were compliant with the 205MS202 protocol in the opinion of the Investigator.
  • Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.

Who cannot join

  • Subjects with any significant change in their medical status from the previous study that would prelude administration of Daclizumab High Yield Process (DAC HYP) as determined by the Investigator including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in the 205MS201 (NCT00390221) or 205MS202 (NCT00870740) studies. The Investigator must re-review the subject's medical fitness for participation and must consider any diseases that would preclude treatment.
  • Any subject who has permanently discontinued study treatment in Study 205MS202 (NCT00870740) due to an adverse event.
  • Current enrollment in any investigational drug study other than Study 205MS202 (NCT00870740).
  • Ongoing treatment with any approved or experimental disease-modifying treatment for multiple sclerosis.
  • For subjects currently taking valproic acid, carbamazepine, lamotrigine, or phenytoin:
  • Subjects treated with any of these agents for fewer than 6 months prior to study entry are excluded from study participation unless they discontinue the agent(s) prior to study entry.
Show all 10Show fewer
  • Subjects treated with 2 or more of these agents for more than 6 months prior to study entry are excluded from study participation unless they reduce to ≤1 agent prior to study entry.
  • Subjects who have had dose escalations of one of these agents within the 6 months prior to study entry are excluded from study participation unless they revert to a previous dose that had been used for at least 6 months prior to study entry or unless they discontinue the agent prior to study entry
  • Subjects who are currently receiving treatment with isoniazid, propylthiouracil, or nimesulide at the time of study entry and are not able to discontinue the agent or change to an alternative medication allowed by the protocol.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

65 sites in 8 countries.

65 sites in 8 countries

Hungary13 sites

  • Research Site

    Budapest, 1076

  • Research Site

    Budapest, 1083

  • Research Site

    Budapest, 1115

  • Research Site

    Budapest, 1125

  • Research Site

    Budapest, 1134

  • Research Site

    Debrecen, 4032

  • Research Site

    Esztergom, 2500

  • Research Site

    Győr, 9024

  • Research Site

    Kecskemét, 6000

  • Research Site

    Miskolc, 3526

  • Research Site

    Miskolc, 3533

  • Research Site

    Nyíregyháza, 4400

  • Research Site

    Siófok, 8600

Other trials in Hungary

Russia13 sites

  • Research Site

    Kazan', 420021

  • Research Site

    Krasnoyarsk, 660049

  • Research Site

    Moscow, 107150

  • Research Site

    Moscow, 115682

  • Research Site

    Moscow, 6127018

  • Research Site

    Nizhny Novgorod, 603076

  • Research Site

    Novosibirsk, 630087

  • Research Site

    Omsk, 644033

  • Research Site

    Saint Petersburg, 194291

  • Research Site

    Samara, 443095

  • Research Site

    Smolensk, 214018

  • Research Site

    Ufa, 450005

  • Research Site

    Yaroskavi, 150030

Other trials in Russia

Poland10 sites

  • Research Site

    Bialystok, 15-276

  • Research Site

    Bialystok, 15-420

  • Research Site

    Gdansk, 80-803

  • Research Site

    Katowice, 40-749

  • Research Site

    Katowice, 40-752

  • Research Site

    Krakow, 31-505

  • Research Site

    Lodz, 93-121

  • Research Site

    Lublin, 20954

  • Research Site

    Warsaw, 02-097

  • Research Site

    Warsaw, 02-957

Other trials in Poland

Ukraine10 sites

  • Research Site

    Chernivtsi, 58018

  • Research Site

    Dnipropetrovsk, 49027

  • Research Site

    Donetsk, 83003

  • Research Site

    Kharkiv, 61068

  • Research Site

    Kiev, 03110

  • Research Site

    Kiev, 2125

  • Research Site

    Kyiv, 03110

  • Research Site

    Poltava, 36024

  • Research Site

    Zaporizhia, 69035

  • Research Site

    Zaporizhia, 69600

Other trials in Ukraine

Czechia5 sites

  • Research Site

    Brno, 625 00

  • Research Site

    Brno, 656 91

  • Research Site

    Hradec Králové, 500 02

  • Research Site

    Prague, 100 34

  • Research Site

    Teplice, 415 29

Other trials in Czechia

India5 sites

  • Research Site

    Bangalore, 560034

  • Research Site

    Hyderabad, 500082

  • Research Site

    Kolkata, 700068

  • Research Site

    Mumbai, 400012

  • Research Site

    Rajasthan, 302021

Other trials in India

United Kingdom5 sites

  • Research Site

    London, SE59RF

  • Research Site

    Nottingham, NG72UH

  • Research Site

    Plymouth, PL68DH

  • Research Site

    Sheffield, S102JF

  • Research Site

    Stoke-on-Trent, ST47LN

Other trials in United Kingdom

Germany4 sites

  • Research Site

    Bayreuth, 95445

  • Research Site

    Erlangen, 91054

  • Research Site

    Marburg, 35043

  • Research Site

    Rostock, 18147

Other trials in Germany

About this study

Official title: A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)

Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS) relapse, slowing disability progression, and reducing new MS lesion formation in this study population.

Read the detailed description

This study will provide participants who complete Study 205MS202 (NCT00870740) with the option to receive continued open-label Daclizumab High Yield Process (DAC HYP) monotherapy and to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Approximately 60 to 100 participants will be enrolled into an optional open-label, 16-week autoinjector substudy at a selected subset of sites which will run concurrently during the main study, and will evaluate the systemic exposure and local tolerability of subcutaneous administration of DAC HYP by autoinjector. The 2013-2014 trivalent influenza vaccine will be offered to all eligible participants as an optional substudy to assess the effect of DAC-HYP treatment on the immune response to vaccination,

Being tested
BIIB019 (Daclizumab), trivalent seasonal influenza vaccine
Keywords
MS, Multiple Sclerosis
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIIB019 (Daclizumab)Biological

    Also called Daclizumab High Yield Process, DAC HYP

    Administered as specified in the treatment arm.

  • trivalent seasonal influenza vaccineBiological

    All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site

Study groups in NCT01051349
Study groupRoleWhat they receive
BIIB019ExperimentalParticipants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288.
Receives: Biological: BIIB019 (Daclizumab); Biological: trivalent seasonal influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs

    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

    Measured: Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)

  2. Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab

    Measured: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose

Secondary outcomes (16)

  1. Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline

    New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader.

    Measured: From Baseline through 288 weeks

  2. Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline

    New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader.

    Measured: From Baseline through 288 weeks

  3. Number of Participants With Total Number of New Gadolinium-enhancing Lesions

    New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader.

    Measured: From Baseline through 288 weeks

  4. Annual Change in Number of T1 Hypointense Lesions

    Measured: From Baseline through 288 weeks

  5. Annual Change in Volume of New Gadolinium-Enhancing Lesions

    Measured: From Baseline through 288 weeks

  6. Annual Change in Volume of T1 Hypointense Lesions

    Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader.

    Measured: From Baseline through 288 weeks

  7. Percent Change in Total Brain Volume

    To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader.

    Measured: From Baseline through 288 weeks

  8. Number of Participants With Antibodies to DAC HYP

    Measured: Up to Week 288

  9. Annualized Relapse Rate (ARR)

    Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365. Adjusted ARR was reported.

    Measured: Week 288

  10. Number of Participants With Sustained Disability Progression for 12 Weeks

    Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.

    Measured: Week 48 up to Week 288

  11. Number of Participants With Sustained Disability Progression for 24 Weeks

    Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.

    Measured: Week 48 up to Week 288

  12. Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab

    Measured: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose

  13. Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4

    Measured: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose

  14. Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4

    Measured: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose

  15. Participant-Reported Pain Visual Analog Scale (VAS) Score

    The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end ("0 [no pain]" on the left and "100 [very painful]" on the right). The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain.

    Measured: First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose

  16. Summary of Injection Site Assessment Performed by Clinician

    Injection site assessment was performed by clinician and are defined as erythema (redness) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; pigmentation changes (skin discoloration other than redness) rated on a 3 point scale from 0-2, where 0=none, 1=hypopigmentation and 2=hyperpigmentation; induration (swelling) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; tenderness to pressure rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; and local temperature changes of injection sites rated on a 3 point scale where 0=normal, 1=warm and 1=hot. Only those score categories for which there was at least 1 participant are reported.

    Here, Injection=Inj, post-dose=PD

    Measured: First injection (Day 1) and fourth injection (Day 90) 30 minutes; 8, 24, 72, and 120 hours; and 7, 10, and 14 days post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2010 (estimated)
  2. Study start31 Mar 2010
  3. Primary completion25 Aug 2016
  4. Study completion25 Aug 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01051349
Sponsor's protocol ID
205-MS-203
Other IDs
2009-015318-23, 2009
Acronym
SELECTED
Status last verified
Apr 2018
First submitted
15 Jan 2010
Last updated
9 Nov 2018
Data monitoring committee
Yes

Publications

  • Gold R, Radue EW, Giovannoni G, Selmaj K, Havrdova EK, Montalban X, Stefoski D, Sprenger T, Robinson RR, Fam S, Smith J, Chalkias S, Giannattasio G, Lima G, Castro-Borrero W. Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study. J Neurol. 2020 Oct;267(10):2851-2864. doi: 10.1007/s00415-020-09835-y. Epub 2020 May 25.

    PubMed 32451615

  • Gold R, Radue EW, Giovannoni G, Selmaj K, Havrdova E, Stefoski D, Sprenger T, Montalban X, Cohan S, Umans K, Greenberg SJ, Ozen G, Elkins J. Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study. BMC Neurol. 2016 Jul 26;16:117. doi: 10.1186/s12883-016-0635-y.

    PubMed 27461166

  • Gold R, Stefoski D, Selmaj K, Havrdova E, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Neurol Ther. 2016 Dec;5(2):169-182. doi: 10.1007/s40120-016-0048-2. Epub 2016 Jul 13.

    PubMed 27411694

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIIB019 (Daclizumab) and trivalent seasonal influenza vaccine in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 65 sites in 8 countries.

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 3 inclusion and 10 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 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in Hungary, Russia, Poland, Ukraine, Czechia and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs (time frame: Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)). The study lists 2 primary outcomes in all. 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 NCT01051349, which also lists 3 linked publications.

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 9 Nov 2018.

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