Relapsing-Remitting Multiple SclerosisPhase 2SELECTNCT00390221

Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis

A Phase 2 study testing BIIB019 (Daclizumab High Yield Process) in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 56 sites in 8 countries.

Completed

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

Official record

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Trial summary

The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the… Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Relapsing-Remitting Multiple Sclerosis
What is being tested?: BIIB019 (Daclizumab High Yield Process)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 621 participants
Where: 56 sitesin 8 countries
Study dates: Feb 2008to Aug 2011
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Multiple Sclerosis (MS) subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria:
Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS , OR
Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.

Who cannot join

Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
History of malignancy
History of severe allergic or anaphylactic reactions or known drug hypersensitivity
History of abnormal laboratory results based on investigator judgment
History of human immunodeficiency virus (HIV) or other immunodeficient conditions
History of drug or alcohol abuse within the 2 years prior to randomization

Show all 12Show fewer

An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
Positive screening for active infection with Hepatitis B virus or Hepatitis C virus
Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening
Exposure to varicella zoster virus within 21 days before Screening.
Abnormal blood tests at Screening: Hemoglobin ≤9.0 g/dL, Platelets ≤100 × 10^9/L, Lymphocytes ≤1.0 × 10^9/L, Neutrophils ≤1.5 × 10^9/L, alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase >2 times the upper limit of normal (ULN) and serum creatinine >ULN.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

56 sites in 8 countries.

Country

City, postcode or hospital

56 sites in 8 countries

Russia11 sites

Research Site
Kazan'
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Smolensk
Research Site
Ufa
Research Site
Yaroslavl

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Hungary9 sites

Research Site
Budapest
Research Site
Debrecen
Research Site
Esztergom
Research Site
Győr
Research Site
Kecskemét
Research Site
Miskolc
Research Site
Nyíregyháza
Research Site
Siófok
Research Site
Zalaegerszeg

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Ukraine8 sites

Research Site
Chernivtsi
Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Kharkiv
Research Site
Kiev
Research Site
Lviv
Research Site
Poltava
Research Site
Zaporizhzhya

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India7 sites

Research Site
Andra-Pradeash
Research Site
Bangalore
Research Site
Chennai
Research Site
Kolkata
Research Site
Mumbai
Research Site
Rajasthan
Research Site
Visakhapatnam

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Poland7 sites

Research Site
Bialystok
Research Site
Gdansk
Research Site
Katowice
Research Site
Krakow
Research Site
Lodz
Research Site
Lublin
Research Site
Warsaw

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Germany5 sites

Research Site
Erlangen
Research Site
Marburg
Research Site
Osnabrück
Research Site
Regensburg
Research Site
Rostock

Other trials in Germany

United Kingdom5 sites

Research Site
London
Research Site
Nottingham
Research Site
Plymouth
Research Site
Sheffield
Research Site
Stoke-on-Trent

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Czechia4 sites

Research Site
Brno
Research Site
Olomouc
Research Site
Pilsen
Research Site
Teplice

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About this study

Official title: Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis

Conditions: Relapsing-Remitting Multiple Sclerosis
Being tested: BIIB019 (Daclizumab High Yield Process), Placebo
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 High Yield Process)Biological
Also called DAC HYP, Daclizumab HYP
SC injection
PlaceboDrug
Placebo SC injection

Study groups in NCT00390221
Study group	Role	What they receive
Placebo	Placebo comparator	Participants will receive 3 subcutaneous (SC) injections of placebo every 4 weeks for up to 52 weeks. Receives: Drug: Placebo
150 mg DAC HYP	Experimental	Participants will receive 3 SC injections every 4 weeks for up to 52 weeks. Receives: Biological: BIIB019 (Daclizumab High Yield Process)
300 mg DAC HYP	Experimental	Participants will receive 3 SC injections every 4 weeks for up to 52 weeks. Receives: Biological: BIIB019 (Daclizumab High Yield Process)

What is being measured

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

Adjusted Annualized Relapse Rate Between Baseline and Week 52
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 annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of subject-years followed in the study.
Measured: Baseline through Week 52

Secondary outcomes (4)

Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24
Gd-enhancing lesions are detected when Gd leaks into a perivascular space due to local breakdown of the blood-brain barrier, indicating the presence of active inflammation. For participants with missing data the last valid nonbaseline measurement was carried forward if the participant was missing only 1 or 2 consecutive postbaseline scans. Otherwise the mean based on treatment group and visit was used as the imputed value. Estimated from a negative binomial model adjusted for the baseline number of Gd-enhancing lesions.
Measured: Week 8 through Week 24
Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52
Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss.
Measured: Week 52
Proportion of Participants Who Relapsed at Week 52
Estimated cumulative proportion of participants relapsed at Week 52, based on the Kaplan-Meier product limit method. Only relapses confirmed by the Independent Neurology Evaluation Committee were included in the analysis.
Measured: Week 52
Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52
The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Responses use a 5 point Likert scale range from 1 to 5. All questions are to be answered. The total score is the sum of points for all 29 questions, with a minimum score of 29, and a maximum score of 145. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a subject's functioning.
Measured: Baseline and Week 52

Timeline

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

Feb 2008Aug 2011

First posted19 Oct 2006 (estimated)
Study startFeb 2008
Primary completionMay 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Relapsing-Remitting 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 621 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00390221
Sponsor's protocol ID: 205-MS-201
Acronym: SELECT
Status last verified: May 2016
First submitted: 17 Oct 2006
Last updated: 11 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Huss DJ, Mehta DS, Sharma A, You X, Riester KA, Sheridan JP, Amaravadi LS, Elkins JS, Fontenot JD. In vivo maintenance of human regulatory T cells during CD25 blockade. J Immunol. 2015 Jan 1;194(1):84-92. doi: 10.4049/jimmunol.1402140.
PubMed 25416807
Gold R, Giovannoni G, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, Robinson R, Riester K, Rana J, Elkins J, O'Neill G; SELECT study investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Jun 22;381(9884):2167-75. doi: 10.1016/S0140-6736(12)62190-4. Epub 2013 Apr 4.
PubMed 23562009

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis
ClinicalTrials.gov ID: NCT00390221
Acronym / sponsor ID: SELECT / 205-MS-201
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: MS, multiple sclerosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 621 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Collaborators: AbbVie
Study start: Feb 2008
Primary completion: May 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 19 Oct 2006 (estimated)
Results: Posted 11 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive 3 subcutaneous (SC) injections of placebo every 4 weeks for up to 52 weeks.
150 mg DAC HYP	Experimental	Biological: BIIB019 (Daclizumab High Yield Process)Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.
300 mg DAC HYP	Experimental	Biological: BIIB019 (Daclizumab High Yield Process)Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Multiple Sclerosis (MS) subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria:

Key exclusion criteria (12 listed)

Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
History of malignancy
History of severe allergic or anaphylactic reactions or known drug hypersensitivity
History of abnormal laboratory results based on investigator judgment
History of human immunodeficiency virus (HIV) or other immunodeficient conditions

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
BIIB019 (Daclizumab High Yield Process)Also: DAC HYP, Daclizumab HYPSC injection	Biological	150 mg DAC HYP, 300 mg DAC HYP
PlaceboPlacebo SC injection	Drug	Placebo

Primary outcome

Adjusted Annualized Relapse Rate Between Baseline and Week 52
Time frame: Baseline through Week 52
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 annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of subject-years followed in the study.

4 secondary outcomes

Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24
Time frame: Week 8 through Week 24
Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52
Time frame: Week 52
Proportion of Participants Who Relapsed at Week 52
Time frame: Week 52
Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52
Time frame: Baseline and Week 52

Results and safety

Results posted to the registry on 11 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	204	186
150 mg DAC HYP	208	188
300 mg DAC HYP	209	194

Primary outcome: Adjusted Annualized Relapse Rate Between Baseline and Week 52

Time frame: Baseline through Week 52. Number (95% Confidence Interval). Unit: relapses per person-years

Measure	Placebo n = 196	150 mg DAC HYP n = 201	300 mg DAC HYP n = 203
Value	0.458 (0.370 to 0.566)	0.211 (0.155 to 0.287)	0.230 (0.172 to 0.308)

Placebo vs 150 mg DAC HYP: Rate Ratio: 0.461 (95% CI 0.318 to 0.668), p <0.0001, Negative Binomial Regression
Placebo vs 300 mg DAC HYP: Rate Ratio: 0.503 (95% CI 0.352 to 0.721), p = 0.0002, Negative Binomial Regression

Population analysed: Intent to treat population: all randomized participants who received at least 1 dose of study medication (excluding 21 participants from a single site due to a protocol violation in dosing).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs and SAEs were collected from the Screening Visit (≤ 21 Days prior to Baseline) through the Follow-Up Visit (Week 72 ± 5 days) or early discontinuation.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	53 of 204 (26%)	128 of 204 (62.7%)	Not reported
150 mg DAC HYP	32 of 208 (15.4%)	109 of 208 (52.4%)	Not reported
300 mg DAC HYP	36 of 209 (17.2%)	111 of 209 (53.1%)	Not reported
Total Active	68 of 417 (16.3%)	220 of 417 (52.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25416807Huss DJ, Mehta DS, Sharma A, You X, Riester KA, Sheridan JP, Amaravadi LS, Elkins JS, Fontenot JD. In vivo maintenance of human regulatory T cells during CD25 blockade. J Immunol. 2015 Jan 1;194(1):84-92. doi: 10.4049/jimmunol.1402140.
Derived from this study: PubMed 23562009Gold R, Giovannoni G, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, Robinson R, Riester K, Rana J, Elkins J, O'Neill G; SELECT study investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Jun 22;381(9884):2167-75. doi: 10.1016/S0140-6736(12)62190-4. Epub 2013 Apr 4.
(MSActiveSource.com is a resource for news, information, and disease management for all individuals touched by Multiple Sclerosis. This site is sponsored by Biogen Idec.)Link provided by the sponsor.
(The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.)Link provided by the sponsor.

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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

56 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIIB019 (Daclizumab High Yield Process) in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 56 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 12 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 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Russia, Hungary, Ukraine, India, Poland 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. Some participants in this study may receive a placebo. 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 11 Jul 2016). 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?

Adjusted Annualized Relapse Rate Between Baseline and Week 52 (time frame: Baseline through Week 52). 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 NCT00390221, which also lists 2 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 11 Jul 2016.