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

NCT01051349 | Completed Phase 2 Results DMC

• 2 other identifiers: 205-MS-2032009-015318-23
• Study Type: interventional
• Target: 410
• Locations: 8 countries
• Sites: 65

Brief 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). 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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

MS; Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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.

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

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

  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)

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

  From Baseline through 288 weeks

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

  From Baseline through 288 weeks

• Number of Participants With Total Number of New Gadolinium-enhancing Lesions

  From Baseline through 288 weeks

• Annual Change in Number of T1 Hypointense Lesions

  From Baseline through 288 weeks

• Annual Change in Volume of New Gadolinium-Enhancing Lesions

  From Baseline through 288 weeks

Study Arms (1)

BIIB019

EXPERIMENTAL

Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288.

Biological: BIIB019 (Daclizumab); Biological: trivalent seasonal influenza vaccine

Interventions

BIIB019 (Daclizumab) BIOLOGICAL

Administered as specified in the treatment arm.

Also known as: Daclizumab High Yield Process, DAC HYP

BIIB019

trivalent seasonal influenza vaccine BIOLOGICAL

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

BIIB019

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Biogen: lead
• AbbVie: collaborator

Study Sites (65)

Research Site

Brno, 625 00, Czechia

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Brno, 656 91, Czechia

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Hradec Králové, 500 02, Czechia

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Prague, 100 34, Czechia

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Teplice, 415 29, Czechia

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Bayreuth, 95445, Germany

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Erlangen, 91054, Germany

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Marburg, 35043, Germany

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Rostock, 18147, Germany

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Budapest, 1076, Hungary

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Budapest, 1083, Hungary

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Budapest, 1115, Hungary

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Budapest, 1125, Hungary

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Budapest, 1134, Hungary

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Debrecen, 4032, Hungary

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Esztergom, 2500, Hungary

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Győr, 9024, Hungary

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Kecskemét, 6000, Hungary

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Miskolc, 3526, Hungary

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Miskolc, 3533, Hungary

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Nyíregyháza, 4400, Hungary

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Siófok, 8600, Hungary

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Bangalore, 560034, India

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Hyderabad, 500082, India

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Kolkata, 700068, India

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Mumbai, 400012, India

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Rajasthan, 302021, India

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Bialystok, 15-276, Poland

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Bialystok, 15-420, Poland

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Gdansk, 80-803, Poland

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Katowice, 40-749, Poland

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Katowice, 40-752, Poland

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Krakow, 31-505, Poland

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Lodz, 93-121, Poland

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Lublin, 20954, Poland

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Warsaw, 02-097, Poland

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Warsaw, 02-957, Poland

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Kazan', 420021, Russia

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Krasnoyarsk, 660049, Russia

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Moscow, 107150, Russia

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Moscow, 115682, Russia

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Moscow, 6127018, Russia

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Nizhny Novgorod, 603076, Russia

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Novosibirsk, 630087, Russia

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Omsk, 644033, Russia

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Saint Petersburg, 194291, Russia

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Samara, 443095, Russia

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Smolensk, 214018, Russia

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Ufa, 450005, Russia

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Yaroskavi, 150030, Russia

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Chernivtsi, 58018, Ukraine

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Dnipropetrovsk, 49027, Ukraine

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Donetsk, 83003, Ukraine

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Kharkiv, 61068, Ukraine

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Kiev, 03110, Ukraine

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Kiev, 2125, Ukraine

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Kyiv, 03110, Ukraine

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Poltava, 36024, Ukraine

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Zaporizhia, 69035, Ukraine

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Zaporizhia, 69600, Ukraine

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London, SE59RF, United Kingdom

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Nottingham, NG72UH, United Kingdom

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Plymouth, PL68DH, United Kingdom

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Sheffield, S102JF, United Kingdom

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Stoke-on-Trent, ST47LN, United Kingdom

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Related Publications (3)

• 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.

  PMID: 32451615 DERIVED

• 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.

  PMID: 27461166 DERIVED

• 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.

  PMID: 27411694 DERIVED

Related Links

• The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS their families and healthcare providers

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Daclizumab; daclizumab HYP

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Biogen Study Medical Director
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 18, 2010
• Study Start: March 31, 2010
• Primary Completion: August 25, 2016
• Study Completion: August 25, 2016
• Last Updated: November 9, 2018
• Results First Posted: November 9, 2018

Record last verified: 2018-04

Locations

GB (5); UA (10); HU (13); IN (5); CZ (5); RU (13); DE (4); PL (10)