Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019

NCT01797965 | Terminated Phase 3 Results DMC

• 2 other identifiers: 205MS3032012-003176-39
• Study Type: interventional
• Target: 1,501
• Locations: 26 countries
• Sites: 218

Brief Summary

The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318). Secondary objectives of this study in this study population are as follows: To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401).

Conditions

Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. 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.

  First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years)

Secondary Outcomes (42)

• Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period

  Up to 4.6 years in the 303 study

• ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period

  Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study

• Number of Participants With Relapse in the 205MS303 Treatment Period

  Up to 4.6 years in the 303 study

• Number of Participants With Relapse in the 205MS301-303 Combined Study Period

  Up to 5.6 years combining 303 with the initial Study 301

• Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period

  Up to 4.6 years in Study 303

Study Arms (1)

BIIB019

EXPERIMENTAL

BIIB019 150 mg subcutaneous (SC) every 4 weeks

Drug: BIIB019 (Daclizumab)

Interventions

BIIB019 (Daclizumab) DRUG

Participants will receive open-label treatment with BIIB019 150 mg subcutaneous injection every 4 weeks for up to 5 years.

Also known as: Daclizumab High Yield Process, DAC HYP

BIIB019

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a subject currently participating in Study 205MS301 (NCT01064401), or subject currently participating in Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) who has completed End of Study Visit (Week 96 or later).
• 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:

• Any subject who permanently discontinued study treatment in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS301, Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).
• Any significant change in the subject's medical history that would preclude administration of BIIB019, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).
• The Investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in this Study 205MS303.

Sponsors & Collaborators

• Biogen: lead
• AbbVie: collaborator

Study Sites (222)

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Phoenix, Arizona, 85013, United States

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Phoenix, Arizona, 85050, United States

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Tucson, Arizona, 85704, United States

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Little Rock, Arkansas, 72205, United States

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La Jolla, California, 92037, United States

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Aurora, Colorado, 80045, United States

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Centennial, Colorado, 80112, United States

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Naples, Florida, 34102, United States

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Pompano Beach, Florida, 33060, United States

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Atlanta, Georgia, 30327, United States

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Fort Wayne, Indiana, 46804, United States

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Indianapolis, Indiana, 46202, United States

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Kansas City, Kansas, 66160, United States

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Lexington, Kentucky, 40503, United States

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Wellesley, Massachusetts, 02481, United States

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Worcester, Massachusetts, 01605, United States

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Farmington Hills, Michigan, 48334, United States

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Lebanon, New Hampshire, 03756, United States

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Albuquerque, New Mexico, 87131, United States

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Buffalo, New York, 14203, United States

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Latham, New York, 12110, United States

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New York, New York, 10016, United States

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New York, New York, 10065, United States

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Rochester, New York, 14642, United States

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Charlotte, North Carolina, 28207, United States

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Raleigh, North Carolina, 27607, United States

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Winston-Salem, North Carolina, 27103, United States

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Dayton, Ohio, 45408, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97225, United States

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Allentown, Pennsylvania, 18103, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Cordova, Tennessee, 38018, United States

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Franklin, Tennessee, 37064, United States

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Knoxville, Tennessee, 37922, United States

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Round Rock, Texas, 78681, United States

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Henrico, Virginia, 23226, United States

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Tacoma, Washington, 98405, United States

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Milwaukee, Wisconsin, 53215, United States

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Ciudad Autónoma de Buenos Aires, Buenos Aires, C1015ABR, Argentina

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Ciudad Autónoma de Buenos Aires, Buenos Aires, C1061ABD, Argentina

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Godoy Cruz, Mendoza Province, M5501, Argentina

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Rosario, Santa Fe Province, S2000BZL, Argentina

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Auchenflower, Queensland, 4066, Australia

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Heidelberg, Victoria, 3084, Australia

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Belo Horizonte, Minas Gerais, 30150-221, Brazil

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Recife, Pernambuco, 52010-040, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

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Campinas, São Paulo, 13083-888, Brazil

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Ribeirão Preto, São Paulo, 14049-900, Brazil

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Rio de Janeiro, 20270-004, Brazil

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Rio de Janeiro, 21941-590, Brazil

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Vancouver, British Columbia, V6T 2B5, Canada

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Saint Johns, Newfoundland and Labrador, A1B 3V6, Canada

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London, Ontario, N6A 5A5, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Gatineau, Quebec, J9J 0A5, Canada

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Greenfield Park, Quebec, J4V 2J2, Canada

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Jihlava, Kray Vysocina, 586 33, Czechia

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Ostrava, Moravskoslezský kraj, 708 52, Czechia

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Pardubice, Pardubický kraj, 532 03, Czechia

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Prague, Prague, 100 34, Czechia

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Prague, Prague, 128 08, Czechia

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Olomouc, Severomoravsky Kraj, 775 20, Czechia

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Brno, South Moravian, 625 00, Czechia

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Brno, South Moravian, 656 91, Czechia

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Hradec Králové, 500 03, Czechia

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Prague, 150 06, Czechia

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Teplice, Ústecký kraj, 415 29, Czechia

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Copenhagen, 2100, Denmark

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Glostrup Municipality, 2600, Denmark

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Odense C, 5000, Denmark

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Strasbourg, Bas-Rhin, 67091, France

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Marseille, Bouches-du-Rhône, 13385, France

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Caen, Calvados, 14033, France

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Bordeaux, Gironde, 33076, France

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Toulouse, Haute-Garonne, 31059, France

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Nancy, Meurthe-et-Moselle, 54000, France

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Lille, Nord, 59037, France

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Amiens, 80054, France

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Paris, 75019, France

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Bobigny, Île-de-France Region, 93009, France

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Tbilisi, 0179, Georgia

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Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Bayreuth, Bavaria, 95445, Germany

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Erlangen, Bavaria, 91054, Germany

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München, Bavaria, 81675, Germany

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Marburg, Hesse, 35043, Germany

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Rostock, Mecklenburg-Vorpommern, 18147, Germany

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Dresden, Saxony, 01307, Germany

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Bamberg, 96052, Germany

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Athens, Attica, 11525, Greece

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Thessaloniki, Macedonia, 57010, Greece

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Athens, 115 21, Greece

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Thessaloniki, 546 36, Greece

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Miskolc, Borsod-Abauj Zemplen county, 3533, Hungary

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Kecskemét, Bács-Kiskun county, 6000, Hungary

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Székesfehérvár, Fejér, 8000, Hungary

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Balatonfüred, 8230, Hungary

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Budapest, 1125, Hungary

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Budapest, 1134, Hungary

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Budapest, 1145, Hungary

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Budapest, 1204, Hungary

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Debrecen, 4043, Hungary

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Esztergom, 2500, Hungary

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Győr, 9024, Hungary

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Miskolc, 3526, Hungary

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Nyíregyháza, 4400, Hungary

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Hyderabad, Andhra Pradesh, 500082, India

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Bangalore, Karnataka, 560054, India

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Trivandrum, Kerala, 695011, India

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Mumbai, Maharashtra, 400016, India

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Gūrgaon, 122002, India

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Dublin, DU04, Ireland

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Dublin, DU09, Ireland

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Ashkelon, 78278, Israel

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Haifa, 31096, Israel

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Petah Tikva, 49100, Israel

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Safed, 13100, Israel

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Genoa, Liguria, 16132, Italy

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Milan, Lombardy, 20127, Italy

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Padua, Veneto, 35128, Italy

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Catania, 95123, Italy

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Cefalù, 90015, Italy

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Roma, 00133, Italy

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Roma, 00189, Italy

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Distrito Federal, 03310, Mexico

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Distrito Federal, 06700, Mexico

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Chisinau, MD 2001, Moldova

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Chisinau, MD 2028, Moldova

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Plewiska, Greater Poland Voivodeship, 62-064, Poland

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Poznan, Greater Poland Voivodeship, 60-355, Poland

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Poznan, Greater Poland Voivodeship, 60-631, Poland

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Poznan, Greater Poland Voivodeship, 61-853, Poland

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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-681, Poland

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Krakow, Lesser Poland Voivodeship, 31-505, Poland

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Krakow, Lesser Poland Voivodeship, 31-637, Poland

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Lublin, Lublin Voivodeship, 20-954, Poland

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Lodz, Lódzkie, 90-324, Poland

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Warsaw, Masovian Voivodeship, 00-901, Poland

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Warsaw, Masovian Voivodeship, 02-097, Poland

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Warsaw, Masovian Voivodeship, 02-507, Poland

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Warsaw, Masovian Voivodeship, 02-957, Poland

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Warsaw, Masovian Voivodeship, 04-749, Poland

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Bialystok, Podlaskie Voivodeship, 15-276, Poland

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Bialystok, Podlaskie Voivodeship, 15-402, Poland

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Gdansk, Pomeranian Voivodeship, 80-299, Poland

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Gdansk, Pomeranian Voivodeship, 80-952, Poland

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Katowice, Silesian Voivodeship, 40-595, Poland

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Katowice, Silesian Voivodeship, 40-650, Poland

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Katowice, Silesian Voivodeship, 40-752, Poland

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Olsztyn, Warmian-Masurian Voivodeship, 10-443, Poland

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Szczecin, West Pomeranian Voivodeship, 70-111, Poland

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Szczecin, West Pomeranian Voivodeship, 71-252, Poland

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Gdansk, 80-803, Poland

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Grudziądz, 86-300, Poland

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Katowice, 40-684, Poland

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Katowice, 40-749, Poland

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Olsztyn, 10-561, Poland

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Kielce, Świętokrzyskie Voivodeship, 25-726, Poland

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Cluj-Napoca, Cluj, 400012, Romania

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Târgu Mures, Mureș County, 540136, Romania

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Timișoara, Timiș County, 300736, Romania

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Bucharest, 011461, Romania

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Iași, 700656, Romania

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Yaroslavl, Yaroslavlr, 150030, Russia

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Kazan', 420021, Russia

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Kemerovo, 650066, Russia

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Krasnoyarsk, 660022, Russia

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Moscow, 127018, Russia

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Moscow, 129128, Russia

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Nizhny Novgorod, 603005, Russia

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Nizhny Novgorod, 603155, Russia

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Novosibirsk, 630087, Russia

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Omsk, 644043, Russia

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Perm, 614990, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 197376, Russia

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Samara, 443095, Russia

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Smolensk, 214018, Russia

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Tyumen, 625000, Russia

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Ufa, 450005, Russia

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Belgrade, 11000, Serbia

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Kragujevac, 34000, Serbia

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Niš, 18000, Serbia

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Novi Sad, 21000, Serbia

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Badalona, Barcelona, 08035, Spain

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Córdoba, Córdoba, 14008, Spain

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Madrid, Madrid, Communidad Delaware, 28040, Spain

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Girona, 17007, Spain

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L'Hospitalet de Llobregat, 08907, Spain

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Seville, 41071, Spain

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Malmo, Skåne County, 205 02, Sweden

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Stockholm, Södermanland County, 141 86, Sweden

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Stockholm, Södermanland County, 182 88, Sweden

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Gothenburg, Västra Götaland County, 413 45, Sweden

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Stockholm, 171 76, Sweden

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Basel, Basel-Stadt (de), 4031, Switzerland

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Chernivtsi, Chernivtsi Oblast, 58018, Ukraine

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Dnipropetrovsk, Dnipropetrovsk Oblast, 49027, Ukraine

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Donetsk, Donetsk Oblast, 83003, Ukraine

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Kharkiv, Kharkivs’ka Oblast’, 61068, Ukraine

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Kyiv, Kyïv, 02125, Ukraine

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Kyiv, Kyïv, 03110, Ukraine

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Kyiv, Kyïv, 04060, Ukraine

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Odesa, Odesa Oblast, 65025, Ukraine

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Poltava, Poltava Oblast, 36011, Ukraine

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Vinnytsia, Vinnytsia Oblast, 21005, Ukraine

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Zaporizhzhia, Zaporizhzhia Oblast, 69035, Ukraine

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Zaporizhzhia, Zaporizhzhia Oblast, 69600, Ukraine

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Kharkiv, 61103, Ukraine

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Plymouth, Devon, PL6 8BX, United Kingdom

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Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

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Brighton, BN2 5BE, United Kingdom

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London, E1 2AT, United Kingdom

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London, SE5 9RS, United Kingdom

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London, W6 8RF, United Kingdom

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London, WC1N 3BG, United Kingdom

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Nottingham, NG7 2UH, United Kingdom

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Sheffield, S10 2JF, United Kingdom

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Related Publications (1)

• 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

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 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: February 25, 2013
• Study Start: February 15, 2013
• Primary Completion: September 24, 2018
• Study Completion: September 24, 2018
• Last Updated: December 4, 2019
• Results First Posted: December 4, 2019

Record last verified: 2019-11

Locations

IT (7); ME (2); PL (30); US (39); RO (5); HU (13); SE (5); CH (1); BR (7); GE (1); GB (9); CA (6); MO (2); IN (5); FR (10); DE (9); RU (18); AR (4); ES (6); UA (13); GR (4); IE (2); DK (3); AU (2); CZ (11); IL (4)