Active, not recruiting

Phase III Efficacy, Safety, and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDP

This study is no longer recruiting. Please check back for study results.

WHAT IS THE PURPOSE OF THIS STUDY?

This is a Phase III, prospective, multicenter study with two study parts (epochs) to evaluate the efficacy, safety, and tolerability of HYQVIA/HyQvia (IGI, 10% with recombinant human hyaluronidase (rHuPH20) administered subcutaneously) for maintenance therapy to prevent relapse (Epoch 1) and GAMMAGARD LIQUID/KIOVIG (immunoglobulin G intravenous (IGIV) 10% administered intravenously) for the treatment of CIDP (Epoch 2). This study will enroll adult subjects with a confirmed diagnosis of CIDP and who have remained on a stable dosing regimen (monthly equivalent dose of 0.4 to 2.4 g/kg body weight (BW) with a dosing interval of 2 to 6 weeks) of IGIV therapy for at least 3 months prior to screening. In this double-blind, placebo-controlled phase of the study (Epoch 1), eligible subjects will be randomized in a 1:1 ratio to receive either HYQVIA/HyQvia or 0.25% albumin placebo solution with rHuPH20 every two, three, or four weeks in a double-blind fashion for a period of 6 months or until relapse. Subjects who relapse during Epoch 1 will enter Epoch 2 to receive IGIV treatment for a period of 6 months.

TRIAL AT A GLANCE

Condition

Chronic inflammatory demyelinating polyradiculoneuropathy

Study Intervention

HYQVIA; 0.25% albumin placebo solution with rHuPH20; IGIV

Possibility of Active Treatment

Study Type

Interventional

Phase

Phase 3

IS THIS STUDY RIGHT FOR ME?

AGE

18 & UP

N/A

GENDERS

ACCEPTS HEALTHY VOLUNTEERS

No

ENTRY CRITERIA

Inclusion Criteria: 1. Documented diagnosis of definite or probable Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) (focal atypical CIDP and pure sensory atypical CIDP will be excluded) consistent with European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2010 criteria. 2. Participant has responded to IgG treatment in the past (partial or complete resolution of neurological symptoms and deficits), and must currently be on stable doses of intravenous immunoglobulin G (IGIV) treatment within the dose range equivalent to a cumulative monthly dose of 0.4 to 2.4 g/kg BW (inclusive) administered intravenously for at least 12 weeks prior to screening. The dosing interval of IGIV treatment must be between 2 and 6 weeks (inclusive). Variations in the dosing interval of up to ± 7 days or monthly dose amount of up to ± 20% between participant’s pre-study IgG infusions are within acceptable limits 3. Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) disability score between 0 and 7 (inclusive). Participants with INCAT scores of 0, 1, or 2 (if at least 1 point is from an upper extremity) must have a history of significant disability - ie, INCAT disability score of 2 (must be exclusively from the lower extremities) or greater documented in the medical record. 4. If female of childbearing potential, the participant must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the study and for at least 30 days after the last administration of investigational product. 5. Participant is willing and able to sign an Informed Consent Form (ICF). 6. Participant is willing and able to comply with the requirements of the protocol.

Exclusion Criteria: 1. Focal atypical CIDP or pure sensory atypical CIDP. 2. Any neuropathy of other causes, including: a. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth [CMT] disease), multifocal acquired demyelinating sensory and motor neuropathy (MADSAM), and hereditary sensory and autonomic neuropathies (HSANs) b. Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria; systemic lupus erythematosus; polyneuropathy, organomegaly, endocrinopathy or edema, M-protein, skin changes (POEMS) syndrome; osteosclerotic myeloma; diabetic and non-diabetic lumbosacral radiculoplexus neuropathy; lymphoma, and amyloidosis c. Multifocal motor neuropathy (MMN) d. Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy 3. Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titer antibodies to myelin-associated glycoprotein 4. Prominent sphincter disturbance. 5. Central demyelinating disorders (eg, multiple sclerosis). 6. Any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of CIDP or outcome measures (eg, arthritis, stroke, Parkinson’s disease, and diabetic peripheral neuropathy) (Participants with clinically diagnosed diabetes mellitus who do not have diabetic peripheral neuropathy, who have adequate glycemic control with Hemoglobin A1C; also known as glycosylated or glycated hemoglobin (HbA1C) of <7.5% at screening, and who agree to maintain adequate glycemic control during the study are allowed.) 7. Congestive heart failure (New York Heart Association (NYHA) Class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension (ie, diastolic blood pressure >100 mmHg and/or systolic blood pressure >160 mmHg). 8. History of deep vein thrombosis or thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) in the past 12 months. 9. Condition(s) which could alter protein catabolism and/or IgG utilization (eg, protein-losing enteropathies, nephrotic syndrome). 10. Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60 mL/min/1.73m^2 estimated based on CKD-EPI equation (2009). 11. Participant with active malignancy requiring chemotherapy and/or radiotherapy, or history of malignancy with less than 2 years of complete remission prior to screening. Exceptions are: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment. 12. Clinically significant anemia or hemoglobin (Hgb) level of <10.0 g/dL at screening. 13. Hypersensitivity or adverse reactions (eg, urticaria, breathing difficulty, severe hypotension, or anaphylaxis) to human blood products such as human IgG, albumin, or other blood components. 14. Known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin (such as bee or wasp venom). 15. Known history of or immunoglobulin A (IgA) deficiency (<8 mg/dL) at screening. 16. Abnormal laboratory values at screening: a. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x upper limit of normal (ULN) b. Platelet count <100,000 cells/µL c. Absolute neutrophil count (ANC) <1000 cells/µL 17. Ongoing/active infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) Type 1/2 infection. 18. The participant has received or is currently receiving treatment with immunomodulatory/ immunosuppressive agents within 6 months prior to screening. 19. Participant has received or is currently receiving treatment with corticosteroids within 3 months prior to screening. The following exceptions for prednisolone or its equivalent are allowed: stable dosages of low-dose systemic corticosteroids (≤10 mg prednisolone/day or its equivalent) and non-systemic corticosteroids (eg, topical, ophthalmic, or inhaled glucocorticoids). In addition and for the purpose of treating AE or non-CIDP intercurrent disease, a single corticosteroid dose >10 mg prednisolone or a single short term course of ≤ to 7 days (such as Methylprednisolone Dose Pack) within 3 months prior to screening is allowed. 20. Participant has undergone plasma exchange within 3 months prior to screening. 21. The participant has any disorder or condition that in the investigator’s judgment may impede the participant’s participation in the study, pose increased risk to the participant, or confound the results of the study. 22. The participant is nursing or intends to begin nursing during the course of the study. 23. Participation in another clinical study involving an investigational product and/or device within 30 days prior to enrollment, or planned participation in another clinical study during the course of this study. 24. The participant is a family member or employee of the investigator.

Study Locations

    • Argentina
    • Brazil
    • Germany
    • Italy
    • Poland
    • Serbia
    • Turkey
    • United States of America

Enter your city or postal code to find a location near you.

RESULTS

  • 1.

    Recherche Sepmus, Inc.

    Greenfield Park, Quebec
    Canada

    miles

  • 2.

    Montreal Neurological Institute Clinical Research Unit

    Montréal, Quebec
    Canada

    miles

  • 3.

    Fakultni nemocnice Ostrava

    Ostrava - Poruba,
    Czech Republic

    miles

  • 4.

    Vseobecna fakultni nemocnice v Praze

    Praha 2,
    Czech Republic

    miles

  • 5.

    Fakultni nemocnice v Motole

    Praha 5,
    Czech Republic

    miles

  • 6.

    Århus Universitetshospital

    Aarhus,
    Denmark

    miles

  • 7.

    Groupe Hospitalier Pellegrin - Hôpital Pellegrin

    Bordeaux Cedex, Gironde
    France

    miles

  • 8.

    IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia
    Italy

    miles

  • 9.

    Fondazione PTV – Policlinico Tor Vergata

    Pozzilli, Isernia
    Italy

    miles

  • 10.

    Azienda Ospedaliera Universitaria Policlinico G. Martino

    Messina, Messina
    Italy

    miles

  • 11.

    Azienda Ospedaliero Universitaria Pisana

    Pisa, Pisa
    Italy

    miles

  • 12.

    Hospital Universitario Ramon y Cajal

    Madrid, Madrid
    Spain

    miles

  • 13.

    Hospital Universitario La Paz

    Madrid, Madrid
    Spain

    miles

  • 14.

    Hospital Universitari i Politecnic La Fe

    Valencia, Valencia
    Spain

    miles

  • 15.

    Sahlgrenska universitetssjukhuset

    Goteborg,
    Sweden

    miles

  • 16.

    King's College Hospital

    London, Greater London
    United Kingdom

    miles

  • 17.

    The Walton Centre

    Liverpool, Merseyside
    United Kingdom

    miles

  • 18.

    Toronto General Hospital

    Toronto, Ontario
    Canada

    miles

  • 19.

    Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"

    Medellin,
    Colombia

    miles

  • 20.

    Hôpital de la Timone

    Marseille cedex 5, Bouches-du-Rhône
    France

    miles

  • 21.

    Hopital Purpan

    Toulouse cedex 9, Haute Garonne
    France

    miles

  • 22.

    CHU Clermont Ferrand - Hopital Gabriel Montpied

    Clermont Ferrand Cedex, Puy de Dome
    France

    miles

  • 23.

    Universitaetsmedizin Goettingen

    Göttingen, Niedersachsen
    Germany

    miles

  • 24.

    Universitaetsklinikum Essen

    Essen, Nordrhein Westfalen
    Germany

    miles

  • 25.

    Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg

    Marburg, Hessen
    Germany

    miles

  • 26.

    Universitaetsmedizin Rostock

    Rostock, Mecklenburg Vorpommern
    Germany

    miles

  • 27.

    University Hospital of Patra

    Patras,
    Greece

    miles

  • 28.

    Athens Medical Center

    Athens,
    Greece

    miles

  • 29.

    251 General Air Force Hospital

    Athens,
    Greece

    miles

  • 30.

    Chaim Sheba Medical Center

    Ramat Gan,
    Israel

    miles

  • 31.

    Tel Aviv Sourasky Medical Center

    Tel Aviv,
    Israel

    miles

  • 32.

    Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, Torino
    Italy

    miles

  • 33.

    Casa di Cura del Policlinico

    Milano, Milano
    Italy

    miles

  • 34.

    Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

    Udine, Udine
    Italy

    miles

  • 35.

    Oslo Universitetssykehus HF, Ullevål

    Oslo,
    Norway

    miles

  • 36.

    Clinical Center Nis

    Nis,
    Serbia

    miles

  • 37.

    Clinical Center of Serbia

    Belgrade,
    Serbia

    miles

  • 38.

    Fakultna nemocnica Nitra

    Nitra,
    Slovakia

    miles

  • 39.

    Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona
    Spain

    miles

  • 40.

    Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, La Coruña
    Spain

    miles

  • 41.

    Hallands sjukhus

    Halmstad,
    Sweden

    miles

  • 42.

    Universitaetsspital Zuerich

    Zurich,
    Switzerland

    miles

  • 43.

    Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi

    Konya,
    Turkey

    miles

  • 44.

    Pamukkale Uni. Med. Fac.

    Denizli,
    Turkey

    miles

  • 45.

    Bezmialem Vakif

    Istanbul,
    Turkey

    miles

  • 46.

    Uludag University Medical Faculty

    Bursa,
    Turkey

    miles

  • 47.

    Dokuz Eylul University Faculty of Medicine

    Izmir,
    Turkey

    miles

  • 48.

    Marmara University Pendik Research and Training Hospital

    Istanbul,
    Turkey

    miles

  • 49.

    Southmead Hospital

    Bristol, Avon
    United Kingdom

    miles

  • 50.

    CHU de Nice Hôpital Pasteur 2

    Nice Cedex 1, Alpes Maritimes
    France

    miles

  • 51.

    Hopital Neurologique Pierre Wertheimer

    Bron cedex, Rhone
    France

    miles

  • 52.

    Fondazione Istituto Neurologico Casimiro Mondino

    Pavia, Pavia
    Italy

    miles

  • 53.

    Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul,
    Turkey

    miles

  • 54.

    Kepler Universitätsklinikum

    Linz,
    Austria

    miles

  • 55.

    University of Alberta Hospital

    Edmonton, Alberta
    Canada

    miles

  • 56.

    Bezirksklinikum Regensburg

    Regensburg, Bayern
    Germany

    miles

  • 57.

    COPERNICUS Podmiot Leczniczy Sp. z o. o.,

    Gdansk,
    Poland

    miles

  • 58.

    Uniwersyteckie Centrum Kliniczne

    Gdansk,
    Poland

    miles

  • 59.

    Military Medical Academy

    Belgrade,
    Serbia

    miles

  • 60.

    Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona
    Spain

    miles

  • 61.

    Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona
    Spain

    miles

  • 62.

    Celal Bayar University Medical Faculty

    Manisa,
    Turkey

    miles

  • 63.

    Hospital Italiano

    Ciudad Autonoma Buenos Aires, Buenos Aires
    Argentina

    miles

  • 64.

    Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

    Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires
    Argentina

    miles

  • 65.

    Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires
    Argentina

    miles

  • 66.

    LHSC - University Hospital

    London, Ontario
    Canada

    miles

  • 67.

    Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    Roma, Roma
    Italy

    miles

  • 68.

    Hospital Universitario Virgen del Rocio

    Sevilla, Sevilla
    Spain

    miles

  • 69.

    Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin,
    Poland

    miles

  • 70.

    Instituto de Neurologia de Curitiba - Hospital Ecoville

    Curitiba, Paraná
    Brazil

    miles

  • 71.

    Hopital Gui de Chauliac

    Montpellier cedex 5, Herault
    France

    miles

  • 72.

    Universitaetsklinikum Leipzig AoeR

    Leipzig, Sachsen
    Germany

    miles

  • 73.

    Azienda Ospedaliero Universitaria San Martino

    Genova, Genova
    Italy

    miles

  • 74.

    Hospital das Clínicas FMRP-USP

    Ribeirão Preto, Sao Paulo
    Brazil

    miles

  • 75.

    Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

    Mexico, Distrito Federal
    Mexico

    miles

  • 76.

    Neurology Center of Las Vegas

    Las Vegas, Nevada
    United States of America

    miles

  • 77.

    Arizona Neuromuscular Research Center

    Phoenix, Arizona
    United States of America

    miles

  • 78.

    University of South Florida

    Tampa, Florida
    United States of America

    miles

  • 79.

    Barrow Neurological Institute

    Phoenix, Arizona
    United States of America

    miles

  • 80.

    Regents of the University of colorado

    Aurora, Colorado
    United States of America

    miles

  • 81.

    Hospital for Special Surgery

    New York, New York
    United States of America

    miles

  • 82.

    Complejo Medico de la Policia Federal Argentina Churruca Visca

    Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires
    Argentina

    miles

  • 83.

    HUAP - UFF - Hospital Universitario Antonio Pedro - Universidade Federal Fluminense

    Niterói, Rio do Janeiro
    Brazil

    miles

  • 84.

    Hospital das Clínicas da Faculdade de Medicina da UNICAMP

    Campinas, Sao Paulo
    Brazil

    miles

  • 85.

    Hospital Sao Paulo

    São Paulo, Sao Paulo
    Brazil

    miles

  • 86.

    Clinical Hospital Centar Zagreb

    Zagreb,
    Croatia

    miles

  • 87.

    Universitaetsklinikum Duesseldorf AoeR

    Duesseldorf, Nordrhein Westfalen
    Germany

    miles

  • 88.

    Charité Universitaetsmedizin Berlin - Campus Charité Mitte

    Berlin, Berlin
    Germany

    miles

  • 89.

    Universitaetsklinikum Halle (Saale)

    Halle (Saale), Sachsen Anhalt
    Germany

    miles

  • 90.

    Austin Neuromuscular Center

    Austin, Texas
    United States of America

    miles

  • 91.

    Immunoe Research Centers

    Centennial, Colorado
    United States of America

    miles

  • 92.

    University of Cincinnati

    Cincinnati, Ohio
    United States of America

    miles

  • 93.

    University Texas Physicians CAR

    Houston, Texas
    United States of America

    miles

  • 94.

    Rutgers New Jersey Medical School

    Newark, New Jersey
    United States of America

    miles

  • 95.

    Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

    Łódź,
    Poland

    miles

  • 96.

    Cleveland Clinic

    Cleveland, Ohio
    United States of America

    miles

  • 97.

    University of California-Irvine

    Orange, California
    United States of America

    miles

  • 98.

    University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas
    United States of America

    miles

  • 99.

    The Methodist Hospital Research Institute

    Houston, Texas
    United States of America

    miles

  • 100.

    William Beaumont Hospital

    Royal Oak, Michigan
    United States of America

    miles

  • 101.

    Vancouver General Hospital

    Vancouver, British Columbia
    Canada

    miles

  • 102.

    Fundacion Oftalmologica de Santander - FOSCAL

    Bucaramanga,
    Colombia

    miles

  • 103.

    Fundación Valle del Lili

    Cali,
    Colombia

    miles

  • 104.

    Clinical Hospital Centre Rijeka

    Rijeka,
    Croatia

    miles

  • 105.

    Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, Roma
    Italy

    miles

  • 106.

    Istituto Clinico Humanitas

    Rozzano, Milano
    Italy

    miles

  • 107.

    Hospital Dr. Angel Leaño

    Zapopan, Jalisco
    Mexico

    miles

  • 108.

    Hospital Central Dr Ignacio Morones Prieto

    San Luis Potosi, San Luis Potos
    Mexico

    miles

  • 109.

    Hospital Universitario Miguel Servet

    Zaragoza, Zaragoza
    Spain

    miles