A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
NCT ID: NCT02549170
Last Updated: 2023-05-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
138 participants
INTERVENTIONAL
2015-12-15
2022-02-23
Brief Summary
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* Subcutaneous self-infusion with HyQvia.
* Intravenous infusion with Gammagard/Kiovig. Gammagard and Kiovig are the brand names for the same immunoglobulin compound.
The study is in two parts. In Part 1, participants receive either HyQvia or a placebo subcutaneously. In Part 2 (only for participants who have a CIPD relapse during Part 1), participants will receive Gammagard Liquid/Kiovig intravenously. US participants will receive Gamunex-C.
The first SC infusion will be given in the study clinic. The remaining SC infusions may be given in the study clinic or the participant's home. This will be decided by the study doctor and whether the participant or their caregiver can do the self-infusion.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Epoch 1: HYQVIA/HyQvia
Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, following by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.
HYQVIA
Participants will receive HYQVIA/HyQvia SC which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).
Epoch 1: Placebo with rHuPH20
Participants received rHuPH20 80 U/I0 mL placebo solution, followed by SC placebo infusion at matching infusion volume as the participant's pre-randomization monthly equivalent IG dose when administered every 2, 3, or 4 weeks for 31.54 weeks or until relapse.
0.25% albumin placebo solution with rHuPH20
Participants will receive placebo solution (0.25% human albumin in Lactated Ringer's solution) and rHuPH20.
Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG
Participants who were enrolled to receive placebo with rHuPH20 and achieved chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg bi-weekly (BW), followed by IV infusion at the same monthly equivalent dose as the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.
IGIV GAMMAGARD LIQUID/KIOVIG
Participants will receive GAMMAGARD LIQUID/KIOVIG
Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG
Participants who were enrolled to receive HYQVIA/HyQvia (rHuPH20) and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 28.67 weeks or until relapse.
IGIV GAMMAGARD LIQUID/KIOVIG
Participants will receive GAMMAGARD LIQUID/KIOVIG
Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C
Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
IGIV GAMUNEX®-C
Participants will receive GAMUNEX®-C
Interventions
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HYQVIA
Participants will receive HYQVIA/HyQvia SC which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).
0.25% albumin placebo solution with rHuPH20
Participants will receive placebo solution (0.25% human albumin in Lactated Ringer's solution) and rHuPH20.
IGIV GAMMAGARD LIQUID/KIOVIG
Participants will receive GAMMAGARD LIQUID/KIOVIG
IGIV GAMUNEX®-C
Participants will receive GAMUNEX®-C
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant has a documented diagnosis of definite or probable Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) (focal atypical CIDP and pure sensory atypical CIDP will be excluded), as confirmed by a neurologist specializing/experienced in neuromuscular diseases to be consistent with the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2010 criteria (European Federation of Neurological Societies, 2010). Fulfillment of electrodiagnostic criteria must be confirmed by an independent qualified/experienced central reader.
3. 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 IGIV treatment within the dose range equivalent to a cumulative monthly dose of 0.4 to 2.4 gram per kilogram (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 Immunoglobulin G (IgG) infusions are within acceptable limits.
4. INCAT disability score between 0 and 7 (inclusive). Participants with INCAT scores of 0, 1 (whether from upper or lower extremities), or 2 (if at least 1 point is from an upper extremity) at screening and/or baseline will be required to have a history of significant disability as defined by an INCAT disability score of 2 (must be exclusively from the lower extremities) or greater documented in the medical record. Participants will be eligible if one of the below eligibility criteria are met:
Screening and Baseline INCAT disability score of between 3 and 7 inclusive.
1. Screening and/or Baseline INCAT disability score of 2 (both points are from lower extremities).
2. Screening and/or Baseline INCAT disability score of 2 (both points are not from lower extremities) AND has at least a score of 2 or greater documented in the medical record prior to screening. If a score was greater than 2 documented in the medical record prior to screening at least 2 points must be from lower extremities.
3. Screening and/or Baseline INCAT disability score of 0 or 1 AND has at least a score of 2 or greater (both from lower extremities) documented in the medical record prior to screening, at least 2 points must be from lower extremities.
5. 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 (IP).
6. Participant is willing and able to sign an Informed Consent Form (ICF).
7. Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria
2. Any neuropathy of other causes, including:
1. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth \[CMT\] disease), and hereditary sensory and autonomic neuropathies (HSANs).
2. Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and non-diabetic lumbosacral radiculoplexus neuropathy, lymphoma, and amyloidosis.
3. Multifocal acquired demyelinating sensory and motor neuropathy (MADSAM).
4. Multifocal motor neuropathy (MMN).
5. 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 less than (\<) 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 greater than (\>) 100 millimeter of mercury (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 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2) estimated based on CKD-EPI equation (Levey et al., 2009) at the time of screening.
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 less than (\<) 10.0 grams per deciliter (g/dL) at screening.
13. Hypersensitivity or adverse reactions (AR's) (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 milligram per deciliter \[mg/dL\]) at screening.
16. Abnormal laboratory values at screening:
1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2.5\* upper limit of normal (ULN)
2. Platelet count \<100,000 cells per microliter (cells/mcL).
3. Absolute neutrophil count (ANC) \<1000 cells/mcL.
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 dose within 8 weeks prior to screening, regardless of indication.
20. Participant has undergone plasma exchange (PE) 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. Participant has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment, or is scheduled to participate in another clinical study (with the exception of the HYQVIA/HyQvia extension study in CIDP) involving an IP or investigational device during the course of this study.
24. The participant is a family member or employee of the investigator.
25. Participants with acquired or inherited thrombophilic disorders. These will include the specific types of acquired or inherited thrombophilic disorders that could put participants at risk of develop thrombotic events. Examples include:
a. Hereditary Thrombophilias i. Factor V Leiden mutation. ii. Prothrombin 20210A mutation. iii. Protein C deficiency. iv. Protein S deficiency. v. Antithrombin deficiency. b. Acquired thrombophilias i. Antiphospholipid antibody syndrome. ii. Activated protein C Resistance acquired. iii. Homocystinemia.
18 Years
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Shire
Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
Arizona Neuromuscular Research Center
Phoenix, Arizona, United States
HonorHealth Neurology
Scottsdale, Arizona, United States
University of California-Irvine
Orange, California, United States
Forbes Norris Mda/als Ctr
San Francisco, California, United States
Regents of the University of colorado
Aurora, Colorado, United States
Immunoe Research Centers
Centennial, Colorado, United States
University of South Florida
Tampa, Florida, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Neurology Center of Las Vegas
Las Vegas, Nevada, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Hospital for Special Surgery
New York, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Austin Neuromuscular Center
Austin, Texas, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
University Texas Physicians CAR
Houston, Texas, United States
Hospital Italiano
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, , Argentina
Complejo Medico de la Policia Federal Argentina Churruca Visca
Ciudad Autonoma Buenos Aires, , Argentina
Instituto de Investigaciones Neurologicas Raul Carrea, FLENI
Ciudad Autonoma Buenos Aires, , Argentina
Instituto de Neurologia de Curitiba - Hospital Ecoville
Curitiba, Paraná, Brazil
HUAP - UFF - Hospital Universitario Antonio Pedro - Universidade Federal Fluminense
Niterói, Rio Do Janeiro, Brazil
Hospital das Clínicas da Faculdade de Medicina da UNICAMP
Campinas, São Paulo, Brazil
Hospital das Clínicas FMRP-USP
Ribeirão Preto, São Paulo, Brazil
Hospital Sao Paulo
São Paulo, São Paulo, Brazil
University of Alberta Hospital
Edmonton, Alberta, Canada
LHSC - University Hospital
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"
Medellín, , Colombia
Clinical Hospital Centre Rijeka
Rijeka, , Croatia
Clinical Hospital Centar Zagreb
Zagreb, , Croatia
University Hospital Centre "Sestre Milosrdnice"
Zagreb, , Croatia
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Århus Universitetshospital
Aarhus, , Denmark
CHU de Nice Hôpital Pasteur 2
Nice, Alpes Maritimes, France
Hôpital de la Timone
Marseille, Bouches-du-Rhône, France
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux, Gironde, France
Hopital Neurologique Pierre Wertheimer
Bron, Rhone, France
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony, Germany
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony, Germany
University Hospital of Patra
Pátrai, , Greece
Chaim Sheba Medical Center
Ramat Gan, , Israel
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Roma, Italy
Azienda Ospedaliero Universitaria San Martino
Genova, , Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, , Italy
Casa di Cura del Policlinico
Milan, , Italy
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, , Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
Udine, , Italy
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
Mexico City, Mexico City, Mexico
Oslo Universitetssykehus HF, Ullevål
Oslo, , Norway
COPERNICUS Podmiot Leczniczy Sp. z o. o.,
Gdansk, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, , Poland
Clinical Center of Serbia
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Center Nis
Niš, , Serbia
Univerzitna nemocnica Bratislava Nemocnica ak. L. Derera, II. Neurologicka klinika
Bratislava, , Slovakia
Fakultna nemocnica Nitra
Nitra, , Slovakia
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hallands sjukhus
Halmstad, , Sweden
Pamukkale Uni. Med. Fac.
Denizli, , Turkey (Türkiye)
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University Faculty of Medicine
Izmir, , Turkey (Türkiye)
Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
Konya, , Turkey (Türkiye)
Celal Bayar University Medical Faculty
Manisa, , Turkey (Türkiye)
Southmead Hospital
Bristol, Avon, United Kingdom
King's College Hospital
London, Greater London, United Kingdom
The Walton Centre
Liverpool, Merseyside, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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2014-005496-87
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
161403
Identifier Type: -
Identifier Source: org_study_id
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