A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Study Details
Study Description
Brief Summary
The aim of this study is to learn more about the following treatment options in adults with
CIDP:
-
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Phase III Efficacy, Safety, and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDP
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Epoch 1: HYQVIA/HyQvia Participants will receive HYQVIA/HyQvia at a dose of 80 Unit per gram (U/g) SC immunoglobulin (IgG) which will be same as the participants pre-randomization monthly equivalent IgG dose (or at matching infusion volume for participants in the placebo group) when administered at a dosing frequency of every 2, 3, or 4 weeks for 6 months or until relapse. |
Biological: HYQVIA
Participants will receive HYQVIA/HyQvia SC which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).
Other Names:
|
| Placebo Comparator: Epoch 1: Placebo with rHuPH20 Participants will receive sequential 0.25% albumin placebo with rHuPH20 at a dose of 80U/g IgG SC for 6 months or until relapse. Dosing regimen for placebo treatment will be the same as the participant's pre-randomization monthly equivalent IgG infusion volume when administered every 2, 3, or 4 weeks. |
Biological: 0.25% albumin placebo solution with rHuPH20
Participants will receive placebo solution (0.25% human albumin in Lactated Ringer's solution) and rHuPH20.
|
| Experimental: Epoch 2: IGIV Participants will receive an induction dose of 2 gram per kilogram (g/kg) Intravenous immunoglobulin G (IGIV), followed by maintenance infusions at the same monthly dose as the participant's pre-randomization IgG dose, every 3 weeks for 6 months or until relapse. |
Biological: IGIV
Participants will receive GAMMAGARD LIQUID/KIOVIG (all participants with the exception of those at US sites) or GAMUNEX®-C (participants at US sites only).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Pre-SC Baseline Week 1 [Pre-SC Baseline (Week 1)]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of greater than or equal to (>=)1 point relative to the pre- subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 5 [Week 5]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 9 [Week 9]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 13 [Week 13]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 15 [Week 15]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 19 [Week 19]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 23 [Week 23]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 27 (End of Epoch 1 Treatment [EOE1T])/Unscheduled relapse visit assessment (UV)/Early Termination (ET) [Week 27 (EOET1)/UV/ET]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Pre-SC Baseline [Pre-SC Baseline]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 5 [Week 5]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 8 [Week 8]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 11 [Week 11]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 14 [Week 14]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 17 [Week 17]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 20 [Week 20]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 23 [Week 23]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 26 (EOE1T)/Unscheduled relapse visit assessment (UV)/Early Termination (ET) [Week 26 (EOE1T)/UV/ET]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Pre-SC Baseline [Pre-SC Baseline]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 5 [Week 5]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 8 [Week 8]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 12 [Week 12]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 16 [Week 16]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 20 [Week 20]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 24 [Week 24]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 28 (EOET1)/Unscheduled relapse visit assessment (UV)/Early Termination (ET) [Week 28 (EOET1)/UV/ET]
Relapse rate is defined as proportion of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre-SC treatment baseline score in 2 consecutive adjusted INCAT disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
- Epoch 2: Responder Rate on Every 3 Weeks Dosing Regimen at Pre-Baseline (Week 1) [Pre-IV Baseline (Week 1)]
Responder rate is defined as clinically meaningful improvement in functional ability defined as a decrease of >=1 point in the adjusted INCAT disability score at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.
- Epoch 2: Responder Rate on Every 3 Weeks Dosing Regimen up to 6 Months (End of Epoch 2 Treatment [EOE2T])/Unscheduled visit assessment (UV)/Early Termination [Up to 6 Months/UV/ET]
Responder rate is defined as clinically meaningful improvement in functional ability defined as a decrease of >=1 point in the adjusted INCAT disability score at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.
Secondary Outcome Measures
- Epoch 1: Percentage of Participants Who Experience a Worsening of Functional Disability [Throughout Epoch 1, up to 6 months]
Defined as one or more of the following: an increase of >=1 point relative to the pre-subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) scores; who experience chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) worsening (defined as a >=8 kilo Pascal (kPa) decrease in the hand grip strength in the more affected hand); >=4 points decrease in Rasch-built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score (at the time of withdrawal from the SC treatment period).
- Epoch 1: Time to Relapse [Throughout Epoch 1, up to 6 months]
Time to relapse is defined as time from the date of the first SC administration of HYQVIA/HyQvia or placebo with rHuPH20 to the date of relapse.
- Epoch 1: Change From Pre-Subcutaneous (SC) Treatment Baseline in Rasch-built Overall Disability Scale (R-ODS) [Pre-subcutaneous (SC) treatment baseline, then weekly through Epoch 1 (up to 6 months); Unscheduled relapse visit assessment; & if early termination occurs.]
The Rasch-Built Overall Disability Scale (R-ODS) is a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participant with immune-mediated peripheral neuropathies including chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (ie, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion.
- Epoch 1: Number of Participants Experiencing Any Treatment-Emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality [Throughout Epoch 1, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
- Epoch 1: Number of Participants Experiencing Causally Related Serious and/or Non-Serious Adverse Events (SAEs and/or AEs) [Throughout Epoch 1, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
- Epoch 1: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs [Throughout Epoch 1, up to 6 months]
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
- Epoch 1: Number of Participants With Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality [Throughout Epoch 1, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
- Epoch 1: Number of Participants With Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions [Throughout Epoch 1, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
- Epoch 1: Number of Participants With Adverse Events (AEs) Temporally Associated With Infusions [During an infusion or within 72 hours after completion of an infusion]
AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 1: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) plus Suspected ARs Associated With Infusions [Throughout Epoch 1, up to 6 months]
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
- Epoch 1: Number of Participants With Treatment-emergent Systemic Adverse Events (AEs) Associated With Infusions [Throughout Epoch 1, up to 6 months]
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.
- Epoch 1: Number of Participants With Treatment-emergent Local Infusion Site Reactions Associated With Infusions [Throughout Epoch 1, up to 6 months]
A TEAE is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.
- Epoch 1: Number of Infusions for Which the Infusion Rate Was Reduced And/Or the Infusion Was Interrupted or Stopped Due to Intolerability And/Or Adverse Events (AEs) [Throughout Epoch 1, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion [Throughout Epoch 1, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events per Participant [Throughout Epoch 1, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events per Participant-year [Throughout Epoch 1, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion [Throughout Epoch 1, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Participant [Throughout Epoch 1, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events per Participant-year [Throughout Epoch 1, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events per Infusion [Throughout Epoch 1, up to 6 months]
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.
- Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events per Participant [Throughout Epoch 1, up to 6 months]
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.
- Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events per Participant-Year [Throughout Epoch 1, up to 6 months]
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.
- Epoch 1: Number of Participants Who Develop Binding and/or Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20) [Throughout Epoch 1, up to 6 months]
Number of participants who develop binding and/or neutralizing antibodies to rHuPH20 in Epoch 1 will be reported.
- Epoch 2: Number of Participants Experiencing Any Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality [Throughout Epoch 2, up to 6 months]
Number of participants experiencing any treatment-emergent serious and/or non-serious adverse events regardless of causality in Epoch 2 will be reported.
- Epoch 2: Number of Participants Experiencing Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) [Throughout Epoch 2, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
- Epoch 2: Number of Participants with Serious and/or Non-serious Adverse Reactions (ARs) plus Suspected ARs [Throughout Epoch 2, up to 6 months]
A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.
- Epoch 2: Number of Participants With Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality [Throughout Epoch 2, up to 6 months]
A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.
- Epoch 2: Number of Participants With Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions [Throughout Epoch 2, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
- Epoch 2: Number of Participants With Adverse Events (AEs) Temporally Associated With Infusions [During an infusion or within 72 hours after completion of an infusion]
AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 2: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) plus Suspected ARs Associated With Infusions [Throughout Epoch 2, up to 6 months]
A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.
- Epoch 2: Number of Participants With Treatment-emergent Systemic Adverse Events (AEs) Associated With Infusions [Throughout Epoch 2, up to 6 months]
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.
- Epoch 2: Number of Participants With Treatment-emergent Local Infusion Site Reactions Associated With Infusions [Throughout Epoch 2, up to 6 months]
A TEAE is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.
- Epoch 2: Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or Adverse Events (AEs) [Throughout Epoch 2, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion [Throughout Epoch 2, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant [Throughout Epoch 2, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant-year [Throughout Epoch 2, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion [Throughout Epoch 2, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant [Throughout Epoch 2, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-Year [Throughout Epoch 2, up to 6 months]
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
- Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Ars, Expressed as Number of Events Per Infusion [Throughout Epoch 2, up to 6 months]
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.
- Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events Per Participant [Throughout Epoch 2, up to 6 months]
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.
- Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events Per Participant-Year [Throughout Epoch 2, up to 6 months]
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate.
- Epoch 2: Percentage of Participants With Clinically Meaningful Improvement in Functional Ability [Throughout Epoch 2, up to 6 months]
Defined as one or more of the following: a decrease of >=1 point in the adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) score at 2 consecutive time points; who experience chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) improvement (defined as ≥8 kilo Pascal (kPa) increase in hand grip strength in the more affected hand; >=4 points increase in Rasch-built Overall Disability Scale (R-ODS)) at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males or females of age greater than or equal to (>=)18 years old at the time of screening.
-
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.
-
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.
-
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.
-
Screening and/or Baseline INCAT disability score of 2 (both points are from lower extremities).
-
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.
-
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.
-
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).
-
Participant is willing and able to sign an Informed Consent Form (ICF).
-
Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria:
-
Participants with Focal atypical CIDP or pure sensory atypical CIDP.
-
Any neuropathy of other causes, including:
-
Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth [CMT] disease), and hereditary sensory and autonomic neuropathies (HSANs).
-
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.
-
Multifocal acquired demyelinating sensory and motor neuropathy (MADSAM).
-
Multifocal motor neuropathy (MMN).
-
Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy.
-
Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titer antibodies to myelin-associated glycoprotein.
-
Prominent sphincter disturbance.
-
Central demyelinating disorders (eg, multiple sclerosis).
-
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).
-
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).
-
History of deep vein thrombosis or thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) in the past 12 months.
-
Condition(s) which could alter protein catabolism and/or IgG utilization (eg, protein-losing enteropathies, nephrotic syndrome).
-
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.
-
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.
-
Clinically significant anemia or hemoglobin (Hgb) level of less than (<) 10.0 grams per deciliter (g/dL) at screening.
-
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.
-
Known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin (such as bee or wasp venom).
-
Known history of or immunoglobulin A (IgA) deficiency (<8 milligram per deciliter [mg/dL]) at screening.
-
Abnormal laboratory values at screening:
-
Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5* upper limit of normal (ULN)
-
Platelet count <100,000 cells per microliter (cells/mcL).
-
Absolute neutrophil count (ANC) <1000 cells/mcL.
-
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.
-
The participant has received or is currently receiving treatment with immunomodulatory/ immunosuppressive agents within 6 months prior to screening.
-
Participant has received or is currently receiving treatment with corticosteroids dose within 8 weeks prior to screening, regardless of indication.
-
Participant has undergone plasma exchange (PE) within 3 months prior to screening.
-
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.
-
The participant is nursing or intends to begin nursing during the course of the study.
-
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.
-
The participant is a family member or employee of the investigator.
-
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:
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Barrow Neurological Institute | Phoenix | Arizona | United States | 85013 |
| 2 | Arizona Neuromuscular Research Center | Phoenix | Arizona | United States | 85028 |
| 3 | HonorHealth Neurology | Scottsdale | Arizona | United States | 85251 |
| 4 | University of California-Irvine | Orange | California | United States | 92868 |
| 5 | Forbes Norris Mda/als Ctr | San Francisco | California | United States | 94109 |
| 6 | Regents of the University of colorado | Aurora | Colorado | United States | 80045 |
| 7 | Immunoe Research Centers | Centennial | Colorado | United States | 80112 |
| 8 | University of South Florida | Tampa | Florida | United States | 33612 |
| 9 | University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | United States | 66160 |
| 10 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073-6769 |
| 11 | Neurology Center of Las Vegas | Las Vegas | Nevada | United States | 89128 |
| 12 | Rutgers New Jersey Medical School | Newark | New Jersey | United States | 07103 |
| 13 | Hospital for Special Surgery | New York | New York | United States | 10032 |
| 14 | Wake Forest University | Winston-Salem | North Carolina | United States | 27157 |
| 15 | University of Cincinnati | Cincinnati | Ohio | United States | 45267-0525 |
| 16 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 17 | Austin Neuromuscular Center | Austin | Texas | United States | 78756 |
| 18 | The Methodist Hospital Research Institute | Houston | Texas | United States | 77030 |
| 19 | University Texas Physicians CAR | Houston | Texas | United States | 77030 |
| 20 | Hospital Italiano | Ciudad Autonoma Buenos Aires | Buenos Aires | Argentina | C1181ACH |
| 21 | Hospital Britanico de Buenos Aires | Ciudad Autonoma Buenos Aires | Argentina | 1280 | |
| 22 | Complejo Medico de la Policia Federal Argentina Churruca Visca | Ciudad Autonoma Buenos Aires | Argentina | 1416 | |
| 23 | Instituto de Investigaciones Neurologicas Raul Carrea, FLENI | Ciudad Autonoma Buenos Aires | Argentina | C1428AQK | |
| 24 | Instituto de Neurologia de Curitiba - Hospital Ecoville | Curitiba | Paraná | Brazil | 81210-310 |
| 25 | HUAP - UFF - Hospital Universitario Antonio Pedro - Universidade Federal Fluminense | Niterói | Rio Do Janeiro | Brazil | 24033-900 |
| 26 | Hospital das Clínicas da Faculdade de Medicina da UNICAMP | Campinas | Sao Paulo | Brazil | 13083-887 |
| 27 | Hospital das Clínicas FMRP-USP | Ribeirão Preto | Sao Paulo | Brazil | 14048-900 |
| 28 | Hospital Sao Paulo | São Paulo | Sao Paulo | Brazil | 04039-032 |
| 29 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2B7 |
| 30 | LHSC - University Hospital | London | Ontario | Canada | N6A 5A5 |
| 31 | Toronto General Hospital | Toronto | Ontario | Canada | M5G 2C4 |
| 32 | Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA" | Medellin | Colombia | 00000 | |
| 33 | Clinical Hospital Centre Rijeka | Rijeka | Croatia | 51000 | |
| 34 | Clinical Hospital Centar Zagreb | Zagreb | Croatia | 10000 | |
| 35 | University Hospital Centre "Sestre Milosrdnice" | Zagreb | Croatia | 10000 | |
| 36 | Fakultni nemocnice Brno | Brno | Czechia | 625 00 | |
| 37 | Fakultni nemocnice Ostrava | Ostrava - Poruba | Czechia | 708 52 | |
| 38 | Fakultni nemocnice v Motole | Praha 5 | Czechia | 150 06 | |
| 39 | Århus Universitetshospital | Aarhus | Denmark | 8000 | |
| 40 | CHU de Nice Hôpital Pasteur 2 | Nice Cedex 1 | Alpes Maritimes | France | 06001 |
| 41 | Hôpital de la Timone | Marseille cedex 5 | Bouches-du-Rhône | France | 13385 |
| 42 | Groupe Hospitalier Pellegrin - Hôpital Pellegrin | Bordeaux Cedex | Gironde | France | 33076 |
| 43 | Hopital Neurologique Pierre Wertheimer | Bron cedex | Rhone | France | 69677 |
| 44 | Universitaetsmedizin Goettingen | Göttingen | Niedersachsen | Germany | 37075 |
| 45 | Universitaetsklinikum Essen | Essen | Nordrhein Westfalen | Germany | 45147 |
| 46 | Universitaetsklinikum Leipzig AoeR | Leipzig | Sachsen | Germany | 04103 |
| 47 | University Hospital of Patra | Patras | Greece | 26504 | |
| 48 | Chaim Sheba Medical Center | Ramat Gan | Israel | 5265601 | |
| 49 | IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Foggia | Italy | 71013 |
| 50 | Istituto Clinico Humanitas | Rozzano | Milano | Italy | 20089 |
| 51 | Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Rome | Roma | Italy | 00133 |
| 52 | Azienda Ospedaliero Universitaria San Martino | Genova | Italy | 16132 | |
| 53 | Azienda Ospedaliera Universitaria Policlinico G. Martino | Messina | Italy | 98122 | |
| 54 | Casa di Cura del Policlinico | Milano | Italy | 20144 | |
| 55 | Fondazione Istituto Neurologico Casimiro Mondino | Pavia | Italy | 27100 | |
| 56 | Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | 56126 | |
| 57 | Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza | Roma | Italy | 00161 | |
| 58 | Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | Italy | 10126 | |
| 59 | Azienda Ospedaliero-Universitaria Santa Maria della Misericordia | Udine | Italy | 33100 | |
| 60 | Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran | Mexico | Distrito Federal | Mexico | 14080 |
| 61 | Oslo Universitetssykehus HF, Ullevål | Oslo | Norway | 0407 | |
| 62 | COPERNICUS Podmiot Leczniczy Sp. z o. o., | Gdansk | Poland | 80-803 | |
| 63 | Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | 80-952 | |
| 64 | Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie | Lublin | Poland | 20-090 | |
| 65 | Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego | Łódź | Poland | 90-153 | |
| 66 | Clinical Center of Serbia | Belgrade | Serbia | 11000 | |
| 67 | Military Medical Academy | Belgrade | Serbia | 11000 | |
| 68 | Clinical Center Nis | Nis | Serbia | 18000 | |
| 69 | Univerzitna nemocnica Bratislava Nemocnica ak. L. Derera, II. Neurologicka klinika | Bratislava | Slovakia | 83101 | |
| 70 | Fakultna nemocnica Nitra | Nitra | Slovakia | 95001 | |
| 71 | Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | Spain | 08907 |
| 72 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | 08025 | |
| 73 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
| 74 | Hospital Universitario Virgen del Rocio | Sevilla | Spain | 41013 | |
| 75 | Hallands sjukhus | Halmstad | Sweden | 302 33 | |
| 76 | Pamukkale Uni. Med. Fac. | Denizli | Turkey | 20070 | |
| 77 | Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty | Istanbul | Turkey | 34098 | |
| 78 | Dokuz Eylul University Faculty of Medicine | Izmir | Turkey | 35340 | |
| 79 | Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi | Konya | Turkey | 42075 | |
| 80 | Celal Bayar University Medical Faculty | Manisa | Turkey | 45040 | |
| 81 | Southmead Hospital | Bristol | Avon | United Kingdom | BS10 5NB |
| 82 | King's College Hospital | London | Greater London | United Kingdom | SE5 9RS |
| 83 | The Walton Centre | Liverpool | Merseyside | United Kingdom | L9 7LJ |
Sponsors and Collaborators
- Baxalta now part of Shire
- Takeda Development Center Americas, Inc.
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 161403
- 2014-005496-87