Phase 3 N=85 Treatment

Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Bottom Line

View on ClinicalTrials.gov: NCT02955355 ↗

Enrolled (actual)

Serious AEs

23.5%

Results posted

Aug 2024

Primary outcome: Primary: Number of Participants With Any Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), Regardless of Causality — 76; 20 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: HYQVIA (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baxalta now part of Shire
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Any Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), Regardless of Causality	76; 20	—
PRIMARY Number of Participants With Causally Related Treatment-emergent SAEs and AEs	51; 3	—
PRIMARY Number of Participants With Adverse Reactions (ARs) or Suspected Adverse Reactions (SARs) Categorized as Serious and Non-serious	7; 57	—
PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events That May be a Result of Immune-Mediated Responses	7.1	—
PRIMARY Number of Treatment-Emergent SAEs and AEs Associated With Infusions, Regardless of Causality	30; 1406	—
PRIMARY Number of Causally Related Treatment-Emergent SAEs and AEs Associated With Infusions	3; 798	—
PRIMARY Number of TEAEs Temporally Associated With Infusions	857	—
PRIMARY Number of Serious and Non-Serious ARs or SARs Associated With Infusions	8; 913	—
PRIMARY Number of Infusions Associated With One or More Systemic TEAEs	50	—
PRIMARY Number of Infusions Associated With One or More Local TEAEs	17	—
PRIMARY Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or TEAEs	3	—
PRIMARY Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per Infusion	0.25; 0.15	—
PRIMARY Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per Participant	10.38; 6.16	—
PRIMARY Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year	4000.23; 2376.55	—
PRIMARY Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per Infusion	0.08; 0.15	—
PRIMARY Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per Participant	3.38; 6.01	—
PRIMARY Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per 1000 Participant-year	1301.66; 2317.59	—
PRIMARY Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per Infusion	0.11; 0.15	—
PRIMARY Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per Participant	4.58; 6.16	—
PRIMARY Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per 1000 Participant-year	1764.27; 2376.55	—
PRIMARY Number of Participants With a TEAE That Led to Discontinuation From Study	4	—
PRIMARY Number of Participants With Moderate or Severe TEAEs That May be a Result of Immune-Mediated Responses	3	—
PRIMARY Rate of Moderate or Severe TEAEs That May be a Result of Immune-Mediated Responses, Expressed as Number of Events Per 100 Infusions	0.0860	—
PRIMARY Number of Participants That Experienced Treatment-Emergent Local Infusion Site Reactions	30	—
PRIMARY Number of Participants With Treatment-Emergent Local Tolerability Events During Ramp-up	6; 13	—
PRIMARY Number of Participants With Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate Per Site, and Infusion Volume Per Site	8; 22; 15; 15; 15; 15	—
PRIMARY Number of Participants Whose Anti-Hyaluronidase Binding Antibody Titers Rose by ≥4-fold From Baseline	16	—
PRIMARY Number of Participants With Binding Antibodies to rHuPH20	14	—
PRIMARY Number of Participants With Neutralizing Antibodies Binding to rHuPH20	2	—
PRIMARY Number of Participants With a Decline of Anti-rHuPH20 Binding Antibody Titers to the Antibody Titer Level at Baseline in Study 161403 or to <1:160 Antibody Titer Level at the Study Completion or Early Discontinuation	12	—
PRIMARY Number of Participants Who Had >1:10,000 Anti-rHuPH20 Binding Antibody Titers With Neutralizing Antibodies	2	—
SECONDARY Number of Participants Who Had >1:10,000 Anti-rHuPH20 Binding Antibody Titers Showing Cross Reactivity With Hyaluronidase (Hyal)-1,2 and 4	—	—

Summary

Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have completed study 161403 will be able to take part in this study. The main aim of the study is to evaluate side effects in the long-term treatment with HYQVIA/HyQvia. All participants will receive HYQVIA/HyQvia in the same way as they were receiving in study 161403. The dosing interval of HYQVIA/HyQvia can be adjusted after 12 weeks of treatment in study 161505 if the study doctor determines that it is safe to do so. Participants will visit the clinic within 1 week after the first and second dose of HYQVIA/HyQvia and then every 12 weeks for the duration of the study.

Eligibility Criteria

Inclusion Criteria

Has completed Epoch 1 of Study 161403 without CIDP worsening.
If female of childbearing potential, the participant must have a negative pregnancy test at baseline and agree to employ adequate birth control measures (eg, birth control pills/patches, intrauterine device, or diaphragm or condom [for male partner] with spermicidal jelly or foam) throughout the course of the study.

Exclusion Criteria

Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this Extension Study.
New medical condition that developed during participation in study 161403 that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of investigational medicinal product (IMP) and/or conduct of the study.
Participant is scheduled to participate in another non-Baxalta clinical study involving an IP or investigational device during the course of this 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 investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study (with the exception of study 161403) involving an IP or investigational device during the course of this study.
The participant is a family member or employee of the investigator.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02955355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.