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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04051944
Other study ID # CIDP04
Secondary ID 2018-004392-12
Status Completed
Phase Phase 2
First received
Last updated
Start date August 21, 2019
Est. completion date November 10, 2021

Study information

Verified date October 2022
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to assess long-term safety and tolerability of weekly doses of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date November 10, 2021
Est. primary completion date November 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject who has completed one of the previous rozanolixizumab study(ies) that allow access to the present study (e.g. study CIDP01) - Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their final dose of investigational medicinal product (IMP) - Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the final administration of IMP Exclusion Criteria: - Subject has any medical (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could harm the subject or would compromise the subject's ability to participate in this study - Subject has a clinically relevant active infection (eg, sepsis, pneumonia, abscess) - Subject has a known hypersensitivity to any components of rozanolixizumab - Subject intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of rozanolixizumab - Subject has an ongoing serious adverse event (SAE) or a medical condition in the parent study that the investigator considers to put the subject at a significantly increased risk of participating in CIDP04 - Subject has any planned elective surgery due to occur during the study dosing period which in the opinion of the investigator could interfere with study procedures

Study Design


Related Conditions & MeSH terms

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
  • Polyradiculoneuropathy
  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Drug:
Rozanolixizumab
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.

Locations

Country Name City State
Belgium Cidp04 40169 Gent
Belgium Cidp04 40002 Leuven
Belgium Cidp04 40120 Liège
Denmark Cidp04 40126 Copenhagen
France Cidp04 40170 Strasbourg
Germany Cidp04 40134 Essen
Germany Cidp04 40140 Göttingen
Netherlands Cidp04 40034 Amsterdam
Spain Cidp04 40160 Barcelona
United Kingdom Cidp04 40167 Sheffield
United States Cidp04 50075 Augusta Georgia
United States Cidp04 50117 Charlotte North Carolina
United States Cidp04 50080 Durham North Carolina
United States Cidp04 50082 Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment-emergent Adverse Event (TEAEs) An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as any event that was not present prior the first administration of investigational medicinal product (IMP) in CIDP04 study or any unresolved event already present before the first administration of IMP in CIDP04 study that worsened in intensity following exposure to treatment until 8 weeks following the last administration of IMP in CIDP04 study. From Baseline until Follow-Up Visit (up to Week 84)
See also
  Status Clinical Trial Phase
Completed NCT05363358 - A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Completed NCT03864185 - The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies Phase 2
Completed NCT03861481 - A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Phase 2
Active, not recruiting NCT05084053 - A Study of TAK-771 in Japanese Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) Phase 3