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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03861481
Other study ID # CIDP01
Secondary ID 2016-002411-17
Status Completed
Phase Phase 2
First received
Last updated
Start date March 26, 2019
Est. completion date March 31, 2021

Study information

Verified date July 2023
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 evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject is = 18 years of age with a minimum body weight of =42 kg at Visit 1 (Screening) - Subject has a documented definite or probable diagnosis of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) according to the European Federation of Neurological Societies (EFNS)/ Peripheral Nerve Society (PNS) criteria 2010 - Subject has an immunoglobulin-dependency confirmed by clinical examination during therapy or upon interruption or reduction of therapy within 18 months prior to Screening and documented in medical history - Subject is on a stable dosage (not more than ±20% deviation) for subcutaneous immunoglobulin (SCIg) or intravenous immunoglobulin (IVIg) and a fixed interval for at least 4 months of either treatment - 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: - Previously received treatment in this study or subject has previously been exposed to rozanolixizumab - Current diagnosis or has a history of Type 1 or Type 2 diabetes mellitus and/or hemoglobin A1c level >6.0 % - Known immunoglobulin M (IgM)-mediated neuropathy - Clinical or known evidence of associated systemic diseases that might cause neuropathy or treatment with agents that might lead to neuropathy - History of clinically relevant ongoing chronic infections - Family history of primary immunodeficiency - Received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP - Received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline - Prior treatment with rituximab, ofatumumab, or ocrelizumab in the 6 months prior to the Baseline Visit or subject has had prior treatment with rituximab, ofatumumab, or ocrelizumab in the 12 months prior to Baseline and B cells are not within the normal range - Female subject who is pregnant or lactating

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.
Other:
Placebo
Subjects will receive placebo in a specified sequence during the treatment period.

Locations

Country Name City State
Belgium Cidp01 101 Gent
Belgium Cidp01 102 Leuven
Belgium Cidp01 103 Liège
Denmark Cidp01 302 Copenhagen
France Cidp01 402 Bordeaux
France Cidp01 404 Nice
France Cidp01 401 Strasbourg
Germany Cidp01 501 Berlin
Germany Cidp01 503 Essen
Germany Cidp01 505 Göttingen
Germany Cidp01 502 Würzburg
Netherlands Cidp01 601 Amsterdam
Spain Cidp01 701 Barcelona
Spain Cidp01 702 Barcelona
United Kingdom Cidp01 802 Sheffield
United States Cidp01 907 Augusta Georgia
United States Cidp01 903 Charlotte North Carolina
United States Cidp01 912 Durham North Carolina
United States Cidp01 911 Lexington Kentucky
United States Cidp01 905 Los Angeles California
United States Cidp01 902 Phoenix Arizona
United States Cidp01 901 Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
UCB Biopharma S.P.R.L.

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 Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score iRODS is a linearly weighted patient-reported outcome measure (questionnaire) that captures activity and social participation limitations in participants with chronic inflammatory demyelinating polyradiculoneuropathy. Questionnaire consisted of 24 items (including eating, taking a shower, walking a flight of stairs, standing for hours, etc.) and assesses a participant's ability to perform daily and social activities. Participants had 3 response options: 0=impossible to perform; 1=performed with difficulty; 2=easily performed, performed without difficulty. Raw sum scores of iRODS (range 0 to 48, where 0=worse and 48=best) were translated to log odds units (logits) scale, placing participant' estimates on same logit scale, which had a score range of -6.95 (most severe activity and social participation restrictions) to 8.11 (no activity and social participation limitations). A positive change is associated with a better outcome of less disease activity and more social activity. From Baseline up to Week 13 (Day 85)
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
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
Completed NCT04051944 - A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Phase 2