Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Clinical Trial
— MyCIDPchoiceOfficial title:
A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Verified date | July 2023 |
Source | UCB Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
UCB Biopharma S.P.R.L. |
United States, Belgium, Denmark, France, Germany, Netherlands, Spain, United Kingdom,
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) |
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