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A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (MyCIDPchoice)

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ClinicalTrials.gov Identifier: NCT03861481
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief Summary:
The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

Condition or disease Intervention/treatment Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Drug: Rozanolixizumab Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: Rozanolixizumab
Subjects will be randomized to receive predefined subcutaneous doses of rozanolixizumab at a specified frequency
Drug: Rozanolixizumab
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.

Placebo Comparator: Placebo
Subjects will be randomized to receive predefined subcutaneous doses of placebo at a specified frequency
Other: Placebo
Subjects will receive placebo in a specified sequence during the treatment period.




Primary Outcome Measures :
  1. Change from Baseline to Week 13 (Day 85) in inflammatory Rasch-built Overall Disability Scale (iRODS) score [ Time Frame: From Baseline up to Week 13 (Day 85) ]
    The Rasch-built Overall Disability Scale (iRODS) is an instrument answered by the patient to assess overall disability. Patients are asked to rate their ability to perform everyday tasks (ie, able to perform without difficulties, able to perform but with difficulties, not able to perform). The iRODS consists of 24 items. The raw sum score ranges from 0 to 48 and will be translated to log odds units (logits), placing patients' estimates on the same logit scale. For easier interpretation the person locations can be translated to values changing from 0 (most severe activity and social participation restrictions) to 100 (no activity and social participation limitations).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861481


Contacts
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Contact: UCB Cares +1844599 ext 2273 UCBCares@ucb.com

Locations
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United States, California
Cidp01 905 Recruiting
Los Angeles, California, United States, 90033
United States, Florida
Cidp01 901 Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Cidp01 907 Recruiting
Augusta, Georgia, United States, 30912
United States, Kansas
Cidp01 904 Recruiting
Fairway, Kansas, United States, 66205
United States, North Carolina
Cidp01 903 Recruiting
Charlotte, North Carolina, United States, 28210
United States, Ohio
Cidp01 909 Recruiting
Columbus, Ohio, United States, 43210
Belgium
Cidp01 101 Recruiting
Gent, Belgium
Cidp01 102 Recruiting
Leuven, Belgium
France
Cidp01 402 Recruiting
Bordeaux, France
Germany
Cidp01 501 Recruiting
Berlin, Germany
Cidp01 505 Recruiting
Göttingen, Germany
Spain
Cidp01 701 Recruiting
Barcelona, Spain
Cidp01 702 Recruiting
Barcelona, Spain
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares +1 844 599 2273 (UCB)

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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03861481     History of Changes
Other Study ID Numbers: CIDP01
2016-002411-17 ( EudraCT Number )
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal
URL: https://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Chronic inflammatory demyelinating polyradiculoneuropathy
CIDP
UCB7665
rozanolixizumab
Additional relevant MeSH terms:
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Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases