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NCT03861481 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
A Phase 2 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), sponsored by UCB Biopharma S.P.R.L..
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 20
- Study locations
NCT03861481: Completed Phase 2 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), sponsored by UCB Biopharma S.P.R.L..
NCT03861481 is a Phase 2 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) that has completed, run by UCB Biopharma S.P.R.L.. The registered enrollment target is 34 participants, below the 42-participant average among 3 other Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03861481, a Phase 2 study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), has completed, sponsored by UCB Biopharma S.P.R.L..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Rozanolixizumab
Study Locations (20)
Other
- Cidp01 101 - Ghent
- Cidp01 102 - Leuven
- Cidp01 103 - Liège
- Cidp01 302 - Copenhagen
- Cidp01 402 - Bordeaux
- Cidp01 404 - Nice
- Cidp01 401 - Strasbourg
- Cidp01 501 - Berlin
- Cidp01 503 - Essen
- Cidp01 505 - Göttingen
- Cidp01 502 - Würzburg
- Cidp01 601 - Amsterdam
- Cidp01 701 - Barcelona
North Carolina
- Cidp01 903 - Charlotte
- Cidp01 912 - Durham
Arizona
- Cidp01 902 - Phoenix
California
- Cidp01 905 - Los Angeles
Florida
- Cidp01 901 - Tampa
Georgia
- Cidp01 907 - Augusta
Kentucky
- Cidp01 911 - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-03-26 |
| Est. Completion | 2021-03-31 |
| Phase | Phase 2 |
What the finished NCT03861481 record still lists
NCT03861481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 42-participant average among 3 other Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03861481 names 20 study sites across 7 states, led by Other, North Carolina, Arizona.
Frequently Asked Questions
What is clinical trial NCT03861481 about?
NCT03861481 is a clinical study titled "A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy". The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
What is the current status of trial NCT03861481?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2019-03-26. Estimated completion is 2021-03-31.
What conditions does trial NCT03861481 study?
This clinical trial studies the following conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).
What interventions are being tested in trial NCT03861481?
The interventions under investigation include: Placebo (OTHER), Rozanolixizumab (DRUG).
Who is sponsoring clinical trial NCT03861481?
This trial is sponsored by UCB Biopharma S.P.R.L., which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03861481 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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