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Trial record 1 of 1 for:    CIDP01
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A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (MyCIDPchoice)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03861481
Recruitment Status : Completed
First Posted : March 4, 2019
Results First Posted : April 4, 2022
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Interventions Drug: Rozanolixizumab
Other: Placebo
Enrollment 34
Recruitment Details The study started to enroll study participants in March 2019 and concluded in March 2021.
Pre-assignment Details Participant Flow refers to the Randomized Set.
Arm/Group Title Placebo Rozanolixizumab
Hide Arm/Group Description Participants received placebo matched to rozanolixizumab as a subcutaneous injection once weekly for 12 weeks. Participants received rozanolixizumab Dose A as a subcutaneous injection once weekly for 12 weeks.
Period Title: Overall Study
Started 17 17
Completed 11 10
Not Completed 6 7
Reason Not Completed
COVID-19 pandemic circumstances             0             1
Participant not plan to participate in the study CIDP04             1             0
Relapse             1             0
Withdrawal by Subject             0             1
Lack of Efficacy             4             5
Arm/Group Title Placebo Rozanolixizumab Total
Hide Arm/Group Description Participants received placebo matched to rozanolixizumab as a subcutaneous injection once weekly for 12 weeks. Participants received rozanolixizumab Dose A as a subcutaneous injection once weekly for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
The Randomized Set consisted of all participants randomized into the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  94.1%
12
  70.6%
28
  82.4%
>=65 years
1
   5.9%
5
  29.4%
6
  17.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
56.4  (7.4) 57.3  (13.3) 56.8  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
8
  47.1%
8
  47.1%
16
  47.1%
Male
9
  52.9%
9
  52.9%
18
  52.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Asian
1
   5.9%
0
   0.0%
1
   2.9%
Black
1
   5.9%
1
   5.9%
2
   5.9%
White
11
  64.7%
15
  88.2%
26
  76.5%
Other/mixed
4
  23.5%
1
   5.9%
5
  14.7%
1.Primary Outcome
Title Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score
Hide Description 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.
Time Frame From Baseline up to Week 13 (Day 85)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all participants who received at least one dose of treatment and who had a Baseline and at least one valid post-Baseline iRODS measurement up to Week 13 (Day 85)/premature end of treatment (inclusively).
Arm/Group Title Placebo Rozanolixizumab
Hide Arm/Group Description:
Participants received placebo matched to rozanolixizumab as a subcutaneous injection once weekly for 12 weeks.
Participants received rozanolixizumab Dose A as a subcutaneous injection once weekly for 12 weeks.
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale (logits)
0.234  (0.379) 0.181  (0.468)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rozanolixizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference (Rozimab - Placebo)
Estimated Value -0.052
Confidence Interval (2-Sided) 90%
-0.892 to 0.788
Estimation Comments MMRM analysis (fixed effect terms: treatment, baseline iRODS score, prior Ig therapy administration route, assessment week, treatment by week interaction; random effect term: study participant). LS Mean Difference > 0 favours rozanolixizumab.
Time Frame From Baseline until the Safety Follow-up Visit (up to Week 24)
Adverse Event Reporting Description A TEAE is defined as any event that was not present prior the first administration of IMP or any unresolved event already present before the first administration of IMP that worsens in intensity following exposure to treatment until 8 weeks following the last administration of IMP.
 
Arm/Group Title Placebo Rozanolixizumab
Hide Arm/Group Description Participants received placebo matched to rozanolixizumab as a subcutaneous injection once weekly for 12 weeks. Participants received rozanolixizumab Dose A as a subcutaneous injection once weekly for 12 weeks.
All-Cause Mortality
Placebo Rozanolixizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)      0/17 (0.00%)    
Hide Serious Adverse Events
Placebo Rozanolixizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      2/17 (11.76%)    
Nervous system disorders     
Chronic inflammatory demyelinating polyradiculoneuropathy * 1  0/17 (0.00%)  0 2/17 (11.76%)  2
1
Term from vocabulary, MedDRA v24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Rozanolixizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/17 (82.35%)      15/17 (88.24%)    
Gastrointestinal disorders     
Diarrhoea * 1  3/17 (17.65%)  5 2/17 (11.76%)  2
Nausea * 1  2/17 (11.76%)  6 0/17 (0.00%)  0
General disorders     
Infusion site erythema * 1  0/17 (0.00%)  0 3/17 (17.65%)  4
Peripheral swelling * 1  0/17 (0.00%)  0 3/17 (17.65%)  3
Fatigue * 1  3/17 (17.65%)  3 0/17 (0.00%)  0
Pain * 1  2/17 (11.76%)  2 0/17 (0.00%)  0
Infections and infestations     
Urinary tract infection * 1  3/17 (17.65%)  4 0/17 (0.00%)  0
Injury, poisoning and procedural complications     
Fall * 1  2/17 (11.76%)  2 0/17 (0.00%)  0
Investigations     
Bacterial test positive * 1  0/17 (0.00%)  0 2/17 (11.76%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/17 (0.00%)  0 3/17 (17.65%)  3
Nervous system disorders     
Headache * 1  5/17 (29.41%)  10 6/17 (35.29%)  9
Chronic inflammatory demyelinating polyradiculoneuropathy * 1  4/17 (23.53%)  4 4/17 (23.53%)  4
Hypoaesthesia * 1  2/17 (11.76%)  2 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash * 1  2/17 (11.76%)  3 0/17 (0.00%)  0
1
Term from vocabulary, MedDRA v24.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: 001-844-599-2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
ClinicalTrials.gov Identifier: NCT03861481    
Other Study ID Numbers: CIDP01
2016-002411-17 ( EudraCT Number )
First Submitted: March 1, 2019
First Posted: March 4, 2019
Results First Submitted: March 9, 2022
Results First Posted: April 4, 2022
Last Update Posted: May 23, 2022