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Trial record 2 of 2 for:    CIDP04
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A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

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: NCT04051944
Recruitment Status : Completed
First Posted : August 9, 2019
Results First Posted : November 3, 2022
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Intervention Drug: Rozanolixizumab
Enrollment 21
Recruitment Details The study started to enroll study participants in Aug 2019 and concluded in Nov 2021.
Pre-assignment Details Participant Flow refers to the Enrolled Set. Participants from parent study CIDP01 (NCT03861481) who had completed the Treatment Period without a relapse of chronic inflammatory demyelinating polyradiculoneuropathy were directly enrolled into this study. Newly treated participants are participants treated with placebo in parent study CIDP01 (NCT03861481). Previously treated participants are participants treated with rozanolixizumab in parent study CIDP01 (NCT03861481).
Arm/Group Title Rozanolixizumab (Newly Treated) Rozanolixizumab (Previously Treated)
Hide Arm/Group Description Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76.
Period Title: Overall Study
Started 11 10
Completed 3 6
Not Completed 8 4
Reason Not Completed
Study ending             1             1
Early study termination by participant             1             0
Withdrawal by Subject             2             2
Lack of Efficacy             3             0
Adverse event, non- fatal             1             1
Arm/Group Title Rozanolixizumab (Newly Treated) Rozanolixizumab (Previously Treated) Total
Hide Arm/Group Description Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. Total of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
Baseline Characteristics refers to the Safety Set (SS) which consisted of all enrolled study participants who were administered at least one dose of rozanolixizumab in CIDP04.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  72.7%
6
  60.0%
14
  66.7%
>=65 years
3
  27.3%
4
  40.0%
7
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
59.8  (5.1) 59.1  (15.9) 59.5  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
4
  36.4%
6
  60.0%
10
  47.6%
Male
7
  63.6%
4
  40.0%
11
  52.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Asian
1
   9.1%
0
   0.0%
1
   4.8%
White
8
  72.7%
9
  90.0%
17
  81.0%
Other/Mixed
0
   0.0%
1
  10.0%
1
   4.8%
Missing
2
  18.2%
0
   0.0%
2
   9.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Not Hispanic or Latino
9
  81.8%
10
 100.0%
19
  90.5%
Missing
2
  18.2%
0
   0.0%
2
   9.5%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as any event that was not present prior the first administration of investigational medicinal product (IMP) in CIDP04 study or any unresolved event already present before the first administration of IMP in CIDP04 study that worsened in intensity following exposure to treatment until 8 weeks following the last administration of IMP in CIDP04 study.
Time Frame From Baseline until Follow-Up Visit (up to Week 84)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all enrolled study participants who were administered at least one dose of rozanolixizumab in CIDP04.
Arm/Group Title Rozanolixizumab (Newly Treated) Rozanolixizumab (Previously Treated)
Hide Arm/Group Description:
Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76.
Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76.
Overall Number of Participants Analyzed 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
  90.9%
10
 100.0%
Time Frame From Baseline until Follow-Up Visit (up to Week 84)
Adverse Event Reporting Description A TEAE was defined as any event that was not present prior the first administration of IMP in CIDP04 study or any unresolved event already present before the first administration of IMP in CIDP04 study that worsened in intensity following exposure to treatment until 8 weeks following the last administration of IMP in CIDP04 study.
 
Arm/Group Title Rozanolixizumab (Newly Treated) Rozanolixizumab (Previously Treated)
Hide Arm/Group Description Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76.
All-Cause Mortality
Rozanolixizumab (Newly Treated) Rozanolixizumab (Previously Treated)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
Rozanolixizumab (Newly Treated) Rozanolixizumab (Previously Treated)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/11 (18.18%)      2/10 (20.00%)    
Infections and infestations     
Urinary tract infection * 1  0/11 (0.00%)  0 1/10 (10.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma * 1  1/11 (9.09%)  1 0/10 (0.00%)  0
Nervous system disorders     
Chronic inflammatory demyelinating polyradiculoneuropathy * 1  0/11 (0.00%)  0 1/10 (10.00%)  1
Sensory loss * 1  1/11 (9.09%)  1 0/10 (0.00%)  0
1
Term from vocabulary, MedDRA 24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rozanolixizumab (Newly Treated) Rozanolixizumab (Previously Treated)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/11 (90.91%)      9/10 (90.00%)    
Gastrointestinal disorders     
Diarrhoea * 1  1/11 (9.09%)  2 1/10 (10.00%)  1
Constipation * 1  0/11 (0.00%)  0 2/10 (20.00%)  2
General disorders     
Fatigue * 1  3/11 (27.27%)  3 3/10 (30.00%)  4
Pyrexia * 1  2/11 (18.18%)  2 0/10 (0.00%)  0
Peripheral swelling * 1  1/11 (9.09%)  1 1/10 (10.00%)  1
Infections and infestations     
Influenza * 1  2/11 (18.18%)  2 0/10 (0.00%)  0
Nasopharyngitis * 1  2/11 (18.18%)  2 2/10 (20.00%)  2
Upper respiratory tract infection * 1  2/11 (18.18%)  2 0/10 (0.00%)  0
Urinary tract infection * 1  2/11 (18.18%)  2 0/10 (0.00%)  0
Injury, poisoning and procedural complications     
Muscle strain * 1  1/11 (9.09%)  1 2/10 (20.00%)  2
Fall * 1  0/11 (0.00%)  0 2/10 (20.00%)  4
Investigations     
Blood immunoglobulin G decreased * 1  4/11 (36.36%)  10 4/10 (40.00%)  8
Musculoskeletal and connective tissue disorders     
Joint swelling * 1  1/11 (9.09%)  1 2/10 (20.00%)  2
Muscle spasms * 1  0/11 (0.00%)  0 2/10 (20.00%)  2
Muscular weakness * 1  2/11 (18.18%)  4 0/10 (0.00%)  0
Back pain * 1  1/11 (9.09%)  1 1/10 (10.00%)  1
Nervous system disorders     
Headache * 1  4/11 (36.36%)  7 1/10 (10.00%)  5
Neuralgia * 1  1/11 (9.09%)  1 2/10 (20.00%)  2
Sensory loss * 1  2/11 (18.18%)  3 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Rhinorrhoea * 1  1/11 (9.09%)  1 1/10 (10.00%)  2
Skin and subcutaneous tissue disorders     
Rash * 1  1/11 (9.09%)  1 1/10 (10.00%)  1
1
Term from vocabulary, MedDRA 24.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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 SRL )
ClinicalTrials.gov Identifier: NCT04051944    
Other Study ID Numbers: CIDP04
2018-004392-12 ( EudraCT Number )
First Submitted: August 8, 2019
First Posted: August 9, 2019
Results First Submitted: October 6, 2022
Results First Posted: November 3, 2022
Last Update Posted: November 3, 2022