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Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 (PRISM2)

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: NCT02317562
Recruitment Status : Terminated (Sponsor's decision)
First Posted : December 16, 2014
Results First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies

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
Intervention Drug: I10E
Enrollment 19
Recruitment Details Between 09 November 2015 and 23 June 2017, 20 subjects from 14 sites signed an informed consent.
Pre-assignment Details 20 subjects signed an informed consent but only 19 subjects enrolled (1 screening failure).
Arm/Group Title I10E Arm
Hide Arm/Group Description

Participation in the study was proposed to all subjects who completed and responded to treatment in PRISM study, satisfying in eligibility criteria and were willing to continue I10E at a reduced maintenance dose.

Each subject was expected to receive 16 doses of I10E (study drug) at 0.5 g/kg over 1 to 2 days, every 3 weeks.

Period Title: Overall Study
Started 19
Completed 5
Not Completed 14
Reason Not Completed
Physician Decision             1
early termination of the study             8
Lack of Efficacy             4
Withdrawal by Subject             1
Arm/Group Title I10E Arm
Hide Arm/Group Description

Participation in the study was proposed to all subjects who completed and responded to treatment in PRISM study, satisfying in eligibility criteria and were willing to continue I10E at a reduced maintenance dose.

Each subject was expected to receive 16 doses of I10E (study drug) at 0.5 g/kg over 1 to 2 days, every 3 weeks.

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
  78.9%
>=65 years
4
  21.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
50.0
(24 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
7
  36.8%
Male
12
  63.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
11
  57.9%
More than one race
0
   0.0%
Unknown or Not Reported
8
  42.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants
Turkey 1
Italy 4
United Kingdom 1
France 2
Tunisia 6
Spain 2
Poland 3
1.Primary Outcome
Title Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit
Hide Description

Since the study was prematurely terminated and an important number of subjects early withdrawn, the responder rate is biased and consequently not interpretable.

Responders were defined as subjects with either:

No change or decrease in the adjusted INCAT disability score and without any change in CIDP treatment between baseline and EOS visit. OR An increase by 1 point in the adjusted INCAT disability score without requirement of any change in CIDP treatment between baseline and EOS visit.

Time Frame week 48 (End-of-Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Study prematurely stopped due to sponsor decision based on the relapse rate.
Arm/Group Title I10E Arm
Hide Arm/Group Description:

Participation in the study was proposed to all subjects who completed and responded to treatment in PRISM study, satisfying in eligibility criteria and were willing to continue I10E at a reduced maintenance dose.

Each subject was expected to receive 16 doses of I10E (study drug) at 0.5 g/kg over 1 to 2 days, every 3 weeks.

Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
15
  78.9%
Time Frame The safety was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study recorded. (up to 48 weeks after inclusion).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title I10E Arm
Hide Arm/Group Description

Participation in the study was proposed to all subjects who completed and responded to treatment in PRISM study, satisfying in eligibility criteria and were willing to continue I10E at a reduced maintenance dose.

Each subject was expected to receive 16 doses of I10E (study drug) at 0.5 g/kg over 1 to 2 days, every 3 weeks.

All-Cause Mortality
I10E Arm
Affected / at Risk (%)
Total   0/19 (0.00%)    
Hide Serious Adverse Events
I10E Arm
Affected / at Risk (%) # Events
Total   1/19 (5.26%)    
Renal and urinary disorders   
Urinary retention * 1  1/19 (5.26%)  1
1
Term from vocabulary, MedDRA (17.1)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
I10E Arm
Affected / at Risk (%) # Events
Total   12/19 (63.16%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/19 (5.26%)  1
Cardiac disorders   
Palpitations * 1  1/19 (5.26%)  1
Ear and labyrinth disorders   
Tinnitus * 1  1/19 (5.26%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/19 (5.26%)  1
Diarrhoea * 1  1/19 (5.26%)  1
Duodenal ulcer * 1  1/19 (5.26%)  1
Gastritis * 1  1/19 (5.26%)  1
Hiatus hernia * 1  1/19 (5.26%)  1
Vomiting * 1  1/19 (5.26%)  1
General disorders   
Fatigue * 1  2/19 (10.53%)  2
Chills * 1  1/19 (5.26%)  1
Injection site erythema * 1  1/19 (5.26%)  1
Injection site oedema * 1  1/19 (5.26%)  1
Pain * 1  1/19 (5.26%)  1
Pyrexia * 1  1/19 (5.26%)  1
Infections and infestations   
Conjunctivitis * 1  1/19 (5.26%)  1
Gastroenteritis viral * 1  1/19 (5.26%)  1
Infected bite * 1  1/19 (5.26%)  1
Influenza * 1  1/19 (5.26%)  2
Nasopharyngitis * 1  1/19 (5.26%)  2
Tooth abscess * 1  1/19 (5.26%)  1
Upper respiratory tract infection * 1  1/19 (5.26%)  1
Urinary tract infection * 1  1/19 (5.26%)  2
Injury, poisoning and procedural complications   
Ligament sprain * 1  1/19 (5.26%)  1
Post traumatic pain * 1  1/19 (5.26%)  1
Investigations   
Blood pressure increased * 1  2/19 (10.53%)  2
Blood lactate dehydrogenase * 1  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Pain in extremity * 1  3/19 (15.79%)  3
Arthralgia * 1  2/19 (10.53%)  3
Back pain * 1  2/19 (10.53%)  2
Neck pain * 1  2/19 (10.53%)  2
Muscle spasms * 1  1/19 (5.26%)  1
Musculoskeletal pain * 1  1/19 (5.26%)  1
Tendonitis * 1  1/19 (5.26%)  1
Nervous system disorders   
Headache * 1  3/19 (15.79%)  5
Migraine * 1  1/19 (5.26%)  2
Neuralgia * 1  1/19 (5.26%)  1
Sciatica * 1  1/19 (5.26%)  1
Psychiatric disorders   
Conversion disorder * 1  1/19 (5.26%)  1
Insomnia * 1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Nasal congestion * 1  1/19 (5.26%)  1
Skin and subcutaneous tissue disorders   
Dry skin * 1  1/19 (5.26%)  1
Eczema nummular * 1  1/19 (5.26%)  1
Erythema * 1  1/19 (5.26%)  3
Rash pruritic * 1  1/19 (5.26%)  1
Vascular disorders   
Hypertension * 1  1/19 (5.26%)  1
Hypotension * 1  1/19 (5.26%)  1
1
Term from vocabulary, MedDRA (17.1)
*
Indicates events were collected by non-systematic assessment

This study was prematurely stopped because 4 subjects relapsed among 14 enrolled and treated subjects at the time of the early assessment of study results.

LFB BIOTECHNOLOGIES judged that it was not acceptable to continue the study.

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: Clinical Information Desk
Organization: LFB
Phone: 0033169827010
EMail: supportqcm@lfb.fr
Layout table for additonal information
Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT02317562    
Other Study ID Numbers: I10E-1306
First Submitted: December 11, 2014
First Posted: December 16, 2014
Results First Submitted: January 5, 2021
Results First Posted: April 20, 2021
Last Update Posted: April 20, 2021