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A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus (LUPUZOR)

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ClinicalTrials.gov Identifier: NCT02504645
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
ImmuPharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lupus Erythematosus, Systemic
Interventions Drug: IPP-201101
Drug: Placebo
Other: Standard of Care
Enrollment 202
Recruitment Details  
Pre-assignment Details 200 patients were planned to be enrolled and treated. At the end, 202 were treated.
Arm/Group Title IPP-201101 200-mcg Plus SOC PLACEBO Plus SOC
Hide Arm/Group Description

Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).

IPP-201101

Standard of Care

Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).

Placebo

Standard of Care

Period Title: Overall Study
Started 101 101
Completed 77 76
Not Completed 24 25
Arm/Group Title IPP-201101 200-mcg Plus SOC PLACEBO Plus SOC Total
Hide Arm/Group Description

Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).

IPP-201101

Standard of Care

Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).

Placebo

Standard of Care

Total of all reporting groups
Overall Number of Baseline Participants 101 101 202
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 101 participants 202 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
101
 100.0%
101
 100.0%
202
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 101 participants 202 participants
Female
96
  95.0%
92
  91.1%
188
  93.1%
Male
5
   5.0%
9
   8.9%
14
   6.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 101 participants 202 participants
Not Hispanic or Latino
88
  87.1%
84
  83.2%
172
  85.1%
Hispanic or Latino
13
  12.9%
19
  18.8%
32
  15.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 101 participants 202 participants
Hungary
9
   8.9%
15
  14.9%
24
  11.9%
United States
36
  35.6%
37
  36.6%
73
  36.1%
Czechia
10
   9.9%
5
   5.0%
15
   7.4%
Poland
12
  11.9%
20
  19.8%
32
  15.8%
France
3
   3.0%
4
   4.0%
7
   3.5%
Mauritius
27
  26.7%
22
  21.8%
49
  24.3%
Germany
3
   3.0%
1
   1.0%
4
   2.0%
1.Primary Outcome
Title Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52
Hide Description

A Systemic lupus erythematosus Responder Index (SRI) response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of at least 4 points, no worsening in Physician’s Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new British Isles Lupus Assessment Group A (BILAG A) body system score, and no more than 1 new BILAG B body system score from baseline.

The decrease of 4 points of the SRI is considered as better ouctome.

Time Frame At week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one study drug.
Arm/Group Title IPP-201101 200-mcg Plus SOC PLACEBO Plus SOC
Hide Arm/Group Description:

Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).

IPP-201101

Standard of Care

Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).

Placebo

Standard of Care

Overall Number of Participants Analyzed 101 101
Measure Type: Number
Unit of Measure: percentage of patient responder
52.5 44.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IPP-201101 200-mcg Plus SOC, PLACEBO Plus SOC
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2631
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Post-Hoc Outcome
Title Proportion of Responders of EU Patients Having Anti-dsDNA ar Randomization
Hide Description EU patients who had an assessment of “Yes” for anti-dsDNA at randomization and responders at week 52
Time Frame At week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All EU patients who had an assessment of “Yes” for anti-dsDNA at randomization
Arm/Group Title IPP-201101 200-mcg Plus SOC PLACEBO Plus SOC
Hide Arm/Group Description:

Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).

IPP-201101

Standard of Care

Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).

Placebo

Standard of Care

Overall Number of Participants Analyzed 52 55
Measure Type: Number
Unit of Measure: percentage of patient responder
61.5 47.3
Time Frame Adverse event collection was done during 52 weeks for each patient.
Adverse Event Reporting Description The definitions met the clinicaltrials.gov definitions
 
Arm/Group Title IPP-201101 200-mcg Plus SOC PLACEBO Plus SOC
Hide Arm/Group Description

Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).

IPP-201101

Standard of Care

Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).

Placebo

Standard of Care

All-Cause Mortality
IPP-201101 200-mcg Plus SOC PLACEBO Plus SOC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)   0/101 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
IPP-201101 200-mcg Plus SOC PLACEBO Plus SOC
Affected / at Risk (%) Affected / at Risk (%)
Total   13/101 (12.87%)   16/101 (15.84%) 
Blood and lymphatic system disorders     
Anemia  1  2/101 (1.98%)  1/101 (0.99%) 
Thrombocytopenia  1  0/101 (0.00%)  1/101 (0.99%) 
Cardiac disorders     
Acute myocardial infarction  1  1/101 (0.99%)  0/101 (0.00%) 
Myocarditis  1  1/101 (0.99%)  0/101 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/101 (0.00%)  1/101 (0.99%) 
Colitis  1  0/101 (0.00%)  1/101 (0.99%) 
Nausea  1  0/101 (0.00%)  1/101 (0.99%) 
General disorders     
face Edema  1  1/101 (0.99%)  0/101 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/101 (0.99%)  0/101 (0.00%) 
Infections and infestations     
gastroenteritis  1  1/101 (0.99%)  0/101 (0.00%) 
Gastroenteritis salmonella  1  0/101 (0.00%)  1/101 (0.99%) 
Kidney infection  1  1/101 (0.99%)  0/101 (0.00%) 
Lower respiratory Tract Infection  1  1/101 (0.99%)  0/101 (0.00%) 
Pneumonia  1  0/101 (0.00%)  1/101 (0.99%) 
Injury, poisoning and procedural complications     
Subdural Hematoma  1  0/101 (0.00%)  1/101 (0.99%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/101 (0.99%)  0/101 (0.00%) 
Osteonecrosis  1  0/101 (0.00%)  1/101 (0.99%) 
Systemic lupus erythematosus  1  1/101 (0.99%)  2/101 (1.98%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Mesothelioma malignant  1  1/101 (0.99%)  0/101 (0.00%) 
Uterine leiomyoma  1  1/101 (0.99%)  0/101 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  1/101 (0.99%)  0/101 (0.00%) 
Hypoesthesia  1  1/101 (0.99%)  0/101 (0.00%) 
Migraine  1  1/101 (0.99%)  0/101 (0.00%) 
Syncope  1  0/101 (0.00%)  1/101 (0.99%) 
Tension Headache  1  0/101 (0.00%)  1/101 (0.99%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  1/101 (0.99%)  3/101 (2.97%) 
Psychiatric disorders     
depression  1  0/101 (0.00%)  1/101 (0.99%) 
Renal and urinary disorders     
Acute kidney injury  1  0/101 (0.00%)  1/101 (0.99%) 
Hematuria  1  0/101 (0.00%)  1/101 (0.99%) 
Proteinuria  1  0/101 (0.00%)  1/101 (0.99%) 
Renal failure  1  1/101 (0.99%)  0/101 (0.00%) 
Reproductive system and breast disorders     
Pelvic fluid collection  1  1/101 (0.99%)  0/101 (0.00%) 
uterine hemorrhage  1  1/101 (0.99%)  0/101 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  1/101 (0.99%)  0/101 (0.00%) 
Skin and subcutaneous tissue disorders     
Butterfly rash  1  1/101 (0.99%)  0/101 (0.00%) 
Cutaneous lupus erythematosus  1  0/101 (0.00%)  1/101 (0.99%) 
Vascular disorders     
Deep vein thrombosis  1  0/101 (0.00%)  1/101 (0.99%) 
Hypertension  1  0/101 (0.00%)  2/101 (1.98%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IPP-201101 200-mcg Plus SOC PLACEBO Plus SOC
Affected / at Risk (%) Affected / at Risk (%)
Total   94/101 (93.07%)   96/101 (95.05%) 
Ear and labyrinth disorders     
Vertigo  1  6/101 (5.94%)  7/101 (6.93%) 
Gastrointestinal disorders     
Nausea  1  6/101 (5.94%)  2/101 (1.98%) 
General disorders     
Injection site erythema  1  5/101 (4.95%)  0/101 (0.00%) 
Mucosal ulceration  1  4/101 (3.96%)  8/101 (7.92%) 
Pyrexia  1  5/101 (4.95%)  5/101 (4.95%) 
Infections and infestations     
Bronchitis  1  7/101 (6.93%)  8/101 (7.92%) 
Nasopharyngitis  1  8/101 (7.92%)  7/101 (6.93%) 
Pharyngitis  1  2/101 (1.98%)  5/101 (4.95%) 
Upper respiratory tract infection  1  20/101 (19.80%)  28/101 (27.72%) 
Urinary tract infection  1  23/101 (22.77%)  10/101 (9.90%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  12/101 (11.88%)  13/101 (12.87%) 
Arthritis  1  15/101 (14.85%)  14/101 (13.86%) 
Back pain  1  9/101 (8.91%)  9/101 (8.91%) 
Myalgia  1  6/101 (5.94%)  1/101 (0.99%) 
Systemic lupus erythematosus  1  2/101 (1.98%)  10/101 (9.90%) 
Nervous system disorders     
Headache  1  12/101 (11.88%)  17/101 (16.83%) 
Migraine  1  5/101 (4.95%)  1/101 (0.99%) 
Renal and urinary disorders     
proteinuria  1  3/101 (2.97%)  6/101 (5.94%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/101 (2.97%)  6/101 (5.94%) 
Leukopenia  1  8/101 (7.92%)  7/101 (6.93%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  12/101 (11.88%)  13/101 (12.87%) 
Rash  1  12/101 (11.88%)  8/101 (7.92%) 
Vascular disorders     
Hypertension  1  3/101 (2.97%)  7/101 (6.93%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by 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
Name/Title: CEO
Organization: ImmuPharma
Phone: +33 6 18 22 16 50
Responsible Party: ImmuPharma
ClinicalTrials.gov Identifier: NCT02504645     History of Changes
Other Study ID Numbers: IPP-201101/005
First Submitted: July 17, 2015
First Posted: July 22, 2015
Results First Submitted: February 12, 2019
Results First Posted: April 11, 2019
Last Update Posted: April 11, 2019