Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis

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: NCT02465437
Recruitment Status : Active, not recruiting
First Posted : June 8, 2015
Results First Posted : October 2, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diffuse Cutaneous Systemic Sclerosis
Interventions Drug: JBT-101
Drug: Placebo
Drug: Part B Open-Label Extension
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenabasum (JBT-101) 5 mg QD/20 mg BID Lenabasum (JBT-101) 20 mg QD/20 mg BID Lenabasum (JBT-101) 20 mg BID/20 mg BID Placebo
Hide Arm/Group Description Lenabasum 5 mg QAM and placebo QPM on Days 1-28, then lenabasum 20 mg BID on Days 29-84. Lenabasum 20 mg QAM and placebo QPM on Days 1-28, then lenabasum 20 mg BID on Days 29-84. Lenabasum 20 mg BID on Days 1-84. Placebo BID on Days 1-84.
Period Title: Overall Study
Started 9 9 9 15
Completed 8 8 8 14
Not Completed 1 1 1 1
Reason Not Completed
Physician Decision             0             0             1             0
Withdrawal by Subject             1             0             0             1
Adverse Event             0             1             0             0
Arm/Group Title Lenabasum (JBT-101) 5 mg QD/20 mg BID Lenabasum (JBT-101) 20 mg QD/20 mg BID Lenabasum (JBT-101) 20 mg BID/20 mg BID Placebo Total
Hide Arm/Group Description Lenabasum 5 mg QAM and placebo QPM on Days 1-28, then lenabasum 20 mg BID on Days 29-84. Lenabasum 20 mg QAM and placebo QPM on Days 1-28, then lenabasum 20 mg BID on Days 29-84. Lenabasum 20 mg BID on Days 1-84. Placebo BID on Days 1-84. Total of all reporting groups
Overall Number of Baseline Participants 9 9 9 15 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 15 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  88.9%
9
 100.0%
7
  77.8%
15
 100.0%
39
  92.9%
>=65 years
1
  11.1%
0
   0.0%
2
  22.2%
0
   0.0%
3
   7.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 9 participants 15 participants 42 participants
49.7  (10.75) 47.2  (4.63) 49.1  (14.57) 46.5  (11.05) 47.9  (10.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 15 participants 42 participants
Female
9
 100.0%
8
  88.9%
6
  66.7%
9
  60.0%
32
  76.2%
Male
0
   0.0%
1
  11.1%
3
  33.3%
6
  40.0%
10
  23.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 15 participants 42 participants
Hispanic or Latino
1
  11.1%
2
  22.2%
1
  11.1%
1
   6.7%
5
  11.9%
Not Hispanic or Latino
8
  88.9%
7
  77.8%
7
  77.8%
14
  93.3%
36
  85.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
1
   2.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 15 participants 42 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
1
   2.4%
Asian
1
  11.1%
0
   0.0%
0
   0.0%
3
  20.0%
4
   9.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  22.2%
1
  11.1%
0
   0.0%
0
   0.0%
3
   7.1%
White
6
  66.7%
8
  88.9%
8
  88.9%
12
  80.0%
34
  81.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 9 participants 15 participants 42 participants
9
 100.0%
9
 100.0%
9
 100.0%
15
 100.0%
42
 100.0%
Baseline Modified Rodnan Skin Score (mRSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 9 participants 9 participants 9 participants 15 participants 42 participants
21.6  (9.29) 26.7  (12.03) 22.3  (10.16) 26.2  (11.12) 24.5  (10.60)
[1]
Measure Description: The mRSS is an evaluation of patient’s skin thickness by clinical palpation using a 0–3 scale; 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch the skin into a fold for each of 17 surface anatomic areas of the body: face, anterior chest, abdomen, and, with right and left sides of the body separately evaluated, the fingers, forearms, upper arms, thighs, lower legs, dorsum of hands and feet. Individual values are summed and defined as the total skin score. Lowest score of 0 and maximum of 51 with higher scores indicate worse symptomology.
Baseline HAQ-DI   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 9 participants 9 participants 9 participants 15 participants 42 participants
1.07  (0.745) 1.49  (0.697) 0.83  (0.890) 1.51  (0.793) 1.26  (0.809)
[1]
Measure Description: Health Assessment Questionnaire - Disability Index includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are two or three questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The eight scores of the eight sections are summed and divided by 8. If one section is not completed by a subject, the summed score is divided by 7. As such, maximum scores can vary with a min of 0. The result is the DI, the disability index or functional disability index. Higher scores indicate worse symptomology.
Baseline FVC % Predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent predicted
Number Analyzed 9 participants 9 participants 9 participants 14 participants 41 participants
84.15  (9.044) 93.79  (11.740) 80.10  (15.993) 79.61  (10.286) 84.33  (12.185)
[1]
Measure Analysis Population Description: Note: One subject in the Placebo cohort did not have a FVC % predicted measurement conducted, as such, the total number of subjects in the placebo cohort for FVC % predicted is n = 14 and for the total population, n = 41.
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events From Baseline at Day 113
Hide Description The overall number of subjects with TEAE's per treatment group during active dosing (Days 1-84) plus the 28 day follow-up.
Time Frame Part A: Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
Per the statistical analysis plan, the intent was to analyze all subjects receiving lenabasum and compare to those subjects receiving placebo for the primary endpoint. As such, individual lenabasum groups were not reported to follow the pre-specified statistical analysis plan.
Arm/Group Title Placebo Combined Lenabasum Group
Hide Arm/Group Description:
Placebo BID on Days 1-84.
Combination of all lenabasum cohorts for analysis purposes only.
Overall Number of Participants Analyzed 15 27
Measure Type: Count of Participants
Unit of Measure: Participants
9
  60.0%
17
  63.0%
2.Primary Outcome
Title Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Day 85 and 113
Hide Description CRISS components included the following domains: modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index. An algorithm determines the predicted probability of improvement from baseline by incorporating change in the mRSS, FVC percent predicted, Physician and Patient Global Assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 – 100%). A cut-off at 0.6 in the predicted probability of being improved has yielded the smallest misclassification error. Subjects are not considered improved if, between Visit 1 and 6, they develop new: 1) renal crisis; 2) decline in FVC% predicted by 15% (relative) from baseline and confirmed after 1 month; or 3) left ventricular failure (systolic ejection fraction < 45%) or pulmonary artery hypertension. Higher CRISS scores indicates improvement.
Time Frame Day 85 and Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
Per the statistical analysis plan, the intent was to analyze all subjects receiving lenabasum and compare to those subjects receiving placebo for this endpoint. As such, individual lenabasum groups were not reported to follow the pre-specified statistical analysis plan. Only subjects with values at Visit 5 and 6 were included in this analysis.
Arm/Group Title Placebo Combined Lenabasum Group
Hide Arm/Group Description:
Placebo BID on Days 1-84.
Combination of all lenabasum cohorts for analysis purposes only.
Overall Number of Participants Analyzed 15 26
Median (Full Range)
Unit of Measure: units on a scale
CRISS score at Visit 5 (Day 85)
0.010
(0.00 to 1.00)
0.275
(0.00 to 1.00)
CRISS score at Visit 6 (Day 113)
0.00
(0.00 to 1.00)
0.330
(0.00 to 1.00)
3.Secondary Outcome
Title CRISS Individual Components (mRSS Total Score) Change From Baseline.
Hide Description The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for mRSS total score. Change from Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. The mRSS consists of an evaluation of patient's skin thickness rated by clinical palpation using a 0-3 scale (0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch the skin into a fold for each of 17 surface anatomic areas of the body: face, anterior chest, abdomen, and, with right and left sides of the body separately evaluated, the fingers, forearms, upper arms, thighs, lower legs, dorsum of hands and feet. Individual values are summed and defined as the total skin score. Total score is 0 to 51 with higher scores indicating worse symptomology
Time Frame Day 85 and 113
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Lenabasum Cohorts Placebo
Hide Arm/Group Description:
This analysis group combines data from lenabasum Cohort 1 (5 mg QD/20mg BID), Cohort 2 (20 mg QD/20 mg BID), and Cohort 3 (20 mg BID/20 mg BID) for analysis purposes only.
Placebo subjects in this study received placebo for the entire duration of the trial.
Overall Number of Participants Analyzed 27 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
mRSS Total Score CFB at Visit 5 (Day 85) -3.8  (1.1) -2.6  (1.5)
mRSS Total Score CFB at Visit 6 (Day 113) -4.7  (1.1) -2.0  (1.5)
4.Secondary Outcome
Title CRISS Individual Component (FVC Percent Predicted) Change From Baseline
Hide Description The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for FVC percent predicted. Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline.
Time Frame Day 85 and 113
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Lenabasum Cohorts Placebo
Hide Arm/Group Description:
This analysis group combines data from lenabasum Cohort 1 (5 mg QD/20mg BID), Cohort 2 (20 mg QD/20 mg BID), and Cohort 3 (20 mg BID/20 mg BID) for analysis purposes only.
Placebo subjects in this study received placebo for the entire duration of the trial.
Overall Number of Participants Analyzed 27 15
Mean (Standard Deviation)
Unit of Measure: percent predicted
FVC % predicted CFB at Visit 5 (Day 85) 0.90  (0.99) -0.77  (1.32)
FVC % predicted CFB at Visit 6 (Day 113) 0.20  (0.92) -0.98  (1.22)
5.Secondary Outcome
Title CRISS Individual Component (Physician Global Assessment Score) Change From Baseline
Hide Description The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for physician global assessment. Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. The Physician Global Assessment of disease activity will be performed using a segmented numerical version of the visual analogue scale in which the physician selects a whole number (0-10 integers) that best reflects the overall disease activity. The numerical rating score is anchored by 2 verbal descriptors, one of “no disease activity” (score of 0) and one of “worse imaginable disease activity” (score of 10), with numbers 1-9 spaced equidistance in between. The physician will select an integer to describe disease activity. The recall period is one week.
Time Frame Day 85 and 113
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Lenabasum Cohorts Placebo
Hide Arm/Group Description:
This analysis group combines data from lenabasum Cohort 1 (5 mg QD/20mg BID), Cohort 2 (20 mg QD/20 mg BID), and Cohort 3 (20 mg BID/20 mg BID) for analysis purposes only.
Placebo subjects in this study received placebo for the entire duration of the trial.
Overall Number of Participants Analyzed 27 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physician Global Assessment Score CFB at Visit 5 -0.9  (0.3) -0.5  (0.4)
Physician Global Assessment Score CFB at Visit 6 -0.9  (0.3) -0.7  (0.3)
6.Secondary Outcome
Title CRISS Individual Component (Patient Global Assessment Score) Change From Baseline
Hide Description The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for patient global assessment. Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. The assessment at each specified visit will be performed with a segmented numerical version of the visual analogue scale in which the subject selects a whole number (0-10 integers) that best reflects the overall disease activity. The numerical rating score is anchored by two verbal descriptors, one of “no disease activity” (score of 0) and one of “worse imaginable disease activity” (score of 10), with numbers 1-9 spaced equidistance in between. The subject will select an integer to describe disease activity. The recall period is one week.
Time Frame Day 85 and 113
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Lenabasum Cohorts Placebo
Hide Arm/Group Description:
This analysis group combines data from lenabasum Cohort 1 (5 mg QD/20mg BID), Cohort 2 (20 mg QD/20 mg BID), and Cohort 3 (20 mg BID/20 mg BID) for analysis purposes only.
Placebo subjects in this study received placebo for the entire duration of the trial.
Overall Number of Participants Analyzed 27 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Patient Global Assessment Score CFB at Visit 5 -0.8  (0.4) 0.4  (0.6)
Patient Global Assessment Score CFB at Visit 6 -0.9  (0.4) 0.3  (0.5)
7.Secondary Outcome
Title CRISS Individual Component (HAQ-DI Score) Change From Baseline.
Hide Description Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. Health Assessment Questionnaire - Disability Index includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are two or three questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The eight scores of the eight sections are summed and divided by 8. If one section is not completed by a subject, the summed score is divided by 7. As such, maximum scores can vary with a min of 0. The result is the DI, the disability index or functional disability index. Higher scores indicate worse symptomology
Time Frame Day 85 and 113
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combined Lenabasum Cohorts Placebo
Hide Arm/Group Description:
This analysis group combines data from lenabasum Cohort 1 (5 mg QD/20mg BID), Cohort 2 (20 mg QD/20 mg BID), and Cohort 3 (20 mg BID/20 mg BID) for analysis purposes only.
Placebo subjects in this study received placebo for the entire duration of the trial.
Overall Number of Participants Analyzed 27 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
HAQ-DI CFB at Visit 5 (Day 85) -0.22  (0.07) 0.11  (0.10)
HAQ-DI CFB at Visit 6 (Day 113) -0.14  (0.07) 0.11  (0.09)
Time Frame Days 1 - 113
Adverse Event Reporting Description Lenabasum (JBT-101) 5 mg QD/20 mg BID, Lenabasum (JBT-101) 20 mg QD/20 mg BID, and Lenabasum (JBT-101) 20 mg BID/20 mg BID Groups were combined (i.e., Combined Lenabasum) as pre-specified in the study protocol.
 
Arm/Group Title Placebo (Days 1 - 84 + After-treatment Period) Combined Lenabasum (Days 1 - 84 + After-treatment Period)
Hide Arm/Group Description Placebo cohort for the overall study. Combined lenabasum cohorts for the overall study.
All-Cause Mortality
Placebo (Days 1 - 84 + After-treatment Period) Combined Lenabasum (Days 1 - 84 + After-treatment Period)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/27 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Days 1 - 84 + After-treatment Period) Combined Lenabasum (Days 1 - 84 + After-treatment Period)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/15 (6.67%)   1/27 (3.70%) 
Gastrointestinal disorders     
Vomiting *  0/15 (0.00%)  1/27 (3.70%) 
Abdominal pain *  1/15 (6.67%)  0/27 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo (Days 1 - 84 + After-treatment Period) Combined Lenabasum (Days 1 - 84 + After-treatment Period)
Affected / at Risk (%) Affected / at Risk (%)
Total   9/15 (60.00%)   17/27 (62.96%) 
Eye disorders     
Vision blurred *  1/15 (6.67%)  0/27 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper *  0/15 (0.00%)  1/27 (3.70%) 
Constipation *  0/15 (0.00%)  1/27 (3.70%) 
Diarrhoea *  0/15 (0.00%)  2/27 (7.41%) 
Dry mouth *  1/15 (6.67%)  0/27 (0.00%) 
Dyspepsia *  1/15 (6.67%)  0/27 (0.00%) 
Mouth ulceration *  0/15 (0.00%)  1/27 (3.70%) 
Nausea *  2/15 (13.33%)  1/27 (3.70%) 
Stomatitis *  0/15 (0.00%)  1/27 (3.70%) 
General disorders     
Face oedema * [1]  0/15 (0.00%)  1/27 (3.70%) 
Fatigue *  1/15 (6.67%)  5/27 (18.52%) 
Feeling abnormal *  0/15 (0.00%)  1/27 (3.70%) 
Oedema peripheral *  0/15 (0.00%)  1/27 (3.70%) 
Pain *  0/15 (0.00%)  1/27 (3.70%) 
Pyrexia *  0/15 (0.00%)  1/27 (3.70%) 
Infections and infestations     
Herpes simplex *  0/15 (0.00%)  1/27 (3.70%) 
Herpes zoster *  1/15 (6.67%)  0/27 (0.00%) 
Infected skin ulcer *  1/15 (6.67%)  0/27 (0.00%) 
Nasopharyngitis *  0/15 (0.00%)  1/27 (3.70%) 
Oral herpes *  0/15 (0.00%)  1/27 (3.70%) 
Sinusitis *  0/15 (0.00%)  1/27 (3.70%) 
Small intestinal bacterial overgrowth *  1/15 (6.67%)  0/27 (0.00%) 
Upper respiratory tract infection *  0/15 (0.00%)  3/27 (11.11%) 
Urinary tract infection *  1/15 (6.67%)  2/27 (7.41%) 
Injury, poisoning and procedural complications     
Concussion *  1/15 (6.67%)  0/27 (0.00%) 
Post-traumatic pain *  1/15 (6.67%)  0/27 (0.00%) 
Investigations     
Alanine aminotransferase increased *  1/15 (6.67%)  0/27 (0.00%) 
Forced vital capacity decreased *  2/15 (13.33%)  0/27 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia *  1/15 (6.67%)  3/27 (11.11%) 
Back pain *  1/15 (6.67%)  0/27 (0.00%) 
Joint stiffness *  0/15 (0.00%)  1/27 (3.70%) 
Joint swelling *  0/15 (0.00%)  1/27 (3.70%) 
Muscle spasms *  0/15 (0.00%)  1/27 (3.70%) 
Musculoskeletal pain *  0/15 (0.00%)  1/27 (3.70%) 
Pain in extremity *  1/15 (6.67%)  1/27 (3.70%) 
Rheumatoid arthritis *  0/15 (0.00%)  1/27 (3.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Thyroid neoplasm *  0/15 (0.00%)  1/27 (3.70%) 
Nervous system disorders     
Disturbance in attention *  0/15 (0.00%)  1/27 (3.70%) 
Dizziness *  2/15 (13.33%)  6/27 (22.22%) 
Headache *  1/15 (6.67%)  3/27 (11.11%) 
Hypoaesthesia *  0/15 (0.00%)  1/27 (3.70%) 
Nervous system disorder *  0/15 (0.00%)  1/27 (3.70%) 
Paraesthesia *  0/15 (0.00%)  1/27 (3.70%) 
Radiculopathy *  1/15 (6.67%)  0/27 (0.00%) 
Somnolence *  1/15 (6.67%)  0/27 (0.00%) 
Psychiatric disorders     
Anxiety *  0/15 (0.00%)  1/27 (3.70%) 
Bradyphrenia *  0/15 (0.00%)  1/27 (3.70%) 
Dysphoria *  0/15 (0.00%)  1/27 (3.70%) 
Initial insomnia *  0/15 (0.00%)  1/27 (3.70%) 
Insomnia *  1/15 (6.67%)  0/27 (0.00%) 
Paranoia *  0/15 (0.00%)  1/27 (3.70%) 
Restlessness *  1/15 (6.67%)  0/27 (0.00%) 
Renal and urinary disorders     
Dysuria *  0/15 (0.00%)  1/27 (3.70%) 
Skin and subcutaneous tissue disorders     
Pruritus *  0/15 (0.00%)  1/27 (3.70%) 
Pruritus generalized *  1/15 (6.67%)  0/27 (0.00%) 
Rash *  1/15 (6.67%)  0/27 (0.00%) 
Rash pruritic *  0/15 (0.00%)  1/27 (3.70%) 
Skin lesion *  0/15 (0.00%)  1/27 (3.70%) 
Uticaria *  1/15 (6.67%)  0/27 (0.00%) 
Vascular disorders     
Hypotension *  0/15 (0.00%)  1/27 (3.70%) 
Peripheral ischemia *  0/15 (0.00%)  1/27 (3.70%) 
*
Indicates events were collected by non-systematic assessment
[1]
and administration site conditions
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: John Skutnik, MS
Organization: Corbus Pharmaceuticals, Inc.
Phone: 781-562-9853
Responsible Party: Corbus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02465437     History of Changes
Other Study ID Numbers: JBT101-SSc-001
First Submitted: June 4, 2015
First Posted: June 8, 2015
Results First Submitted: March 8, 2018
Results First Posted: October 2, 2018
Last Update Posted: January 29, 2019