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Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular Degeneration

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: NCT01367444
Recruitment Status : Terminated (Study stopped not for safety reasons. Due to review of clinical development plans and priorities, Sponsor decided to stop development of the product.)
First Posted : June 7, 2011
Results First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stargardt's Disease
Intervention Drug: SAR422459
Enrollment 27
Recruitment Details The Study was conducted in France and the United States. The trial was ended prematurely and the end of trial date declaration to health authorities was 16-August-2019.
Pre-assignment Details A total of 35 participants who had Stargardt's Macular Degeneration (SMD) were screened, out of which 27 participants were enrolled in 7 cohorts (Cohorts 1 to 7).
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7
Hide Arm/Group Description Participants (aged greater than or equal to [>=] 18 years) with advanced SMD, and visual acuity (VA) less than or equal to (<=) 20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field electroretinography (ERG) responses, received SAR422459 at lowest target dose level 1.8*10^5 transducing units (TU)/study eye. Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye. Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6*10^5 TU/study eye. Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8*10^6 TU/study eye. Participants (aged >=18 years) with SMD, and VA <=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye. Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA >=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye. Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA >=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
Period Title: Overall Study
Started 4 4 4 4 6 4 1
Completed 4 4 4 4 6 4 1
Not Completed 0 0 0 0 0 0 0
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Total
Hide Arm/Group Description Participants (aged >=18 years) with advanced SMD, and VA <=20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye. Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye. Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6*10^5 TU/study eye. Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8*10^6 TU/study eye. Participants (aged >=18 years) with SMD, and VA <=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye. Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA >=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye. Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA >=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye. Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 4 6 4 1 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 4 participants 4 participants 6 participants 4 participants 1 participants 27 participants
55.5
(32 to 66)
40
(30 to 63)
44.5
(35 to 60)
40
(28 to 56)
28
(24 to 41)
23
(21 to 37)
16
(16 to 16)
36
(16 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 6 participants 4 participants 1 participants 27 participants
Female 1 3 4 0 2 2 1 13
Male 3 1 0 4 4 2 0 14
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 6 participants 4 participants 1 participants 27 participants
American Indian or Alaska Native 0 0 0 0 0 0 0 0
Asian 0 0 1 0 0 0 0 1
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0 0
Black or African American 0 0 0 1 0 0 0 1
White 4 4 3 3 6 4 1 25
More than one race 0 0 0 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0 0 0 0
1.Primary Outcome
Title Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) was any unfavorable and unintended physical sign, symptom, or laboratory parameter that developed or worsened in severity during the course of the study, whether or not considered related to the investigational product. The TEAEs were defined as any event that started or increased in severity after the participant received investigational medicinal product (IMP), including abnormal laboratory results, electrocardiogram, etc.
Time Frame From Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants with SMD who were included in the study.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7
Hide Arm/Group Description:
Participants (aged >=18 years) with advanced SMD, and VA <=20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye.
Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye.
Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6*10^5 TU/study eye.
Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8*10^6 TU/study eye.
Participants (aged >=18 years) with SMD, and VA <=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA >=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA >=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
Overall Number of Participants Analyzed 4 4 4 4 6 4 1
Measure Type: Number
Unit of Measure: percentage of participants
100 100 100 100 100 100 100
2.Primary Outcome
Title Percentage of Participants With TEAEs by Severity
Hide Description An AE was any unfavorable and unintended physical sign, symptom, or laboratory parameter that developed or worsened in severity during the course of the study, whether or not considered related to the investigational product. For each AE, the severity was categorized as either mild, moderate or severe where 'mild' was defined as discomfort noticed but did not interfere with the participant's daily routines (an annoyance), 'moderate' was defined as some impairment of function, not hazardous to health (uncomfortable or embarrassing), and 'severe' was defined as significant impairment of function, hazardous to health (incapacitating).
Time Frame From Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants with SMD who were included in the study.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7
Hide Arm/Group Description:
Participants (aged >=18 years) with advanced SMD, and VA <=20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye.
Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye.
Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6*10^5 TU/study eye.
Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8*10^6 TU/study eye.
Participants (aged >=18 years) with SMD, and VA <=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA >=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA >=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
Overall Number of Participants Analyzed 4 4 4 4 6 4 1
Measure Type: Number
Unit of Measure: percentage of participants
Mild 100 100 100 100 100 100 100
Moderate 0 50 25 25 33 75 100
Severe 0 0 0 25 17 25 0
Time Frame All AEs were collected from time of first dose of study drug up to end of study (Week 48) regardless of seriousness or relationship (causality) to IMP.
Adverse Event Reporting Description Reported AEs were TEAEs that developed/worsened during the ‘on treatment period’ (from Day 0 to Week 48). Analysis was performed on all participants with SMD who were included in the study.
 
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7
Hide Arm/Group Description Participants (aged >=18 years) with advanced SMD, and VA <=20/200 in the worst eye and severe cone-rod dysfunction with no detectable or severely abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye. Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at lowest target dose level 1.8*10^5 TU/study eye. Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at escalated target dose level 6*10^5 TU/study eye. Participants (aged >=18 years) with SMD, and VA <=20/200 in the worst eye with abnormal full-field ERG responses, received SAR422459 at target dose level 1.8*10^6 TU/study eye. Participants (aged >=18 years) with SMD, and VA <=20/100 in the worst eye with abnormal full-field ERG responses, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye. Participants (aged 6 to 26 years) with symptomatic early or childhood-onset SMD, and VA >=20/200 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye. Pediatric participants (aged 6 to 17 years) with symptomatic SMD, and VA >=20/100 in both eyes at the time of the screening visit and anticipated to experience rapid deterioration in visual function and/or retinal structure, received SAR422459 at highest target dose level 1.8*10^6 TU/study eye.
All-Cause Mortality
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/6 (0.00%)   0/4 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/6 (0.00%)   1/4 (25.00%)   1/1 (100.00%) 
Eye disorders               
Chorioretinopathy  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Uveitis  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Investigations               
Intraocular pressure increased  1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   4/4 (100.00%)   4/4 (100.00%)   4/4 (100.00%)   6/6 (100.00%)   4/4 (100.00%)   1/1 (100.00%) 
Blood and lymphatic system disorders               
Lymphopenia  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Cardiac disorders               
Ventricular extrasystoles  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Eye disorders               
Anterior chamber cell  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Anterior chamber inflammation  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Cataract  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Chalazion  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Choroidal effusion  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Conjunctival haemorrhage  1  3/4 (75.00%)  2/4 (50.00%)  2/4 (50.00%)  1/4 (25.00%)  3/6 (50.00%)  0/4 (0.00%)  0/1 (0.00%) 
Corneal disorder  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Diplopia  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Dyschromatopsia  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Eye discharge  1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Eye disorder  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Eye inflammation  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Eye irritation  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  2/6 (33.33%)  0/4 (0.00%)  0/1 (0.00%) 
Eye pain  1  2/4 (50.00%)  2/4 (50.00%)  1/4 (25.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  1/1 (100.00%) 
Eye pruritus  1  0/4 (0.00%)  1/4 (25.00%)  2/4 (50.00%)  0/4 (0.00%)  2/6 (33.33%)  0/4 (0.00%)  0/1 (0.00%) 
Eyelid irritation  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Hypotony of eye  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  2/4 (50.00%)  0/1 (0.00%) 
Keratic precipitates  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Macular fibrosis  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  1/4 (25.00%)  0/1 (0.00%) 
Macular oedema  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  2/6 (33.33%)  0/4 (0.00%)  0/1 (0.00%) 
Necrotising retinitis  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Ocular hyperaemia  1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Ocular hypertension  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Photopsia  1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Retinal disorder  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Retinal haemorrhage  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  1/4 (25.00%)  1/6 (16.67%)  2/4 (50.00%)  0/1 (0.00%) 
Retinal tear  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Serous retinal detachment  1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Subretinal fibrosis  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Subretinal fluid  1  1/4 (25.00%)  1/4 (25.00%)  1/4 (25.00%)  0/4 (0.00%)  2/6 (33.33%)  0/4 (0.00%)  0/1 (0.00%) 
Trichiasis  1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Uveitis  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Vision blurred  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Visual impairment  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  1/1 (100.00%) 
Vitreous detachment  1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Vitreous floaters  1  1/4 (25.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  2/6 (33.33%)  0/4 (0.00%)  0/1 (0.00%) 
Vitreous haemorrhage  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Xanthopsia  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders               
Dental caries  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Irritable bowel syndrome  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Nausea  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  1/4 (25.00%)  1/1 (100.00%) 
Vomiting  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
General disorders               
Asthenia  1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Influenza like illness  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Pain  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Infections and infestations               
Conjunctivitis  1  1/4 (25.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Conjunctivitis viral  1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Diarrhoea infectious  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Ear infection  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Nasopharyngitis  1  2/4 (50.00%)  2/4 (50.00%)  1/4 (25.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  1/1 (100.00%) 
Sinusitis  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Injury, poisoning and procedural complications               
Cartilage injury  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Corneal abrasion  1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Tongue injury  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Investigations               
Colour vision tests abnormal  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Fundoscopy abnormal  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Intraocular pressure decreased  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  1/4 (25.00%)  2/6 (33.33%)  0/4 (0.00%)  0/1 (0.00%) 
Intraocular pressure increased  1  2/4 (50.00%)  3/4 (75.00%)  2/4 (50.00%)  1/4 (25.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Monoclonal immunoglobulin present  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Visual field tests abnormal  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders               
Decreased appetite  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Arthritis  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Back pain  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Muscle spasms  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Neck pain  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Osteoarthritis  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Pain in extremity  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Synovial cyst  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Nervous system disorders               
Dizziness  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Headache  1  1/4 (25.00%)  1/4 (25.00%)  0/4 (0.00%)  1/4 (25.00%)  1/6 (16.67%)  2/4 (50.00%)  1/1 (100.00%) 
Tremor  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Visual field defect  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Psychiatric disorders               
Depression  1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Insomnia  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Renal and urinary disorders               
Glycosuria  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Leukocyturia  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Cough  1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Oropharyngeal pain  1  0/4 (0.00%)  1/4 (25.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  1/1 (100.00%) 
Rhinorrhoea  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/4 (0.00%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders               
Dermal cyst  1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
Rash  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Rash erythematous  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/4 (25.00%)  0/1 (0.00%) 
Vascular disorders               
Hypertension  1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/4 (0.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
The planned analysis was adjusted and carried out on the available safety data collected before the Sponsor’s decision to stop SAR422459 development prematurely.
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.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01367444    
Other Study ID Numbers: TDU13583
SG1/001/10
First Submitted: June 3, 2011
First Posted: June 7, 2011
Results First Submitted: May 19, 2020
Results First Posted: June 5, 2020
Last Update Posted: June 5, 2020