Trial Outcomes & Findings for ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA (NCT NCT03891875)
NCT ID: NCT03891875
Last Updated: 2024-07-12
Results Overview
Change in low luminance best corrected visual acuity (LL BCVA) score from Baseline to the end of treatment (EOT; Week 48) assessment measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. ETDRS charts present a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows; there is a total of 14 lines (70 letters), with letter size increasing further geometrically and equivalently in every line by a factor of 1.2589 (or 0.1 log unit), moving up the chart. Minimum score of zero, maximum score of 100. Change from baseline: a more negative score is worse outcome, a more positive score is better outcome. A lower score means less letters were read correctly (worse outcome) and a higher score means more letters were read correctly (better outcome).
COMPLETED
PHASE2
176 participants
Baseline and Weeks 4, 8, 12, 24, 36, 48
2024-07-12
Participant Flow
Participant milestones
| Measure |
Elamipretide
40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
Placebo
Daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
59
|
|
Overall Study
COMPLETED
|
83
|
51
|
|
Overall Study
NOT COMPLETED
|
34
|
8
|
Reasons for withdrawal
| Measure |
Elamipretide
40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
Placebo
Daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
20
|
3
|
|
Overall Study
Adverse Event
|
10
|
4
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
COVID-19 infection
|
1
|
0
|
Baseline Characteristics
All individuals for whom body mass index was measured.
Baseline characteristics by cohort
| Measure |
Elamipretide
n=114 Participants
40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
Placebo
n=58 Participants
Daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.0 years
STANDARD_DEVIATION 8.40 • n=114 Participants
|
75.8 years
STANDARD_DEVIATION 8.80 • n=58 Participants
|
76.0 years
STANDARD_DEVIATION 8.51 • n=172 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=114 Participants
|
36 Participants
n=58 Participants
|
104 Participants
n=172 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=114 Participants
|
22 Participants
n=58 Participants
|
68 Participants
n=172 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=114 Participants
|
2 Participants
n=58 Participants
|
4 Participants
n=172 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
111 Participants
n=114 Participants
|
53 Participants
n=58 Participants
|
164 Participants
n=172 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=114 Participants
|
3 Participants
n=58 Participants
|
4 Participants
n=172 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=114 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=172 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=114 Participants
|
1 Participants
n=58 Participants
|
1 Participants
n=172 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=114 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=172 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=114 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=172 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=114 Participants
|
57 Participants
n=58 Participants
|
169 Participants
n=172 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=114 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=172 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=114 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=172 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=114 Participants
|
58 participants
n=58 Participants
|
172 participants
n=172 Participants
|
|
Body Mass Index
|
29.85 kg/m^2
STANDARD_DEVIATION 6.479 • n=111 Participants • All individuals for whom body mass index was measured.
|
27.92 kg/m^2
STANDARD_DEVIATION 5.380 • n=57 Participants • All individuals for whom body mass index was measured.
|
29.20 kg/m^2
STANDARD_DEVIATION 6.181 • n=168 Participants • All individuals for whom body mass index was measured.
|
|
GA Area (mm2) by OCT
|
1.47 mm^2
STANDARD_DEVIATION 0.761 • n=114 Participants
|
1.38 mm^2
STANDARD_DEVIATION 0.682 • n=58 Participants
|
1.44 mm^2
STANDARD_DEVIATION 0.734 • n=172 Participants
|
|
LL BCVA Score
|
53.4 Letters
STANDARD_DEVIATION 16.17 • n=114 Participants
|
58.8 Letters
STANDARD_DEVIATION 10.70 • n=58 Participants
|
55.2 Letters
STANDARD_DEVIATION 14.75 • n=172 Participants
|
|
BCVA Score
|
75.8 Letters
STANDARD_DEVIATION 9.09 • n=114 Participants
|
76.6 Letters
STANDARD_DEVIATION 7.90 • n=58 Participants
|
76.1 Letters
STANDARD_DEVIATION 8.69 • n=172 Participants
|
PRIMARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 24, 36, 48Population: All subjects for which LL BCVA score change from Baseline was measured. All subjects were randomized and received at least one dose of study drug and have baseline and at least one post-baseline value for LL BCVA or GA Area on OCT. There was early study discontinuation for some of the participants and row numbers, including Week 4, reflect this.
Change in low luminance best corrected visual acuity (LL BCVA) score from Baseline to the end of treatment (EOT; Week 48) assessment measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. ETDRS charts present a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows; there is a total of 14 lines (70 letters), with letter size increasing further geometrically and equivalently in every line by a factor of 1.2589 (or 0.1 log unit), moving up the chart. Minimum score of zero, maximum score of 100. Change from baseline: a more negative score is worse outcome, a more positive score is better outcome. A lower score means less letters were read correctly (worse outcome) and a higher score means more letters were read correctly (better outcome).
Outcome measures
| Measure |
Elamipretide
n=114 Participants
40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
Placebo
n=58 Participants
Daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
|---|---|---|
|
LL BCVA Score Change From Baseline
Week 4
|
0.7 Letters
Standard Deviation 6.11
|
-0.6 Letters
Standard Deviation 5.93
|
|
LL BCVA Score Change From Baseline
Week 8
|
1.1 Letters
Standard Deviation 5.64
|
-0.8 Letters
Standard Deviation 7.71
|
|
LL BCVA Score Change From Baseline
Week 12
|
-0.7 Letters
Standard Deviation 9.35
|
-0.9 Letters
Standard Deviation 7.05
|
|
LL BCVA Score Change From Baseline
Week 24
|
-0.9 Letters
Standard Deviation 9.05
|
-0.9 Letters
Standard Deviation 6.80
|
|
LL BCVA Score Change From Baseline
Week 36
|
-0.6 Letters
Standard Deviation 12.21
|
-3.2 Letters
Standard Deviation 9.37
|
|
LL BCVA Score Change From Baseline
Week 48
|
-2.8 Letters
Standard Deviation 11.40
|
-4.6 Letters
Standard Deviation 11.89
|
PRIMARY outcome
Timeframe: Baseline and Weeks 12, 24, 36, 48Population: All subjects for which GA Area Change From Baseline by OCT was measured. All subjects were randomized and received at least one dose of study drug and have baseline and at least one post-baseline value for LL BCVA or GA Area on OCT. There was early study discontinuation for some of the participants and row numbers, including Week 12, reflect this.
Geographic atrophy (GA) area: change from baseline as measured by optical coherence tomography (OCT) from Baseline to the end of treatment (EOT; Week 48)
Outcome measures
| Measure |
Elamipretide
n=111 Participants
40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
Placebo
n=57 Participants
Daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
|---|---|---|
|
GA Area Change From Baseline by OCT
Week 12
|
0.082 mm^2
Standard Deviation 0.0889
|
0.071 mm^2
Standard Deviation 0.0812
|
|
GA Area Change From Baseline by OCT
Week 24
|
0.166 mm^2
Standard Deviation 0.1391
|
0.166 mm^2
Standard Deviation 0.1426
|
|
GA Area Change From Baseline by OCT
Week 36
|
0.245 mm^2
Standard Deviation 0.1680
|
0.228 mm^2
Standard Deviation 0.1977
|
|
GA Area Change From Baseline by OCT
Week 48
|
0.328 mm^2
Standard Deviation 0.2166
|
0.281 mm^2
Standard Deviation 0.2407
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4,12, 36, 48Population: All subjects for which LL RA change from baseline was measured. There was early study discontinuation for some of the participants and row numbers, including Week 4, reflect this.
Low-luminance ready acuity (LL RA) score change from baseline to the EOT (Week 48). Mean Critical Print Size with Low Luminance in Weeks 4, 12, 36, 48 as measured by the Logarithm of the Minimum Angle of Resolution LogMAR chart. Scores range from -0.3 to 1.0, where higher number means worse acuity/worse outcome, a lower number means better acuity/better outcome.
Outcome measures
| Measure |
Elamipretide
n=114 Participants
40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
Placebo
n=58 Participants
Daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
|---|---|---|
|
LL RA Change From Baseline
Week 12
|
-0.008 units on a scale
Standard Deviation 0.3429
|
0.035 units on a scale
Standard Deviation 0.3244
|
|
LL RA Change From Baseline
Week 4
|
-0.005 units on a scale
Standard Deviation 0.2678
|
0.029 units on a scale
Standard Deviation 0.3169
|
|
LL RA Change From Baseline
Week 36
|
0.002 units on a scale
Standard Deviation 0.3776
|
0.073 units on a scale
Standard Deviation 0.2761
|
|
LL RA Change From Baseline
Week 48
|
0.011 units on a scale
Standard Deviation 0.4082
|
0.101 units on a scale
Standard Deviation 0.3069
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 24, 36, 48Population: All subjects for which BCVA change from baseline was measured. There was early study discontinuation for some of the participants and row numbers, including Week 4, reflect this.
Best-corrected visual acuity (BCVA) change from Baseline Change in best corrected visual acuity (BCVA) score from Baseline to the end of treatment (EOT; Week 48) assessment measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. ETDRS charts present a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows; there is a total of 14 lines (70 letters), with letter size increasing further geometrically and equivalently in every line by a factor of 1.2589 (or 0.1 log unit), moving up the chart. Minimum score of zero, maximum score of 100. Change from baseline: a more negative score is worse outcome, a more positive score is better outcome. A lower score means less letters were read correctly (worse outcome) and a higher score means more letters were read correctly (better outcome).
Outcome measures
| Measure |
Elamipretide
n=114 Participants
40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
Placebo
n=58 Participants
Daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
|---|---|---|
|
BCVA Change From Baseline
Week 4
|
0.3 Letters
Standard Deviation 4.03
|
-0.1 Letters
Standard Deviation 4.51
|
|
BCVA Change From Baseline
Week 8
|
0.0 Letters
Standard Deviation 4.88
|
0.9 Letters
Standard Deviation 4.84
|
|
BCVA Change From Baseline
Week 12
|
-0.2 Letters
Standard Deviation 4.46
|
-0.0 Letters
Standard Deviation 6.14
|
|
BCVA Change From Baseline
Week 24
|
-0.2 Letters
Standard Deviation 5.09
|
-0.2 Letters
Standard Deviation 5.00
|
|
BCVA Change From Baseline
Week 36
|
-1.5 Letters
Standard Deviation 5.76
|
-0.8 Letters
Standard Deviation 6.13
|
|
BCVA Change From Baseline
Week 48
|
-3.0 Letters
Standard Deviation 6.90
|
-2.6 Letters
Standard Deviation 7.86
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 36, 48Population: All subjects for which GA area as measured by fundus autofluorescence (FAF) change from baseline was measured. There was early study discontinuation for some of the participants and row numbers, including Week 12, reflect this.
Change from Baseline in Mean Area of Geographic Atrophy (GA) by Fundus Autofluorescence (FAF) at Week 24. Fluorescein angiography (FA) was used to examine the circulation of the retina and choroid using fluorescein dye and a specialized camera to trace the dye. Fundus autofluorescence imaging of the retinal pigment epithelium and neurosensory retina was performed within 14 days of Day 0 and at every visit with the exception of Day 0 and Day 7. Atrophy is characterized by loss of the retinal pigment epithelium (RPE), overlying photoreceptors and underlying choriocapillaris. Greater area affected means a worse outcome than smaller area affected.
Outcome measures
| Measure |
Elamipretide
n=114 Participants
40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
Placebo
n=58 Participants
Daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
|---|---|---|
|
GA Area as Measured by Fundus Autofluorescence (FAF) Change From Baseline
Week 12
|
0.074 mm^2
Standard Deviation 0.0690
|
0.065 mm^2
Standard Deviation 0.0804
|
|
GA Area as Measured by Fundus Autofluorescence (FAF) Change From Baseline
Week 24
|
0.161 mm^2
Standard Deviation 0.1218
|
0.138 mm^2
Standard Deviation 0.1338
|
|
GA Area as Measured by Fundus Autofluorescence (FAF) Change From Baseline
Week 36
|
0.242 mm^2
Standard Deviation 0.1659
|
0.199 mm^2
Standard Deviation 0.1700
|
|
GA Area as Measured by Fundus Autofluorescence (FAF) Change From Baseline
Week 48
|
0.318 mm^2
Standard Deviation 0.2060
|
0.277 mm^2
Standard Deviation 0.2176
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 24 and Week 48Population: All subjects for which Macular Percentage of Ellipsoid Zone (EZ) Total Attenuation was measured. There was early study discontinuation for some of the participants and row numbers, including Week 24, reflect this.
Change from Baseline in Macular Percentage of EZ Total Attenuation by OCT: Week 24 and Week 48 measures photoreceptor loss marked by EZ degradation. Lower increase in percentage means a better outcome. Higher increase in percentage means a worse outcome.
Outcome measures
| Measure |
Elamipretide
n=114 Participants
40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
Placebo
n=58 Participants
Daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
|---|---|---|
|
Macular Percentage of Ellipsoid Zone (EZ) Total Attenuation From Baseline
Week 48
|
3.94 percentage of EZ total attentuation
Standard Deviation 4.052
|
6.38 percentage of EZ total attentuation
Standard Deviation 6.616
|
|
Macular Percentage of Ellipsoid Zone (EZ) Total Attenuation From Baseline
Week 24
|
1.81 percentage of EZ total attentuation
Standard Deviation 3.889
|
2.70 percentage of EZ total attentuation
Standard Deviation 3.291
|
Adverse Events
Elamipretide
Placebo
Serious adverse events
| Measure |
Elamipretide
n=117 participants at risk
40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
Placebo
n=59 participants at risk
Daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
|---|---|---|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Infections and infestations
Corona virus infection
|
1.7%
2/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.7%
2/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Infections and infestations
Pneumonia
|
1.7%
2/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Infections and infestations
Diverticulitis
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Infections and infestations
Abdominal wall abscess
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Cardiac disorders
Angina unstable
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.85%
1/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.85%
1/117 • Up to 54 weeks
|
1.7%
1/59 • Up to 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/117 • Up to 54 weeks
|
1.7%
1/59 • Up to 54 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/117 • Up to 54 weeks
|
1.7%
1/59 • Up to 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/117 • Up to 54 weeks
|
1.7%
1/59 • Up to 54 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/117 • Up to 54 weeks
|
1.7%
1/59 • Up to 54 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/117 • Up to 54 weeks
|
1.7%
1/59 • Up to 54 weeks
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.00%
0/117 • Up to 54 weeks
|
1.7%
1/59 • Up to 54 weeks
|
Other adverse events
| Measure |
Elamipretide
n=117 participants at risk
40 mg daily subcutaneous injection of elamipretide using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
Placebo
n=59 participants at risk
Daily subcutaneous injection of placebo using the elamipretide delivery system for 48 weeks followed by a 4 week follow-up period.
|
|---|---|---|
|
General disorders
Injection Site Erythema
|
18.8%
22/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
General disorders
Injection Site Haemorrhage
|
14.5%
17/117 • Up to 54 weeks
|
6.8%
4/59 • Up to 54 weeks
|
|
General disorders
Injection Site Induration
|
13.7%
16/117 • Up to 54 weeks
|
5.1%
3/59 • Up to 54 weeks
|
|
General disorders
Injection Site Hypertrophy
|
8.5%
10/117 • Up to 54 weeks
|
6.8%
4/59 • Up to 54 weeks
|
|
General disorders
Injection Site Mass
|
11.1%
13/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
General disorders
Injection Site Swelling
|
9.4%
11/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
General disorders
Injection Site Irritation
|
4.3%
5/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
General disorders
Injection Site Urticaria
|
4.3%
5/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
General disorders
Injection Site Discomfort
|
1.7%
2/117 • Up to 54 weeks
|
3.4%
2/59 • Up to 54 weeks
|
|
Eye disorders
Neovascular Age-related Macular Degeneration
|
6.8%
8/117 • Up to 54 weeks
|
8.5%
5/59 • Up to 54 weeks
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/117 • Up to 54 weeks
|
3.4%
2/59 • Up to 54 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
3.4%
4/117 • Up to 54 weeks
|
11.9%
7/59 • Up to 54 weeks
|
|
Infections and infestations
Pneumonia
|
3.4%
4/117 • Up to 54 weeks
|
1.7%
1/59 • Up to 54 weeks
|
|
Infections and infestations
Corona Virus Infection
|
2.6%
3/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
3/117 • Up to 54 weeks
|
3.4%
2/59 • Up to 54 weeks
|
|
General disorders
Injection Site Pruritus
|
39.3%
46/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
General disorders
Injection Site Pain
|
28.2%
33/117 • Up to 54 weeks
|
10.2%
6/59 • Up to 54 weeks
|
|
General disorders
Injection Site Bruising
|
12.8%
15/117 • Up to 54 weeks
|
18.6%
11/59 • Up to 54 weeks
|
|
Nervous system disorders
Headache
|
3.4%
4/117 • Up to 54 weeks
|
3.4%
2/59 • Up to 54 weeks
|
|
Nervous system disorders
Dizziness
|
1.7%
2/117 • Up to 54 weeks
|
3.4%
2/59 • Up to 54 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.7%
2/117 • Up to 54 weeks
|
3.4%
2/59 • Up to 54 weeks
|
|
Investigations
Eosinophil Count Increased
|
6.0%
7/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.85%
1/117 • Up to 54 weeks
|
5.1%
3/59 • Up to 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.85%
1/117 • Up to 54 weeks
|
3.4%
2/59 • Up to 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.85%
1/117 • Up to 54 weeks
|
3.4%
2/59 • Up to 54 weeks
|
|
Vascular disorders
Hypertension
|
4.3%
5/117 • Up to 54 weeks
|
0.00%
0/59 • Up to 54 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.85%
1/117 • Up to 54 weeks
|
3.4%
2/59 • Up to 54 weeks
|
Additional Information
Jim Carr, Pharm.D. Chief Clinical Development Officer
Stealth BioTherapeutics, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60