Trial Outcomes & Findings for Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD (NCT NCT02461771)
NCT ID: NCT02461771
Last Updated: 2020-10-06
Results Overview
Safety was assessed throughout the study. A TEAE was defined as any AE that started on/after the IVT injection of pegcetacoplan.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Day 1 to Day 113
Results posted on
2020-10-06
Participant Flow
Male and female subjects aged at least 50 years with the presence of an active choroidal neovascular lesion secondary to age-related macular degeneration were recruited to this Phase 1 open-label, single-dose escalation study at 4 study centers in the United States and Australia.
Subjects had received at least 3 anti-vascular endothelial growth factor treatments over the 26 week period prior to screening, and were enrolled into 1 of 3 cohorts to receive pegcetacoplan (previously known as APL-2). If both eyes were eligible for the study, the subject and Principal Investigator chose the eye that served as the study eye.
Participant milestones
| Measure |
Cohort 1
4 milligrams (mg) pegcetacoplan: Subjects received a single intravitreal (IVT) injection of pegcetacoplan (100 microliters \[μL\] of 40 mg per milliliter \[mg/mL\]) on Day 1.
|
Cohort 2
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
7
|
|
Overall Study
COMPLETED
|
3
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
|
Cohort 2
n=3 Participants
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
n=7 Participants
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
79 years
n=7 Participants
|
72 years
n=5 Participants
|
73 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 113Population: The safety set included all subjects who received any amount of study drug.
Safety was assessed throughout the study. A TEAE was defined as any AE that started on/after the IVT injection of pegcetacoplan.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
|
Cohort 2
n=3 Participants
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
n=7 Participants
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
|---|---|---|---|
|
Number of Subjects Who Experienced Ocular and Systemic Adverse Events (AEs), Including by Severity
All TEAEs
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects Who Experienced Ocular and Systemic Adverse Events (AEs), Including by Severity
Ocular TEAEs
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Who Experienced Ocular and Systemic Adverse Events (AEs), Including by Severity
Treatment-related AEs
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Who Experienced Ocular and Systemic Adverse Events (AEs), Including by Severity
Serious AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Who Experienced Ocular and Systemic Adverse Events (AEs), Including by Severity
TEAEs leading to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: The safety set included all subjects who received any amount of study drug.
The occurrence of any of the following AEs were considered DLTs: intraocular inflammation (vitritis or uveitis), endophthalmitis, sustained elevation of intraocular pressure ≥30 millimeters (mm) of mercury, and/or sustained loss of visual acuity ≥15 letters not attributable to the injection procedure or progression of disease.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
|
Cohort 2
n=3 Participants
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
n=7 Participants
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
|---|---|---|---|
|
Number of Dose Limiting Toxicities (DLTs)
|
0 Number of DLTs
|
0 Number of DLTs
|
0 Number of DLTs
|
PRIMARY outcome
Timeframe: Predose (screening), postdose Day 3 to Day 113Population: The pharmacokinetic (PK) set included all subjects in the safety set who had at least one postdose PK sample drawn with a measurable serum concentration of the study drug (even if the concentration was \< lower limit of quantification).
The AUC(0-t) was measured using the linear trapezoidal method when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing. The median AUC(0-t) is presented for each cohort.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
|
Cohort 2
n=3 Participants
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
n=7 Participants
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
|---|---|---|---|
|
Median Area Under the Serum Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-t])
|
11.89 micrograms*day/milliliter (μg*day/mL)
Interval 11.49 to 13.9
|
29.95 micrograms*day/milliliter (μg*day/mL)
Interval 24.27 to 53.59
|
69.53 micrograms*day/milliliter (μg*day/mL)
Interval 55.06 to 86.92
|
PRIMARY outcome
Timeframe: Predose (screening), postdose Day 3 to Day 113Population: The PK set included all subjects in the safety set who had at least one postdose PK sample drawn with a measurable serum concentration of the study drug (even if the concentration was \< lower limit of quantification).
The AUC(0-t) was measured using the linear trapezoidal method when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing. The dose normalized AUC(0-t) was calculated for each subject by dividing the parameter by the subject's respective dose in milligrams. The median dose normalized AUC(0-t) is presented for each cohort.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
|
Cohort 2
n=3 Participants
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
n=7 Participants
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
|---|---|---|---|
|
Median Dose Normalized AUC(0-t)
|
2.97 (μg*day/mL)/respective mg dose
Interval 2.87 to 3.47
|
3.00 (μg*day/mL)/respective mg dose
Interval 2.43 to 5.36
|
3.48 (μg*day/mL)/respective mg dose
Interval 2.75 to 4.35
|
PRIMARY outcome
Timeframe: Predose (screening), postdose Day 3 to Day 113Population: The PK set included all subjects in the safety set who had at least one postdose PK sample drawn with a measurable serum concentration of the study drug (even if the concentration was \< lower limit of quantification).
The median Cmax is presented for each cohort.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
|
Cohort 2
n=3 Participants
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
n=7 Participants
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
|
0.383 μg/mL
Interval 0.317 to 0.387
|
0.764 μg/mL
Interval 0.596 to 1.61
|
2.140 μg/mL
Interval 1.44 to 3.97
|
PRIMARY outcome
Timeframe: Predose (screening), postdose Day 3 to Day 113Population: The PK set included all subjects in the safety set who had at least one postdose PK sample drawn with a measurable serum concentration of the study drug (even if the concentration was \< lower limit of quantification).
The dose normalized Cmax was calculated for each subject by dividing the parameter by the subject's respective dose in milligrams. The median dose normalized Cmax is presented for each cohort.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
|
Cohort 2
n=3 Participants
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
n=7 Participants
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
|---|---|---|---|
|
Median Dose Normalized Cmax
|
0.096 (μg/mL)/respective mg dose
Interval 0.079 to 0.097
|
0.076 (μg/mL)/respective mg dose
Interval 0.06 to 0.161
|
0.107 (μg/mL)/respective mg dose
Interval 0.072 to 0.199
|
PRIMARY outcome
Timeframe: Predose (screening), postdose Day 3 to Day 113Population: The PK set included all subjects in the safety set who had at least one postdose PK sample drawn with a measurable serum concentration of the study drug (even if the concentration was \< lower limit of quantification).
The median Tmax is presented for each cohort. If the maximum value occurred at more than 1 time point, Tmax was defined as the first time point with this value.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
|
Cohort 2
n=3 Participants
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
n=7 Participants
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
|---|---|---|---|
|
Median Time to the Maximum Measured Serum Concentration (Tmax)
|
14.0 day
Interval 8.9 to 14.9
|
7.9 day
Interval 7.0 to 14.9
|
15.0 day
Interval 6.9 to 16.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 113Population: The efficacy set included all subjects who received any amount of the study drug.
Best Corrected Visual Acuity (BCVA) letter score was determined using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. The score ranges from 0 to 100 letters, lower number indicating reduced visual acuity; a positive value of change from baseline indicates visual acuity gain and a negative value indicates visual acuity loss.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
|
Cohort 2
n=3 Participants
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
n=7 Participants
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
|---|---|---|---|
|
Median Change From Baseline in Visual Acuity for the Study Eye
|
1 letters read correctly
Interval 0.0 to 4.0
|
3 letters read correctly
Interval -9.0 to 11.0
|
-1 letters read correctly
Interval -4.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 113Population: The safety set included all subjects who received any amount of study drug.
Central retinal thickness, central retinal lesion thickness and central subfield thickness were determined using Spectral Domain Optical Coherence Tomography (SD-OCT).
Outcome measures
| Measure |
Cohort 1
n=3 Participants
4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
|
Cohort 2
n=3 Participants
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
n=7 Participants
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
|---|---|---|---|
|
Median Change From Baseline in Central Retinal Thickness, Central Retinal Lesion Thickness and Central Subfield Thickness in the Study Eye
Retinal lesion thickness
|
-79.5 micrometers
Interval -128.0 to 64.0
|
2.5 micrometers
Interval -104.0 to 31.5
|
19.0 micrometers
Interval -21.5 to 212.0
|
|
Median Change From Baseline in Central Retinal Thickness, Central Retinal Lesion Thickness and Central Subfield Thickness in the Study Eye
Retinal thickness
|
-106 micrometers
Interval -129.0 to 71.5
|
5.0 micrometers
Interval -109.0 to 22.0
|
37.5 micrometers
Interval -9.5 to 170.5
|
|
Median Change From Baseline in Central Retinal Thickness, Central Retinal Lesion Thickness and Central Subfield Thickness in the Study Eye
Central Subfield Thickness
|
-29.0 micrometers
Interval -48.0 to 42.0
|
-12.0 micrometers
Interval -80.0 to 20.0
|
65.0 micrometers
Interval -11.0 to 138.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 113Population: The safety set included all subjects who received any amount of study drug.
Macular cube volume was determined using SD-OCT.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
|
Cohort 2
n=3 Participants
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
n=7 Participants
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
|---|---|---|---|
|
Median Change From Baseline in Macular Cube Volume in the Study Eye
|
-0.4 mm^3
Interval -2.1 to 0.2
|
-0.1 mm^3
Interval -0.3 to 0.2
|
0.3 mm^3
Interval -0.3 to 0.7
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
4 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 40 mg/mL) on Day 1.
|
Cohort 2
n=3 participants at risk
10 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 100 mg/mL) on Day 1.
|
Cohort 3
n=7 participants at risk
20 mg pegcetacoplan: Subjects received a single IVT injection of pegcetacoplan (100 μL of 200 mg/mL) on Day 1.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
33.3%
1/3 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/7 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
|
Eye disorders
Eye pain
|
33.3%
1/3 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
28.6%
2/7 • Number of events 2 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
14.3%
1/7 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
33.3%
1/3 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/7 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
14.3%
1/7 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
14.3%
1/7 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
33.3%
1/3 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/7 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
14.3%
1/7 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
14.3%
1/7 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
14.3%
1/7 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
14.3%
1/7 • Number of events 2 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/3 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
33.3%
1/3 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/7 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
33.3%
1/3 • Number of events 1 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
0.00%
0/7 • TEAEs were collected from Day 1 up to the final study visit at Day 113 (approximately 16 weeks).
The safety set included all subjects who received any amount of study drug.
|
Additional Information
Apellis Clinical Trial Information Line
Apellis Pharmaceuticals, Inc
Phone: 1-833-284-6361
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place