Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection (NCT NCT03511066)
NCT ID: NCT03511066
Last Updated: 2022-10-31
Results Overview
Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (\<37.8)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
228 participants
Primary outcome timeframe
Twice a day (Morning and Evening) from Day 1 to Day 8
Results posted on
2022-10-31
Participant Flow
Participant milestones
| Measure |
CT-P27 90 mg/kg
CT-P27 will be administrated once in IV infusion.
CT-P27 90 mg/kg: Influenza A treatment drug.
|
CT-P27 45mg/kg
CT-P27 will be administrated once in IV infusion.
CT-P27 45 mg/kg: Influenza A treatment drug.
|
Placebo
Placebo will be administrated once in IV infusion.
Placebos: Placebo.
|
|---|---|---|---|
|
Overall Study
STARTED
|
88
|
90
|
50
|
|
Overall Study
COMPLETED
|
85
|
85
|
47
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
3
|
Reasons for withdrawal
| Measure |
CT-P27 90 mg/kg
CT-P27 will be administrated once in IV infusion.
CT-P27 90 mg/kg: Influenza A treatment drug.
|
CT-P27 45mg/kg
CT-P27 will be administrated once in IV infusion.
CT-P27 45 mg/kg: Influenza A treatment drug.
|
Placebo
Placebo will be administrated once in IV infusion.
Placebos: Placebo.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection
Baseline characteristics by cohort
| Measure |
CT-P27 90 mg/kg
n=88 Participants
CT-P27 will be administrated once in IV infusion.
CT-P27 90 mg/kg: Influenza A treatment drug.
|
CT-P27 45mg/kg
n=90 Participants
CT-P27 will be administrated once in IV infusion.
CT-P27 45 mg/kg: Influenza A treatment drug.
|
Placebo
n=50 Participants
Placebo will be administrated once in IV infusion.
Placebos: Placebo.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.5 years
n=99 Participants
|
40.0 years
n=107 Participants
|
34.5 years
n=206 Participants
|
38.0 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
112 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
116 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
228 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
88 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
228 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
South Korea
|
88 participants
n=99 Participants
|
90 participants
n=107 Participants
|
50 participants
n=206 Participants
|
228 participants
n=7 Participants
|
|
Positive rapid influenza diagnostic test at screening
|
88 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
227 Participants
n=7 Participants
|
|
Influenza A confirmation
by cell culture or qPCR
|
87 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
221 Participants
n=7 Participants
|
|
Influenza A confirmation
Not detected
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Influenza A subtype
Influenza A/H1
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Influenza A subtype
Influenza A/H3
|
82 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
209 Participants
n=7 Participants
|
|
Influenza A subtype
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Influenza A subtype
Not applicable
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Total influenza symptom score at screening
|
2.08 Averaged for each symptoms' score
n=99 Participants
|
2.05 Averaged for each symptoms' score
n=107 Participants
|
2.12 Averaged for each symptoms' score
n=206 Participants
|
2.08 Averaged for each symptoms' score
n=7 Participants
|
|
Body temperature at screening
|
38.1 °C
STANDARD_DEVIATION 0.74 • n=99 Participants
|
38.3 °C
STANDARD_DEVIATION 0.81 • n=107 Participants
|
38.1 °C
STANDARD_DEVIATION 0.65 • n=206 Participants
|
38.2 °C
STANDARD_DEVIATION 0.75 • n=7 Participants
|
PRIMARY outcome
Timeframe: Twice a day (Morning and Evening) from Day 1 to Day 8Population: The intent-to-treat-infected (ITTI) population defined as all randomized subjects with confirmed influenza A by quantitative polymerase chain reaction (qPCR) or cell culture.
Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (\<37.8)
Outcome measures
| Measure |
CT-P27 90 mg/kg
n=87 Participants
CT-P27 will be administrated once in IV infusion.
CT-P27 90 mg/kg: Influenza A treatment drug.
|
CT-P27 45mg/kg
n=86 Participants
CT-P27 will be administrated once in IV infusion.
CT-P27 45 mg/kg: Influenza A treatment drug.
|
Placebo
n=48 Participants
Placebo will be administrated once in IV infusion.
Placebos: Placebo.
|
|---|---|---|---|
|
Time to Resolution of Influenza Symptoms and Fever
|
3.74 Days
Interval 2.72 to 4.46
|
3.69 Days
Interval 2.81 to 4.25
|
5.72 Days
Interval 3.65 to
The upper limit of 95% CI was not calculated due to insufficient number of participants with events (resolution of influenza symptoms and fever).
|
Adverse Events
CT-P27 90 mg/kg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
CT-P27 45mg/kg
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT-P27 90 mg/kg
n=88 participants at risk
CT-P27 will be administrated once in IV infusion.
CT-P27 90 mg/kg: Influenza A treatment drug.
|
CT-P27 45mg/kg
n=90 participants at risk
CT-P27 will be administrated once in IV infusion.
CT-P27 45 mg/kg: Influenza A treatment drug.
|
Placebo
n=50 participants at risk
Placebo will be administrated once in IV infusion.
Placebos: Placebo.
|
|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/88 • up to Day 110/end-of-study (EOS) visit
|
1.1%
1/90 • up to Day 110/end-of-study (EOS) visit
|
0.00%
0/50 • up to Day 110/end-of-study (EOS) visit
|
|
Infections and infestations
Pneumonia
|
0.00%
0/88 • up to Day 110/end-of-study (EOS) visit
|
2.2%
2/90 • up to Day 110/end-of-study (EOS) visit
|
0.00%
0/50 • up to Day 110/end-of-study (EOS) visit
|
|
Infections and infestations
Pneumonia bacterial
|
1.1%
1/88 • up to Day 110/end-of-study (EOS) visit
|
0.00%
0/90 • up to Day 110/end-of-study (EOS) visit
|
0.00%
0/50 • up to Day 110/end-of-study (EOS) visit
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/88 • up to Day 110/end-of-study (EOS) visit
|
1.1%
1/90 • up to Day 110/end-of-study (EOS) visit
|
0.00%
0/50 • up to Day 110/end-of-study (EOS) visit
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/88 • up to Day 110/end-of-study (EOS) visit
|
1.1%
1/90 • up to Day 110/end-of-study (EOS) visit
|
0.00%
0/50 • up to Day 110/end-of-study (EOS) visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/88 • up to Day 110/end-of-study (EOS) visit
|
0.00%
0/90 • up to Day 110/end-of-study (EOS) visit
|
2.0%
1/50 • up to Day 110/end-of-study (EOS) visit
|
Other adverse events
| Measure |
CT-P27 90 mg/kg
n=88 participants at risk
CT-P27 will be administrated once in IV infusion.
CT-P27 90 mg/kg: Influenza A treatment drug.
|
CT-P27 45mg/kg
n=90 participants at risk
CT-P27 will be administrated once in IV infusion.
CT-P27 45 mg/kg: Influenza A treatment drug.
|
Placebo
n=50 participants at risk
Placebo will be administrated once in IV infusion.
Placebos: Placebo.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
3/88 • up to Day 110/end-of-study (EOS) visit
|
7.8%
7/90 • up to Day 110/end-of-study (EOS) visit
|
4.0%
2/50 • up to Day 110/end-of-study (EOS) visit
|
|
Infections and infestations
Oral herpes
|
0.00%
0/88 • up to Day 110/end-of-study (EOS) visit
|
1.1%
1/90 • up to Day 110/end-of-study (EOS) visit
|
6.0%
3/50 • up to Day 110/end-of-study (EOS) visit
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.7%
5/88 • up to Day 110/end-of-study (EOS) visit
|
2.2%
2/90 • up to Day 110/end-of-study (EOS) visit
|
2.0%
1/50 • up to Day 110/end-of-study (EOS) visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER