Influenza APhase 2NCT03511066

A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection

A Phase 2 study testing CT-P27 90 mg/kg and CT-P27 45 mg/kg in people with Influenza A, run by Celltrion at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection. Read more about this study

Who is it for?: Ages 19 to 64 years
Conditions the study is for: Influenza A
What is being tested?: CT-P27 90 mg/kg and CT-P27 45 mg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 228 participants
Where: 1 siteSouth Korea
Study dates: 9 Dec 2016to 15 Jun 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or Female subjects between the ages of 19 and 64 years, both inclusive
Diagnosed with influenza A at screening using rapid influenza diagnostic test
Onset of influenza symptoms and fever is within 48 hours at screening
At least 2 of symptoms (moderate to severe in intensity)
≥38.0'C body temperature at screening

Who cannot join

Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug
Positive influenza B or A+B infection

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Korea University Guro Hospital
Seoul, 08308

Other trials in South Korea

About this study

Official title: A Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled Study Evaluating the Efficacy and Safety of CT-P27 in Subjects With Acute Uncomplicated Influenza A Infection

This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection.

Read the detailed description

This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study. All enrolled subjects will be given a single dose of 90 mg/kg CT-P27, 45 mg/kg CT-P27, or placebo intravenously over 90 minutes (±15 minutes) on Day 1 and then followed by Day 110.

Conditions: Influenza A
Being tested: CT-P27 90 mg/kg, CT-P27 45 mg/kg, Placebo
Keywords: efficacy, safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-P27 90 mg/kgDrug
Also called CT-P27
Influenza A treatment drug.
CT-P27 45 mg/kgDrug
Also called CT-P27
Influenza A treatment drug.
PlaceboDrug
Placebo.

Study groups in NCT03511066
Study group	Role	What they receive
CT-P27 90 mg/kg	Experimental	CT-P27 will be administrated once in IV infusion. Receives: Drug: CT-P27 90 mg/kg
CT-P27 45mg/kg	Experimental	CT-P27 will be administrated once in IV infusion. Receives: Drug: CT-P27 45 mg/kg
Placebo	Placebo comparator	Placebo will be administrated once in IV infusion. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Resolution of Influenza Symptoms and Fever
Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (<37.8)
Measured: Twice a day (Morning and Evening) from Day 1 to Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 201615 Jun 2018

First posted27 Apr 2018
Study start9 Dec 2016
Primary completion9 Mar 2018
Study completion15 Jun 2018

Why it stopped: CT-P27 2.2 is inactivated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Influenza AStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03511066
Sponsor's protocol ID: CT-P27 2.2
Status last verified: Aug 2022
First submitted: 28 Feb 2018
Last updated: 31 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Influenza A trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled Study Evaluating the Efficacy and Safety of CT-P27 in Subjects With Acute Uncomplicated Influenza A Infection
ClinicalTrials.gov ID: NCT03511066
Acronym / sponsor ID: CT-P27 2.2
Conditions: Influenza A
Keywords: efficacy, safety
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: CT-P27 2.2 is inactivated
Enrolment: 228 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 9 Dec 2016 (actual)
Primary completion: 9 Mar 2018 (actual)
Study completion: 15 Jun 2018 (actual)
First posted: 27 Apr 2018 (actual)
Results: Posted 31 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
CT-P27 90 mg/kg	Experimental	Drug: CT-P27 90 mg/kgCT-P27 will be administrated once in IV infusion.
CT-P27 45mg/kg	Experimental	Drug: CT-P27 45 mg/kgCT-P27 will be administrated once in IV infusion.
Placebo	Placebo comparator	Drug: PlaceboPlacebo will be administrated once in IV infusion.

Who may qualify

Ages: 19 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male or Female subjects between the ages of 19 and 64 years, both inclusive
Diagnosed with influenza A at screening using rapid influenza diagnostic test
Onset of influenza symptoms and fever is within 48 hours at screening
At least 2 of symptoms (moderate to severe in intensity)
≥38.0'C body temperature at screening

Key exclusion criteria (2 listed)

Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug
Positive influenza B or A+B infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-P27 90 mg/kgAlso: CT-P27Influenza A treatment drug.	Drug	CT-P27 90 mg/kg
CT-P27 45 mg/kgAlso: CT-P27Influenza A treatment drug.	Drug	CT-P27 45mg/kg
PlaceboPlacebo.	Drug	Placebo

Primary outcome

Time to Resolution of Influenza Symptoms and Fever
Time frame: Twice a day (Morning and Evening) from Day 1 to Day 8
Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (<37.8)

Results and safety

Results posted to the registry on 31 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT-P27 90 mg/kg	88	85
CT-P27 45mg/kg	90	85
Placebo	50	47

Primary outcome: Time to Resolution of Influenza Symptoms and Fever

Time frame: Twice a day (Morning and Evening) from Day 1 to Day 8. Median (95% Confidence Interval). Unit: Days

Measure	CT-P27 90 mg/kg n = 87	CT-P27 45mg/kg n = 86	Placebo n = 48
Value	3.74 (2.72 to 4.46)	3.69 (2.81 to 4.25)	5.72 (3.65 to NA)

Population analysed: 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.

Adverse events

Time frame: up to Day 110/end-of-study (EOS) visit. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT-P27 90 mg/kg	1 of 88 (1.1%)	8 of 88 (9.1%)	0 of 88
CT-P27 45mg/kg	5 of 90 (5.6%)	8 of 90 (8.9%)	0 of 90
Placebo	1 of 50 (2%)	6 of 50 (12%)	0 of 50

Limitations and caveats (from the sponsor): All death, 'treatment-emergent' serious adverse events and 'treatment-emergent' adverse events were summarized.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Influenza A

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A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
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RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
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Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MoonSun Choi study director

Celltrion Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CT-P27 90 mg/kg and CT-P27 45 mg/kg in people with Influenza A, run by Celltrion at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Resolution of Influenza Symptoms and Fever (time frame: Twice a day (Morning and Evening) from Day 1 to Day 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03511066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.