Study of an Investigational Monoclonal Antibody, VIS410, in Subjects With Uncomplicated Influenza A

NCT02989194 | Completed Phase 2 Results DMC

• 1 other identifier: VIS410-202
• Study Type: interventional
• Target: 150
• Locations: 7 countries
• Sites: 54

Brief Summary

This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the safety and tolerability of an investigational monoclonal antibody, VIS410, in subjects with uncomplicated influenza.

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection

  The percentage of participants with adverse events (AEs) and serious adverse events (SAEs) following administration of a single dose of IV VIS410.

  100 days

• Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest

  Percentage of participants experiencing any TEAE, TEAEs considered related to study treatment and the number of participants experiencing adverse events of special interest (AESI). A TEAE is defined as an adverse event that starts on or after the date of study drug IV infusion. AESIs included hypersensitivity reaction, anaphylactic reaction, or injection site adverse event.

  100 days

Secondary Outcomes (16)

• Percentage Change From Baseline in Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410

  10 days

• Hospitalization for Influenza-related Complications

  100 days

• Duration of Hospitalization for Complications of Influenza

  100 days

• Count of Participants With Complications of Influenza

  100 days

• Influenza A Relapse/Reinfection

  100 days

Study Arms (3)

VIS410 low dose

EXPERIMENTAL

Single intravenous fixed low dose of VIS410

Drug: VIS410 low dose

VIS410 high dose

EXPERIMENTAL

Single intravenous fixed high dose of VIS410

Drug: VIS410 high dose

Placebo

PLACEBO COMPARATOR

Single intravenous placebo infusion

Drug: Placebo

Interventions

VIS410 low dose DRUG

Single intravenous fixed low dose of VIS410

VIS410 low dose

VIS410 high dose DRUG

Single intravenous fixed high dose of VIS410

VIS410 high dose

Placebo DRUG

Single intravenous infusion of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged ≥18 years and ˂65 years
• Women should fulfill one of the following criteria:
• Post-menopausal; either amenorrhea ≥12 months or follicle stimulating hormone \>40 mIU/mL (milli-international units/milliliter) as documented in their medical history
• Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation
• Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening until 60 days post infusion
• Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method when having heterosexual intercourse, from screening until 60 days post infusion
• Test positive for influenza A by Rapid Antigen Test performed with a commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions
• Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of moderate to severe intensity, or presence of at least one constitutional symptom (myalgia \[aches and pains\], headache, feverishness, or fatigue) of moderate to severe intensity
• Onset of symptoms (time when the temperature was first measured as elevated \[temperature of ≥100.4°F or ≥38°C\], OR the time when the subject experienced at least one respiratory symptom or at least one constitutional symptom) no more than 72 hours before the start of infusion

You may not qualify if:

• Use of NSAIDs or antihistamines within 6 hours of study drug dosing with the exception of those used as part of the pretreatment regimen
• History of intolerance or allergic response to monoclonal antibodies and/or pretreatment medications (diphenhydramine, ibuprofen and acetylsalicylic acid)
• Subject weight less than (\<) 45 kg
• Subjects with clinical history that would lead to increased risk of influenza complications including but not limited to clinically significant cardiac disease, moderate to severe asthma, or other moderate to severe chronic obstructive pulmonary disease, metabolic syndrome including moderate to severe diabetes or active tuberculosis
• History of chronic GI disease, including bleeding, ulceration, Irritable Bowel Syndrome, systemic mastocytosis or chronic diarrhea
• Women who are pregnant, breast-feeding, or considering becoming pregnant
• Patients with hypoxemia requiring oxygen support
• Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the Investigator's opinion, indicates that such finding(s) could represent complications of influenza
• Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy including systemic steroids
• Presence of known Acquired Immune Deficiency Syndrome-defining illness, chronic hepatitis B or hepatitis C
• Receipt of any dose of antiviral therapy such as, but not limited to, rimantadine, amantadine, peramivir, zanamivir, laninamivir or oseltamivir in the 7 days prior to screening
• Enrollment in any other investigational drug or device study, any disease or vaccine study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer
• Subjects unable to take oral predose medication
• Known or suspected alcohol or drug abuse, that is, abuse of a level that would compromise the safety or cooperation of the subject in the opinion of the Investigator
• Subjects on chronic medications where the dose has not been stable for at least 3 months

Sponsors & Collaborators

• Visterra, Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (54)

Unknown Facility

Huntsville, Alabama, 35801, United States

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Coral Gables, Florida, 33134, United States

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Homestead, Florida, 33033, United States

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Miami, Florida, 33165, United States

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Miami, Florida, 33185, United States

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Orlando, Florida, 32811, United States

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Eunice, Louisiana, 70535, United States

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New Orleans, Louisiana, 70115, United States

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Shelby, North Carolina, 28150, United States

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Houston, Texas, 77058, United States

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McAllen, Texas, 78504, United States

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Asenovgrad, 4230, Bulgaria

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Lom, 3600, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1202, Bulgaria

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Sofia, 1407, Bulgaria

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Velingrad, 4600, Bulgaria

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Paide, 72713, Estonia

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Tallinn, 10617, Estonia

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Tallinn, 11615, Estonia

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Tallinn, 13415, Estonia

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Daugavpils, LV-5417, Latvia

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Liepāja, LV-3414, Latvia

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Rēzekne, LV-4600, Latvia

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Riga, LV-1010, Latvia

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Valmiera, LV-4201, Latvia

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Ventspils, LV-3601, Latvia

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Kragujevac, 34000, Serbia

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Niš, 18000, Serbia

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Novi Sad, 21000, Serbia

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Welkom, Free State, 9460, South Africa

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Benoni, Gauteng, 1500, South Africa

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Centurion, Gauteng, 1692, South Africa

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Johannesburg, Gauteng, 2113, South Africa

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Kempton Park, Gauteng, 1619, South Africa

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Pretoria, Gauteng, 0121, South Africa

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Pretoria West, Gauteng, 0183, South Africa

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Soshanguve, Gauteng, 0152, South Africa

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Soweto, Gauteng, 2013, South Africa

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Durban, KwaZulu-Natal, 4092, South Africa

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Thabazimbi, Limpopo, 0380, South Africa

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Middelburg, Mpumalanga, 1055, South Africa

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Witbank, Mpumalanga, 1035, South Africa

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Cape Town, Western Cape, 7570, South Africa

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Worcester, Western Cape, 6850, South Africa

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Kharkiv, 61064, Ukraine

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Kharkiv, 61106, Ukraine

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Kiev, 03049, Ukraine

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Kiev, 03110, Ukraine

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Kiev, 04050, Ukraine

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Odesa, 65023, Ukraine

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Sumy, 40021, Ukraine

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Vinnytsia, 21001, Ukraine

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Vinnytsia, 21029, Ukraine

Location

Related Publications (1)

• Hershberger E, Sloan S, Narayan K, Hay CA, Smith P, Engler F, Jeeninga R, Smits S, Trevejo J, Shriver Z, Oldach D. Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study. EBioMedicine. 2019 Feb;40:574-582. doi: 10.1016/j.ebiom.2018.12.051. Epub 2019 Jan 9.

  PMID: 30638863 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Visterra

clinicaltrials@visterrainc.com

617-498-1070

Study Officials

• Clinical Development

  Visterra, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 12, 2016
• Study Start: January 6, 2017
• Primary Completion: October 27, 2017
• Study Completion: October 27, 2017
• Last Updated: August 15, 2022
• Results First Posted: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

UA (9); BU (6); SE (3); US (11); ES (4); LA (6); ZA (15)