search
Back to results

Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis

Primary Purpose

Deep Mycosis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
AK1820
Voriconazole
Sponsored by
Asahi Kasei Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Mycosis focused on measuring deep mycosis, aspergillosis, mucormycosis, cryptococcosis, isavuconazonium sulfate, isavuconazole, AK1820, Cresemba

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  • Patients must have the below proven, probable or possible deep mycosis;

    1. invasive aspergillosis
    2. chronic pulmonary aspergillosis
    3. mucormycosis
    4. cryptococcosis
  • Female patients must be non-lactating and at no risk for pregnancy.

Main Exclusion Criteria:

  • Women who are pregnant or breastfeeding.
  • Patients with hypersensitivity to any of the components of the azole class of antifungals or the investigational product.
  • Patients at high risk for QT/QTc prolongation, or patients with risk factors for torsades de pointes, or taking concomitant medications known to prolong the QT/QTc interval.
  • Patients with a history of short QT syndrome.
  • Patients with liver dysfunction at enrollment.
  • Patients with moderate to severe kidney dysfunction at enrollment.
  • Patients who receive prohibited concomitant drugs.
  • Patients with any other fungal infection other than Aspergillus species, order Mucorales, or Cryptococcus species.
  • Patients who are not expected to survive study duration.
  • Patients with an underlying disease, complication or general condition that would complicate safety and efficacy evaluations.
  • Patients with a history of taking voriconazole for deep mycosis and showing no response to this treatment.
  • Patients taking systemic antifungals who are unable to stop taking these drugs during the study, or who are showing signs of improvement in their symptoms of deep mycosis as a result of these drugs.

Sites / Locations

  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AK1820

Voriconazole

Arm Description

Participants will receive a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) or orally for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they will reach a treatment endpoint or for a maximum of 84 days.

Participants will receive a loading dose of voriconazole, 6 mg/kg every 12 hours IV or 300 mg every 12 hours orally for the first 24 hours, followed by a maintenance dose from Day 2 of 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they will reach a treatment endpoint or for a maximum of 84 days.

Outcomes

Primary Outcome Measures

Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up.

Secondary Outcome Measures

Percentage of participants with an overall outcome of success evaluated by the data review committee (DRC).
Percentage of participants with clinical, radiological and mycological response assessed by the DRC.
Percentage of participants with overall outcome, clinical, radiological and mycological response evaluated by investigator.
All-cause mortality.

Full Information

First Posted
February 26, 2018
Last Updated
May 13, 2021
Sponsor
Asahi Kasei Pharma Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT03471988
Brief Title
Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis
Official Title
A Phase 3, Multi-center, Open Label Study to Evaluate Safety and Efficacy of AK1820 for Treatment of Adult Japanese Patients With Deep Mycosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
April 21, 2021 (Actual)
Study Completion Date
April 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asahi Kasei Pharma Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective of this study is to investigate the safety and efficacy of administering 372.6 mg of AK1820 (isavuconazonium sulfate) intravenously or orally to adult Japanese patients with deep mycosis. The primary endpoint is safety (percentage of patients with adverse events after starting the study treatment).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Mycosis
Keywords
deep mycosis, aspergillosis, mucormycosis, cryptococcosis, isavuconazonium sulfate, isavuconazole, AK1820, Cresemba

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AK1820
Arm Type
Experimental
Arm Description
Participants will receive a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) or orally for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they will reach a treatment endpoint or for a maximum of 84 days.
Arm Title
Voriconazole
Arm Type
Active Comparator
Arm Description
Participants will receive a loading dose of voriconazole, 6 mg/kg every 12 hours IV or 300 mg every 12 hours orally for the first 24 hours, followed by a maintenance dose from Day 2 of 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they will reach a treatment endpoint or for a maximum of 84 days.
Intervention Type
Drug
Intervention Name(s)
AK1820
Intervention Description
Only a switch from IV infusion (vial) to oral administration (capsule) will be permitted; a switch from oral administration to IV infusion will not be possible. 372.6 mg of AK1820 (isavuconazonium sulfate) is equivalent to 200 mg of isavuconazole. Other Names: Cresemba, BAL8557
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Intervention Description
Only a switch from IV infusion (vial) to oral administration (tablet) will be permitted; a switch from oral administration to IV infusion will not be possible. Other Name : VFend
Primary Outcome Measure Information:
Title
Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up.
Time Frame
From the first study drug administration until 28 days after the last dose of study drug (up to approximately Day 112).
Secondary Outcome Measure Information:
Title
Percentage of participants with an overall outcome of success evaluated by the data review committee (DRC).
Time Frame
Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.
Title
Percentage of participants with clinical, radiological and mycological response assessed by the DRC.
Time Frame
Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.
Title
Percentage of participants with overall outcome, clinical, radiological and mycological response evaluated by investigator.
Time Frame
Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.
Title
All-cause mortality.
Time Frame
Through 28 days after the last dose of study drug (up to approximately Day 112).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Patients must have the below proven, probable or possible deep mycosis; invasive aspergillosis chronic pulmonary aspergillosis mucormycosis cryptococcosis Female patients must be non-lactating and at no risk for pregnancy. Main Exclusion Criteria: Women who are pregnant or breastfeeding. Patients with hypersensitivity to any of the components of the azole class of antifungals or the investigational product. Patients at high risk for QT/QTc prolongation, or patients with risk factors for torsades de pointes, or taking concomitant medications known to prolong the QT/QTc interval. Patients with a history of short QT syndrome. Patients with liver dysfunction at enrollment. Patients with moderate to severe kidney dysfunction at enrollment. Patients who receive prohibited concomitant drugs. Patients with any other fungal infection other than Aspergillus species, order Mucorales, or Cryptococcus species. Patients who are not expected to survive study duration. Patients with an underlying disease, complication or general condition that would complicate safety and efficacy evaluations. Patients with a history of taking voriconazole for deep mycosis and showing no response to this treatment. Patients taking systemic antifungals who are unable to stop taking these drugs during the study, or who are showing signs of improvement in their symptoms of deep mycosis as a result of these drugs.
Facility Information:
Facility Name
Research site
City
Nagakute
State/Province
Aichi
Country
Japan
Facility Name
Research site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research site
City
Seto
State/Province
Aichi
Country
Japan
Facility Name
Research site
City
Higashi-Ku
State/Province
Fukuoka
Country
Japan
Facility Name
Research site
City
Minami-Ku
State/Province
Fukuoka
Country
Japan
Facility Name
Research site
City
Nagara
State/Province
Gifu
Country
Japan
Facility Name
Research site
City
Naka-Ku
State/Province
Hiroshima
Country
Japan
Facility Name
Research site
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Research site
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Research site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Research site
City
Chuo-Ku
State/Province
Kumamoto
Country
Japan
Facility Name
Research site
City
Tsu
State/Province
Mie
Country
Japan
Facility Name
Research site
City
Isahaya
State/Province
Nagasaki
Country
Japan
Facility Name
Research site
City
Sasebo
State/Province
Nagasaki
Country
Japan
Facility Name
Research site
City
Ōmura
State/Province
Nagasaki
Country
Japan
Facility Name
Research site
City
Tenri
State/Province
Nara
Country
Japan
Facility Name
Research site
City
Yufu
State/Province
Oita
Country
Japan
Facility Name
Research site
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Research site
City
Nakagami
State/Province
Okinawa
Country
Japan
Facility Name
Research site
City
Abeno-Ku
State/Province
Osaka
Country
Japan
Facility Name
Research site
City
Sakai
State/Province
Osaka
Country
Japan
Facility Name
Research site
City
Ōmiya
State/Province
Saitama
Country
Japan
Facility Name
Research site
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Facility Name
Research site
City
Shimotsuke
State/Province
Tochigi
Country
Japan
Facility Name
Research site
City
Kiyose
State/Province
Tokyo
Country
Japan
Facility Name
Research site
City
Minato-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Research site
City
Mitaka
State/Province
Tokyo
Country
Japan
Facility Name
Research site
City
Ota-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Research site
City
Shinagawa-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Research site
City
Shinjuku-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Research site
City
Chiba
Country
Japan
Facility Name
Research site
City
Ibaraki
Country
Japan
Facility Name
Research site
City
Nagasaki
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36307059
Citation
Kohno S, Izumikawa K, Takazono T, Miyazaki T, Yoshida M, Kamei K, Ogawa K, Taniguchi S, Akashi K, Tateda K, Mukae H, Miyazaki Y, Okada F, Kanda Y, Kakeya H, Suzuki J, Kimura SI, Kishida M, Matsuda M, Niki Y. Efficacy and safety of isavuconazole against deep-seated mycoses: A phase 3, randomized, open-label study in Japan. J Infect Chemother. 2023 Feb;29(2):163-170. doi: 10.1016/j.jiac.2022.10.010. Epub 2022 Oct 25.
Results Reference
derived
PubMed Identifier
35191210
Citation
Shirae S, Ose A, Kumagai Y. Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Isavuconazonium Sulfate in Healthy Adult Japanese Subjects. Clin Pharmacol Drug Dev. 2022 Jun;11(6):744-753. doi: 10.1002/cpdd.1079. Epub 2022 Feb 21.
Results Reference
derived

Learn more about this trial

Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis

We'll reach out to this number within 24 hrs