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

Sponsor

Asahi Kasei Pharma Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT03471988

Collaborator

(none)

103

Enrollment

Locations

Arms

36.2

Actual Duration (Months)

3.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Deep Mycosis	Drug: AK1820 Drug: Voriconazole	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 16, 2018

Actual Primary Completion Date :

Apr 21, 2021

Actual Study Completion Date :

Apr 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AK1820 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.	Drug: AK1820 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
Active Comparator: Voriconazole 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.	Drug: Voriconazole 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

Arm

Intervention/Treatment

Experimental: AK1820

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.

Drug: AK1820

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

Active Comparator: Voriconazole

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.

Drug: Voriconazole

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

Outcome Measures

Primary Outcome Measures

Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up. [From the first study drug administration until 28 days after the last dose of study drug (up to approximately Day 112).]

Secondary Outcome Measures

Percentage of participants with an overall outcome of success evaluated by the data review committee (DRC). [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.]
Percentage of participants with clinical, radiological and mycological response assessed by the DRC. [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.]
Percentage of participants with overall outcome, clinical, radiological and mycological response evaluated by investigator. [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.]
All-cause mortality. [Through 28 days after the last dose of study drug (up to approximately Day 112).]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Research site	Nagakute	Aichi	Japan
2	Research site	Nagoya	Aichi	Japan
3	Research site	Seto	Aichi	Japan
4	Research site	Higashi-Ku	Fukuoka	Japan
5	Research site	Minami-Ku	Fukuoka	Japan
6	Research site	Nagara	Gifu	Japan
7	Research site	Naka-Ku	Hiroshima	Japan
8	Research site	Asahikawa	Hokkaido	Japan
9	Research site	Kawasaki	Kanagawa	Japan
10	Research site	Yokohama	Kanagawa	Japan
11	Research site	Chuo-Ku	Kumamoto	Japan
12	Research site	Tsu	Mie	Japan
13	Research site	Isahaya	Nagasaki	Japan
14	Research site	Sasebo	Nagasaki	Japan
15	Research site	Ōmura	Nagasaki	Japan
16	Research site	Tenri	Nara	Japan
17	Research site	Yufu	Oita	Japan
18	Research site	Kurashiki	Okayama	Japan
19	Research site	Nakagami	Okinawa	Japan
20	Research site	Abeno-Ku	Osaka	Japan
21	Research site	Sakai	Osaka	Japan
22	Research site	Ōmiya	Saitama	Japan
23	Research site	Hamamatsu	Shizuoka	Japan
24	Research site	Shimotsuke	Tochigi	Japan
25	Research site	Kiyose	Tokyo	Japan
26	Research site	Minato-Ku	Tokyo	Japan
27	Research site	Mitaka	Tokyo	Japan
28	Research site	Ota-Ku	Tokyo	Japan
29	Research site	Shinagawa-Ku	Tokyo	Japan
30	Research site	Shinjuku-Ku	Tokyo	Japan
31	Research site	Chiba		Japan
32	Research site	Ibaraki		Japan
33	Research site	Nagasaki		Japan