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Study of KHK 4323 in Healthy Volunteers and Subjects With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Terminated

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

KHK4323 IV/S

KHK4323 SC/S

KHK4323 IV/M

Placebo IV/S

Placebo IV/M

Placebo SC/S

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Part 1:

Japanese or Caucasian male aged 20 to under 45 years old at the time consent was obtained
BMI ≥ 18.5 to < 30.0 at time of screening tests

Part 2:

Men and women aged 18 years or older at the time of consent
Patients with EASI ≥ 16 in pre-administration testing
Patients with IGA of "3: Moderate" or higher in pre-administration testing
Patients with BSA ≥ 10% at screening in pre-administration testing

"Exclusion Criteria:

Part 1:

Persons with existing respiratory disease, heart disease, gastrointestinal disease, kidney disease, or liver disease
Persons confirmed to have a bacterial, viral, fungal, or parasitic infection within 28 days prior to obtainment of consent
Persons who have contracted an infectious disease requiring hospitalization or IV administration of an antibiotic within 6 months prior to obtainment of consent
Persons who have been treated with a biological preparation (antibody, etc.) or have been administered an investigational drug within 6 months prior to the obtainment of consent
Persons who have used a medication (including over-the-counter drugs, topical agents, vitamins, and herbal medicines) within 2 weeks prior to obtainment of consent (for an immunosuppressant drug, within 60 days)
Persons who routinely smoke an average of more than 10 cigarettes a day (to be confirmed in interview at time of screening tests) or cannot follow the rules regarding smoking during the clinical trial period

Part 2:

Patients with severe complications judged to affect the implementation and evaluation of the study in the opinion of the investigator or sub-investigator. Includes but is not limited to the following. Severe cardiovascular disease (e.g., class III or IV according to New York Heart Association functional classification), poorly controlled diabetes mellitus (HbA1c > 8.5%), poorly controlled hypertension, liver disease with severity of moderate or higher (e.g., class B or C according to Child-Pugh classification), kidney disease, respiratory disease, gastrointestinal disease, blood dyscrasia, central nervous system disease, psychiatric disease, autoimmune disease, etc.
Patients observed to have one of the following laboratory test abnormalities in screening tests
- Neutrophil count: < 1500/μL
- Serum creatinine: > 1.5 mg/dL
- AST or ALT: > 2.5-fold the upper limit of the reference range
- Other laboratory test abnormalities that the investigator or sub-investigator thinks could affect the completion or evaluation of the clinical trial

Sites / Locations

Osaka Pharmacology Clinical research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part1 Dose 1A

Part1 Dose 1P

Part1 Dose 2A

Part1 Dose 2P

Part1 Dose 3A

Part1 Dose 3P

Part1 Dose 4A

Part1 Dose 4P

Part1 Dose 5A

Part1 Dose 5P

Part1 Dose 6A

Part1 Dose 6P

Part1 Dose 7A

Part1 Dose 7P

Part2 Dose 1A

Part2 Dose 1P

Part2 Dose 2A

Part2 Dose 2P

Arm Description

Single administration

Multiple administration

Outcomes

Primary Outcome Measures

Number of participants with adverse events

For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are classified by MedDRA PT and SOC and shown according to dose group.

Secondary Outcome Measures

Profile of pharmacokinetics of serum KHK4323 concentration in Part 1

Anti-KHK4323 antibodies

Profile of pharmacokinetics of serum KHK4323 concentration in Part 2

Anti-KHK4323 antibodies

Full Information

NCT ID

NCT03846466

First Posted

February 17, 2019

Last Updated

January 26, 2020

Sponsor

Kyowa Kirin Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03846466

Brief Title

Study of KHK 4323 in Healthy Volunteers and Subjects With Atopic Dermatitis

Official Title

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Dose or Multiple Dose Study of KHK4323 in Healthy Volunteers, and Subjects With Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Terminated

Why Stopped

The study terminated for safety reasons.

Study Start Date

February 22, 2019 (Actual)

Primary Completion Date

December 11, 2019 (Actual)

Study Completion Date

December 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kyowa Kirin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Part 1: To investigate the safety and tolerability of intravenous (IV) or subcutaneous (SC) administration of a single dose of KHK4323 to Japanese or Caucasian healthy adult males in a double-blind, placebo-controlled study. Part 2: To investigate the safety and tolerability of intravenous (IV) administration of repeated doses of KHK4323 to atopic dermatitis patients in a double-blind, placebo-controlled study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part1 Dose 1A

Arm Type

Experimental

Arm Description

Single administration

Arm Title

Part1 Dose 1P

Arm Type

Placebo Comparator

Arm Description

Single administration

Arm Title

Part1 Dose 2A

Arm Type

Experimental

Arm Description

Single administration

Arm Title

Part1 Dose 2P

Arm Type

Placebo Comparator

Arm Description

Single administration

Arm Title

Part1 Dose 3A

Arm Type

Experimental

Arm Description

Single administration

Arm Title

Part1 Dose 3P

Arm Type

Placebo Comparator

Arm Description

Single administration

Arm Title

Part1 Dose 4A

Arm Type

Experimental

Arm Description

Single administration

Arm Title

Part1 Dose 4P

Arm Type

Placebo Comparator

Arm Description

Single administration

Arm Title

Part1 Dose 5A

Arm Type

Experimental

Arm Description

Single administration

Arm Title

Part1 Dose 5P

Arm Type

Placebo Comparator

Arm Description

Single administration

Arm Title

Part1 Dose 6A

Arm Type

Experimental

Arm Description

Single administration

Arm Title

Part1 Dose 6P

Arm Type

Placebo Comparator

Arm Description

Single administration

Arm Title

Part1 Dose 7A

Arm Type

Experimental

Arm Description

Single administration

Arm Title

Part1 Dose 7P

Arm Type

Placebo Comparator

Arm Description

Single administration

Arm Title

Part2 Dose 1A

Arm Type

Experimental

Arm Description

Multiple administration

Arm Title

Part2 Dose 1P

Arm Type

Placebo Comparator

Arm Description

Multiple administration

Arm Title

Part2 Dose 2A

Arm Type

Experimental

Arm Description

Multiple administration

Arm Title

Part2 Dose 2P

Arm Type

Placebo Comparator

Arm Description

Multiple administration

Intervention Type

Drug

Intervention Name(s)

KHK4323 IV/S

Intervention Description

IV / Single administration

Intervention Type

Drug

Intervention Name(s)

KHK4323 SC/S

Intervention Description

SC / Single administration

Intervention Type

Drug

Intervention Name(s)

KHK4323 IV/M

Intervention Description

IV / Multiple administration

Intervention Type

Drug

Intervention Name(s)

Placebo IV/S

Intervention Description

IV / Single administration

Intervention Type

Drug

Intervention Name(s)

Placebo IV/M

Intervention Description

IV / Multiple administration

Intervention Type

Drug

Intervention Name(s)

Placebo SC/S

Intervention Description

SC / Single administration

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Description

Time Frame

Part 1: from Day 1 through at most Day 169, Part 2: from Day 1 through at most Day 225

Secondary Outcome Measure Information:

Title

Profile of pharmacokinetics of serum KHK4323 concentration in Part 1

Description

Anti-KHK4323 antibodies

Time Frame

Day 1 (pre-dose, 1, 6 hours after the start of administration) Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141, Day 169

Title

Profile of pharmacokinetics of serum KHK4323 concentration in Part 2

Description

Anti-KHK4323 antibodies

Time Frame

Day 1( pre-dose, 1 hours after the start of administration), Day 8, Day 15, Day 29,Day 43, Day 57, Day 85, Day 113, Day 169, Day 225

Other Pre-specified Outcome Measures:

Title

Change from baseline in Eczema Area and Severity Index (EASI)

Time Frame

Part2: Day1(Pre-dose), Day 15, Day 29,Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225

Title

Percent change in Eczema Area and Severity Index (EASI)

Time Frame

Part2: Day1(Pre-dose), Day 15, Day 29,Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225

Title

Change from baseline in Body surface area (BSA) of involvement of Atopic dermatitis

Time Frame

Part2 Day1(Pre-dose), Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225

Title

Percent change in Body surface area (BSA) of involvement of Atopic dermatitis

Time Frame

Part2 Day1(Pre-dose), Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225

Title

The number of subjects with IGA of 0 or 1 and improvement of 2 points or more over baseline score (IGA responders)

Time Frame

Part2 Day1(Pre-dose), Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225

Title

The percentage of subjects with IGA of 0 or 1 and improvement of 2 points or more over baseline score (IGA responders)

Time Frame

Part2 Day1(Pre-dose), Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Part 1: Japanese or Caucasian male aged 20 to under 45 years old at the time consent was obtained BMI ≥ 18.5 to < 30.0 at time of screening tests Part 2: Men and women aged 18 years or older at the time of consent Patients with EASI ≥ 16 in pre-administration testing Patients with IGA of "3: Moderate" or higher in pre-administration testing Patients with BSA ≥ 10% at screening in pre-administration testing "Exclusion Criteria: Part 1: Persons with existing respiratory disease, heart disease, gastrointestinal disease, kidney disease, or liver disease Persons confirmed to have a bacterial, viral, fungal, or parasitic infection within 28 days prior to obtainment of consent Persons who have contracted an infectious disease requiring hospitalization or IV administration of an antibiotic within 6 months prior to obtainment of consent Persons who have been treated with a biological preparation (antibody, etc.) or have been administered an investigational drug within 6 months prior to the obtainment of consent Persons who have used a medication (including over-the-counter drugs, topical agents, vitamins, and herbal medicines) within 2 weeks prior to obtainment of consent (for an immunosuppressant drug, within 60 days) Persons who routinely smoke an average of more than 10 cigarettes a day (to be confirmed in interview at time of screening tests) or cannot follow the rules regarding smoking during the clinical trial period Part 2: Patients with severe complications judged to affect the implementation and evaluation of the study in the opinion of the investigator or sub-investigator. Includes but is not limited to the following. Severe cardiovascular disease (e.g., class III or IV according to New York Heart Association functional classification), poorly controlled diabetes mellitus (HbA1c > 8.5%), poorly controlled hypertension, liver disease with severity of moderate or higher (e.g., class B or C according to Child-Pugh classification), kidney disease, respiratory disease, gastrointestinal disease, blood dyscrasia, central nervous system disease, psychiatric disease, autoimmune disease, etc. Patients observed to have one of the following laboratory test abnormalities in screening tests Neutrophil count: < 1500/μL Serum creatinine: > 1.5 mg/dL AST or ALT: > 2.5-fold the upper limit of the reference range Other laboratory test abnormalities that the investigator or sub-investigator thinks could affect the completion or evaluation of the clinical trial

Facility Information:

Facility Name

Osaka Pharmacology Clinical research Hospital

City

Osaka

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Study of KHK 4323 in Healthy Volunteers and Subjects With Atopic Dermatitis

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