Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis

NCT ID: NCT03703102

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-22
• Study Completion Date: 2020-11-12

Brief Summary

A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm A

Subcutaneous administration of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo

Arm B

Subcutaneous administration of KHK4083 (dose level 1, dosing regimen 2)

Group Type: EXPERIMENTAL

KHK4083

Intervention Type: DRUG

Anti-OX40 Monoclonal Antibody KHK4083

Arm C

Subcutaneous administration of KHK4083 (dose level 2, dosing regimen 1)

Group Type: EXPERIMENTAL

KHK4083

Intervention Type: DRUG

Anti-OX40 Monoclonal Antibody KHK4083

Arm D

Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 1)

Group Type: EXPERIMENTAL

KHK4083

Intervention Type: DRUG

Anti-OX40 Monoclonal Antibody KHK4083

Arm E

Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 2)

Group Type: EXPERIMENTAL

KHK4083

Intervention Type: DRUG

Anti-OX40 Monoclonal Antibody KHK4083

Interventions

KHK4083

Anti-OX40 Monoclonal Antibody KHK4083

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Voluntarily signed informed consent to participate in the study;
• Chronic AD, according to American Academy of Dermatology Consensus Criteria or the local diagnostic criteria, that has been present for at least 1 year before screening;
• EASI score ≥16 at screening and baseline;
• IGA score ≥3 (moderate) at both screening and baseline;
• BSA ≥10% at both screening and baseline;
• Documented recent history (within 1 year prior to screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).

Exclusion Criteria

• Current or past history of clinically significant illness(es) deemed by the Investigator to be likely to affect the study conduct and assessments. Examples include, but are not limited to, clinically significant cardiovascular (e.g., New York Heart Association [NYHA] Class III or IV), uncontrolled diabetes (HbA1c ≥9%), liver (e.g., Child-Pugh class B or C), renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders;
• Any of the following laboratory abnormalities at screening:

• Serum creatinine: >1.5 mg/dL
• AST or ALT: ≥2.5 times the upper limit of normal (ULN)
• Neutrophil count: <1.5×10³/μL
• Other laboratory abnormalities that may affect the completion or evaluation of the study, as judged by the Investigator;
• Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Kyowa Kirin, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ehsanollah Esfandiari, MD, PhD

Role: STUDY_DIRECTOR

Kyowa Kirin Pharmaceutical International Ltd.

Locations

Kyowa Investigational Site US-19

Huntington Beach, California, United States

Kyowa Investigational Site US-17

Irvine, California, United States

Kyowa Investigational Site US-09

Los Angeles, California, United States

Kyowa Investigational Site US-05

Santa Ana, California, United States

Kyowa Investigational Site US-10

Aurora, Colorado, United States

Kyowa Investigational Site US-14

Clearwater, Florida, United States

Kyowa Investigational Site US-04

Boston, Massachusetts, United States

Kyowa Investigational Site US-01

New York, New York, United States

Kyowa Investigational Site US-20

Charlotte, North Carolina, United States

Kyowa Investigational Site US-11

Cleveland, Ohio, United States

Kyowa Investigational Site US-08

Portland, Oregon, United States

Kyowa Investigational Site US-02

Dallas, Texas, United States

Kyowa Investigational Site US-07

Galveston, Texas, United States

Kyowa Investigational Site CA-02

Markham, Ontario, Canada

Kyowa Investigational Site CA-03

Richmond Hill, Ontario, Canada

Kyowa Investigational Site CA-08

Richmond Hill, Ontario, Canada

Kyowa Investigational Site CA-07

Québec, Quebec, Canada

Kyowa Investigational Site CA-09

Québec, Quebec, Canada

Kyowa Investigational Site CA-04

Sherbrooke, Quebec, Canada

Kyowa Investigational Site GE-13

Aachen, , Germany

Kyowa Investigational Site GE-07

Berlin, , Germany

Kyowa Investigational Site GE-14

Berlin, , Germany

Kyowa Investigational Site GE-08

Darmstadt, , Germany

Kyowa Investigational Site GE-05

Frankfurt am Main, , Germany

Kyowa Investigational Site GE-02

Hamburg, , Germany

Kyowa Investigational Site GE-11

Hanover, , Germany

Kyowa Investigational Site GE-01

Langenau, , Germany

Kyowa Investigational Site JP-17

Aichi, , Japan

Kyowa Investigational Site JP-27

Aichi, , Japan

Kyowa Investigational Site JP-24

Chiba, , Japan

Kyowa Investigational Site JP-08

Fukuoka, , Japan

Kyowa Investigational Site JP-09

Fukuoka, , Japan

Kyowa Investigational Site JP-12

Fukuoka, , Japan

Kyowa Investigational Site JP-19

Fukuoka, , Japan

Kyowa Investigational Site JP-26

Fukuoka, , Japan

Kyowa Investigational Site JP-14

Gifu, , Japan

Kyowa Investigational Site JP-01

Hokkaido, , Japan

Kyowa Investigational Site JP-02

Hokkaido, , Japan

Kyowa Investigational Site JP-04

Hokkaido, , Japan

Kyowa Investigational Site JP-29

Hokkaido, , Japan

Kyowa Investigational Site JP-31

Ibaraki, , Japan

Kyowa Investigational Site JP-10

Kagoshima, , Japan

Kyowa Investigational Site JP-11

Kagoshima, , Japan

Kyowa Investigational Site JP-05

Kanagawa, , Japan

Kyowa Investigational Site JP-06

Kanagawa, , Japan

Kyowa Investigational Site JP-21

Kanagawa, , Japan

Kyowa Investigational Site JP-18

Mie, , Japan

Kyowa Investigational Site JP-20

Miyagi, , Japan

Kyowa Investigational Site JP-28

Morioka, , Japan

Kyowa Investigational Site JP-25

Shimane, , Japan

Kyowa Investigational Site JP-15

Tochigi, , Japan

Kyowa Investigational Site JP-03

Tokyo, , Japan

Kyowa Investigational Site JP-07

Tokyo, , Japan

Kyowa Investigational Site JP-13

Tokyo, , Japan

Kyowa Investigational Site JP-16

Tokyo, , Japan

Kyowa Investigational Site JP-22

Tokyo, , Japan

Kyowa Investigational Site JP-23

Tokyo, , Japan

Kyowa Investigational Site JP-30

Tokyo, , Japan

Countries

United States; Canada; Germany; Japan

References

Gooderham M, Guttman-Yassky E, Igawa K, Kabashima K, Esfandiari E, Rylands AJ, Williams A, Nixon A, Dent JE, Simpson E. Rocatinlimab Improves Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Double-Blind Placebo-Controlled Phase 2b Study. Dermatol Ther (Heidelb). 2024 Dec;14(12):3351-3366. doi: 10.1007/s13555-024-01303-z. Epub 2024 Nov 12.

Reference Type: DERIVED

PMID: 39532780 (View on PubMed)

Guttman-Yassky E, Simpson EL, Reich K, Kabashima K, Igawa K, Suzuki T, Mano H, Matsui T, Esfandiari E, Furue M. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. Lancet. 2023 Jan 21;401(10372):204-214. doi: 10.1016/S0140-6736(22)02037-2. Epub 2022 Dec 9.

Reference Type: DERIVED

PMID: 36509097 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

4083-006

Identifier Type: -

Identifier Source: org_study_id