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

NCT03703102 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 4083-006
• Study Type: interventional
• Target: 274
• Locations: 4 countries
• Sites: 58

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

Keywords

AD; eczema; skin diseases; biologics

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score

  In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.

  Baseline to Week 16

Secondary Outcomes (23)

• Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16

  Baseline to Week 16

• Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score

  Baseline to Week 16

• Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score

  Baseline to Week 16

• Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score

  Baseline to Week 16

• Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16

  Baseline to Week 16

Study Arms (5)

Arm A

PLACEBO COMPARATOR

Subcutaneous administration of placebo

Drug: Placebo

Arm B

EXPERIMENTAL

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

Drug: KHK4083

Arm C

EXPERIMENTAL

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

Drug: KHK4083

Arm D

EXPERIMENTAL

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

Drug: KHK4083

Arm E

EXPERIMENTAL

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

Drug: KHK4083

Interventions

KHK4083 DRUG

Anti-OX40 Monoclonal Antibody KHK4083

Arm B; Arm C; Arm D; Arm E

Placebo DRUG

Matching placebo

Arm A

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kyowa Kirin, Inc.: lead
• Kyowa Kirin Co., Ltd.: collaborator

Study Sites (58)

Kyowa Investigational Site US-19

Huntington Beach, California, 92647, United States

Location

Kyowa Investigational Site US-17

Irvine, California, 92697, United States

Location

Kyowa Investigational Site US-09

Los Angeles, California, 90033, United States

Location

Kyowa Investigational Site US-05

Santa Ana, California, 92701, United States

Location

Kyowa Investigational Site US-10

Aurora, Colorado, 80010, United States

Location

Kyowa Investigational Site US-14

Clearwater, Florida, 33756, United States

Location

Kyowa Investigational Site US-04

Boston, Massachusetts, 02115, United States

Location

Kyowa Investigational Site US-01

New York, New York, 10029, United States

Location

Kyowa Investigational Site US-20

Charlotte, North Carolina, 28277, United States

Location

Kyowa Investigational Site US-11

Cleveland, Ohio, 44106, United States

Location

Kyowa Investigational Site US-08

Portland, Oregon, 97239, United States

Location

Kyowa Investigational Site US-02

Dallas, Texas, 75230, United States

Location

Kyowa Investigational Site US-07

Galveston, Texas, 77555, United States

Location

Kyowa Investigational Site CA-02

Markham, Ontario, Canada

Location

Kyowa Investigational Site CA-03

Richmond Hill, Ontario, Canada

Location

Kyowa Investigational Site CA-08

Richmond Hill, Ontario, Canada

Location

Kyowa Investigational Site CA-07

Québec, Quebec, Canada

Location

Kyowa Investigational Site CA-09

Québec, Quebec, Canada

Location

Kyowa Investigational Site CA-04

Sherbrooke, Quebec, Canada

Location

Kyowa Investigational Site GE-13

Aachen, Germany

Location

Kyowa Investigational Site GE-07

Berlin, Germany

Location

Kyowa Investigational Site GE-14

Berlin, Germany

Location

Kyowa Investigational Site GE-08

Darmstadt, Germany

Location

Kyowa Investigational Site GE-05

Frankfurt am Main, Germany

Location

Kyowa Investigational Site GE-02

Hamburg, Germany

Location

Kyowa Investigational Site GE-11

Hanover, Germany

Location

Kyowa Investigational Site GE-01

Langenau, Germany

Location

Kyowa Investigational Site JP-17

Aichi, Japan

Location

Kyowa Investigational Site JP-27

Aichi, Japan

Location

Kyowa Investigational Site JP-24

Chiba, Japan

Location

Kyowa Investigational Site JP-08

Fukuoka, Japan

Location

Kyowa Investigational Site JP-09

Fukuoka, Japan

Location

Kyowa Investigational Site JP-12

Fukuoka, Japan

Location

Kyowa Investigational Site JP-19

Fukuoka, Japan

Location

Kyowa Investigational Site JP-26

Fukuoka, Japan

Location

Kyowa Investigational Site JP-14

Gifu, Japan

Location

Kyowa Investigational Site JP-01

Hokkaido, Japan

Location

Kyowa Investigational Site JP-02

Hokkaido, Japan

Location

Kyowa Investigational Site JP-04

Hokkaido, Japan

Location

Kyowa Investigational Site JP-29

Hokkaido, Japan

Location

Kyowa Investigational Site JP-31

Ibaraki, Japan

Location

Kyowa Investigational Site JP-10

Kagoshima, Japan

Location

Kyowa Investigational Site JP-11

Kagoshima, Japan

Location

Kyowa Investigational Site JP-05

Kanagawa, Japan

Location

Kyowa Investigational Site JP-06

Kanagawa, Japan

Location

Kyowa Investigational Site JP-21

Kanagawa, Japan

Location

Kyowa Investigational Site JP-18

Mie, Japan

Location

Kyowa Investigational Site JP-20

Miyagi, Japan

Location

Kyowa Investigational Site JP-28

Morioka, Japan

Location

Kyowa Investigational Site JP-25

Shimane, Japan

Location

Kyowa Investigational Site JP-15

Tochigi, Japan

Location

Kyowa Investigational Site JP-03

Tokyo, Japan

Location

Kyowa Investigational Site JP-07

Tokyo, Japan

Location

Kyowa Investigational Site JP-13

Tokyo, Japan

Location

Kyowa Investigational Site JP-16

Tokyo, Japan

Location

Kyowa Investigational Site JP-22

Tokyo, Japan

Location

Kyowa Investigational Site JP-23

Tokyo, Japan

Location

Kyowa Investigational Site JP-30

Tokyo, Japan

Location

Related Publications (2)

• 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.

  PMID: 39532780 DERIVED

• 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.

  PMID: 36509097 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Skin Diseases

Interventions

KHK4083

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Research & Development Planning Department, Research & Development Division
• Organization: Kyowa Kirin Co., Ltd.

clinical.info.jp@kyowakirin.com

+81-3-5205-7200

Study Officials

• Ehsanollah Esfandiari, MD, PhD

  Kyowa Kirin Pharmaceutical International Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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

Model Details: subcutaneous administration

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 11, 2018
• Study Start: October 22, 2018
• Primary Completion: February 6, 2020
• Study Completion: November 12, 2020
• Last Updated: April 26, 2024
• Results First Posted: June 9, 2022

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); JP (31); US (13); CA (6)