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

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ClinicalTrials.gov Identifier: NCT03703102
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Kyowa Kirin Co., Ltd.
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc.

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: KHK4083 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: subcutaneous administration
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis (AD)
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Placebo Comparator: Arm A
Subcutaneous administration of placebo
Drug: Placebo
Matching placebo

Experimental: Arm B
Subcutaneous administration of KHK4083 (dose level 1, dosing regimen 2)
Drug: KHK4083
Anti-OX40 Monoclonal Antibody KHK4083

Experimental: Arm C
Subcutaneous administration of KHK4083 (dose level 2, dosing regimen 1)
Drug: KHK4083
Anti-OX40 Monoclonal Antibody KHK4083

Experimental: Arm D
Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 1)
Drug: KHK4083
Anti-OX40 Monoclonal Antibody KHK4083

Experimental: Arm E
Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 2)
Drug: KHK4083
Anti-OX40 Monoclonal Antibody KHK4083




Primary Outcome Measures :
  1. Percent change from baseline to Week 16 in Eczema Area and Severity Index (EASI) score [ Time Frame: Baseline to Week 16 ]
    EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703102


Contacts
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Contact: Kyowa Kirin Pharmaceutical Development, Inc. 1-609-919-1100 clinical.info@kyowakirin.com
Contact: Kyowa Hakko Kirin Co., Ltd.

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Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development, Inc.
Kyowa Kirin Co., Ltd.
Investigators
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Study Director: Ehsanollah Esfandiari, MD, PhD Kyowa Kirin Pharmaceutical International Ltd.

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Responsible Party: Kyowa Kirin Pharmaceutical Development, Inc.
ClinicalTrials.gov Identifier: NCT03703102     History of Changes
Other Study ID Numbers: 4083-006
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc.:
AD
eczema
skin diseases
biologics

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
KHK4083
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Dermatologic Agents