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

NCT03703102 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2024-04-26

Study results available
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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

Interventions

DRUG

KHK4083

Anti-OX40 Monoclonal Antibody KHK4083

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    collaborator INDUSTRY
  • Kyowa Kirin, Inc.

    lead INDUSTRY

Principal Investigators

  • Ehsanollah Esfandiari, MD, PhD · Kyowa Kirin Pharmaceutical International Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2020-02-06
Completion
2020-11-12
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Japan

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03703102 on ClinicalTrials.gov