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An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis

NCT ID: NCT05214794

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-20

Study Completion Date

2024-07-30

Brief Summary

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To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.

Detailed Description

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Conditions

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Systemic Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nemolizumab

Group Type EXPERIMENTAL

nemolizumab

Intervention Type DRUG

nemolizumab will be administered subcutaneous injection

Interventions

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nemolizumab

nemolizumab will be administered subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Systemic Sclerosis according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria
* Systemic Sclerosis patients with moderate to sever skin sclerosis

Exclusion Criteria

* Patients witg a disease considered inappropriate for participation in clinical trials, such as serious cardiac / hepatic / renal / pulmonary / hematologic disease
* Patients with a diseases that could interfere with assessment of Systemic Scleorosis
* Patients with body weight less than 30.0kg
* Pregnant or lactating women.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maruho Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ayumi Yoshizaki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tokyo University

Locations

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The University of Tokyo Hospital

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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M525101-21

Identifier Type: -

Identifier Source: org_study_id