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

• Sponsor: Maruho Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05214794
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 18.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Systemic Sclerosis	Drug: nemolizumab	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
• Actual Study Start Date: Apr 20, 2022
• Anticipated Primary Completion Date: Jul 4, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nemolizumab	Drug: nemolizumab; nemolizumab will be administered subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. Change from Baseline in modified Rodnan Skin Score (mRSS) at Week 24 [Baseline and week 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Tokyo Hospital	Tokyo		Japan

Sponsors and Collaborators

• Maruho Co., Ltd.

Investigators

• Principal Investigator: Ayumi Yoshizaki, MD, PhD, Tokyo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maruho Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05214794
• Other Study ID Numbers: M525101-21
• First Posted: Jan 31, 2022
• Last Update Posted: May 17, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis

Study Results

No Results Posted as of May 17, 2022