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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 December 2024
• Main ID: NCT05214794
• Date of registration: 17/01/2022
• Prospective Registration: Yes
• Primary sponsor: Maruho Co., Ltd.
• Public title: An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
• Scientific title: An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
• Date of first enrolment: April 20, 2022
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT05214794
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Japan

Contacts

• Name: Ayumi Yoshizaki, MD, PhD
• Affiliation: Tokyo University

Key inclusion & exclusion criteria

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.


Age minimum: 20 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Intervention(s)

Drug: nemolizumab

Primary Outcome(s)

Change from Baseline in modified Rodnan Skin Score (mRSS) at Week 24 [Time Frame: Baseline and week 24]

Secondary ID(s)

M525101-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors