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

Maruho

Status and phase: Completed; Phase 2

Conditions: Systemic Sclerosis

Treatments: Drug: nemolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05214794

M525101-21

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

nemolizumab

Experimental group

Treatment:

Drug: nemolizumab