SLN12140 in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China

Linno Pharmaceuticals, Inc.

Status and phase: Begins enrollment this month; Phase 2

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Treatments: Drug: SLN12140

Study type: Interventional

Funder types: Industry

Identifiers

NCT07387302

LIN2102-CN201

Details and patient eligibility

About

The goal of this clinical trial is to learn if drug SLN12140 works to treat Complement Inhibitor-Naïve Subjects with Paroxysmal Nocturnal Hemoglobinuria in adults. It will also learn about the safety, pharmacokinetic characteristics, and dosing of drug SLN12140.

The study is divided into four phases: screening period, core treatment period, extended dosing period, and follow-up period, and includes two cohorts (Cohorts 1-2), with each cohort enrolling at least 5 treatment-naïve adult PNH subjects for complement inhibitor therapy.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult complement inhibitor naïve PNH patients (age>=18), which is confirmed by flow cytometry evaluation
• Must be vaccinated against meningococcal vaccine and pneumococcal vaccine

Exclusion criteria

• Significant bone marrow failure
• Meningitidis infection or unresolved meningococcal disease
• Other significant systemic diseases that might have impact on efficacy and safety assessment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

SLN 12140 will be administered subcutaneously .

Experimental group

Description:

5 participants will receive SLN12140 100mg QW for 4 weeks, then 300mg QW for 8 weeks, then 200mg QW for 52 weeks. 5 participants will receive SLN12140 200mg QW for 4 weeks, then 600mg Q4W for 60 weeks

Treatment:

Drug: SLN12140