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Not yet recruiting NCT07387302

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

Phase II Interventional Paroxysmal Nocturnal Hemoglobinuria (PNH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SLN12140.
Who it may be relevant to
Registry conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II Clinical Study Evaluating SLN12140 in Complement Inhibitor-Naïve Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria

Overview

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.

Interventions

  • Drug SLN12140
    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

Primary outcome measures

  • During the 12-week treatment period, the proportion of participants whose Lactate Dehydrogenase (LDH) decreased by 60% or more from baseline or whose LDH was below the upper limit [Time frame: 12weeks after baseline]
Secondary outcome measures (12)
  • Percentage change of LDH from baseline [Time frame: Baseline through Week 64]
  • Proportion of participants achieving hemolysis control (LDH ≤ 1.5×ULN) [Time frame: Baseline through Week 64]
  • Change in hemoglobin (Hb) levels from baseline [Time frame: Baseline through week 64]
  • The proportion of participants whose hemoglobin (Hb) increased by ≥2 g/dL from baseline and who avoided blood transfusion [Time frame: Baseline through Week 64]
  • Proportion of participants who avoided blood transfusion [Time frame: Baseline through Week 64]
  • Incidence(%) of Breakthrough Hemolysis (BTH) [Time frame: Baseline through Week 64]
  • Changes from baseline in intravascular and extravascular hemolysis indicators (including but not limited to reticulocytes, bilirubin, red blood cell count, platelet count, ferritin, etc.) [Time frame: baseline through week 64]
  • Changes in thrombus formation risk markers from baseline (including but not limited to fibrinogen, prothrombin time, activated partial thromboplastin time, thrombin time, fibrin D-dimer, etc.); [Time frame: Baseline through week 64]
  • Change in functional assessment of Functional Assessment of Chronic Illness Therapy (FACIT) [Time frame: Baseline through Week 64]
  • Number(%) of participants with Adverse Events (AEs) , Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: Baseline through Week 64]
  • Pharmacokinetics (PK)parameters of SLN12140: Area Under The Plasma Concentration-time Curve [Time frame: Baseline through week 64 (predose and postdose)]
  • Immunegenicity in Paraxysmal Nocturnal Hemoglobinuria [Time frame: Baseline through Week 64]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07387302 · LIN2102-CN201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗