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

ConditionParoxysmal Nocturnal Hemoglobinuria (PNH)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLinno Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult complement inhibitor naïve PNH patients (age>=18), which is confirmed by flow cytometry evaluation

Must be vaccinated against meningococcal vaccine and pneumococcal vaccine

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • SLN12140

    Drug

    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 groups

10 Participants
are divided into 1 treatment group
Group A: SLN 12140 will be administered subcutaneously .Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

To assess efficacy of SLN12140 in participants with PNH

Time frame
12weeks after baseline

Secondary outcomes

1

Percentage change of LDH from baseline

To assess the efficacy of SLN12140 in participants with PNH

Time frame
Baseline through Week 64
2

Proportion of participants achieving hemolysis control (LDH ≤ 1.5×ULN)

To assess the efficacy of SLN12140 in participants with PNH

Time frame
Baseline through Week 64
3

Change in hemoglobin (Hb) levels from baseline

To assess the efficacy of SLN12140 in participants with PNH

Time frame
Baseline through week 64
4

The proportion of participants whose hemoglobin (Hb) increased by ≥2 g/dL from baseline and who avoided blood transfusion

To assess the efficacy of SLN12140 in participants with PNH

Time frame
Baseline through Week 64

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Linno Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: