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NCT Number: NCT07387302

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

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.

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Key information

Conditions

Paroxysmal Nocturnal Hemoglobinuria (PNH) Anemia Anemia, Hemolytic Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinuria, Paroxysmal Myelodysplastic Syndromes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

    Time frame: 12weeks after baseline

    To assess efficacy of SLN12140 in participants with PNH

Secondary outcomes

  1. Percentage change of LDH from baseline

    Time frame: Baseline through Week 64

    To assess the efficacy of SLN12140 in participants with PNH

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

    Time frame: Baseline through Week 64

    To assess the efficacy of SLN12140 in participants with PNH

  3. Change in hemoglobin (Hb) levels from baseline

    Time frame: Baseline through week 64

    To assess the efficacy of SLN12140 in participants with PNH

  4. 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

    To assess the efficacy of SLN12140 in participants with PNH

  5. Proportion of participants who avoided blood transfusion

    Time frame: Baseline through Week 64

    To assess the efficacy of SLN12140 in participants with PNH

  6. Incidence(%) of Breakthrough Hemolysis (BTH)

    Time frame: Baseline through Week 64

    To assess the efficacy of SLN12140 in participants with PNH

  7. 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

    To assess the efficacy of SLN12140 in participants with PNH

  8. 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

    To assess the efficacy of SLN12140 in participants with PNH

  9. Change in functional assessment of Functional Assessment of Chronic Illness Therapy (FACIT)

    Time frame: Baseline through Week 64

    To assess the efficacy of SLN12140 in participants with PNH. FACIT is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function to assess the Impact of SLN12140 on Treatment-Related Outcomes. The minimum value is 0 and maximum value is 52, and higher scores mean a worse outcome.

  10. Number(%) of participants with Adverse Events (AEs) , Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline through Week 64

    To assess the safety and tolerability of SLN12140 in participants with PNH

  11. Pharmacokinetics (PK)parameters of SLN12140: Area Under The Plasma Concentration-time Curve

    Time frame: Baseline through week 64 (predose and postdose)

    To characterize the pharmacokinetics of SLN12140 in participants with PNH

  12. Immunegenicity in Paraxysmal Nocturnal Hemoglobinuria

    Time frame: Baseline through Week 64

    Determine anti-drug antibody titers

  13. PK: Maximum Plasma Concentration (Cmax)

    Time frame: Baseline through week 64( predose and postdose)

    To characterize the pharmacokinetics of SLN12140 in participants with PNH

  14. PK: Time To Maximum Concentration (Tmax)

    Time frame: Baseline through week 64( predose and postdose)

    To characterize the pharmacokinetics of SLN12140 in participants with PNH

  15. Complement Alternative Pathway (AP) Functional Activity

    Time frame: Baseline through week 64( predose and post dose)

    Serum AP functional activity was measured by the Wieslab functional immunoassay method.

  16. Complement FP

    Time frame: Baseline through week 64(predose and postdose)

    Plasma FP was measured by enzyme-linked immunosorbent assay (ELISA).

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Kui Zhang, Professor

CONTACT

[email protected]

86+ ext. 13821700281

Hong Yan Tong, Professor

CONTACT

[email protected]

86+13958122357

Sponsors and collaborators

Lead sponsor

Linno Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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