ClinicalTrials.gov record NCT07387302
SLN12140 in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
A Phase II Clinical Study Evaluating SLN12140 in Complement Inhibitor-Naïve Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Phase II study of SLN12140 in adults with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy. The trial includes screening, a core treatment period, an extended dosing period, and follow-up. Two dosing cohorts will enroll at least five treatment‑naïve adults each; SLN12140 is given by subcutaneous injection on cohort‑specific schedules.
What it is studying. The study evaluates different subcutaneous dosing schedules of SLN12140 to characterize safety, tolerability, and pharmacokinetics, and to measure effects on hemolysis, hemoglobin, transfusion avoidance, markers of thrombosis risk, and immunogenicity in complement inhibitor–naïve adults with PNH.
What the researchers hope to learn. To determine appropriate dosing and safety/tolerability of SLN12140, to describe its pharmacokinetics and immunogenicity, and to measure its effects on hemolysis, hemoglobin levels, transfusion requirements, and blood‑clot risk markers in PNH.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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 being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- SLN12140
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After a screening period, participants receive SLN12140 by subcutaneous injection according to one of two dosing schedules. The study includes a core treatment period, an extended dosing period, and follow‑up, with monitoring through Week 64. Participants will have regular safety checks and blood tests to measure hemolysis, drug levels, immune response, and other lab markers, and will complete questionnaires about symptoms/function. The study team will monitor and record adverse events and infections throughout participation.
How the study is structured. An interventional Phase II, open‑label (no masking) study with a single‑group model organized into two dosing cohorts. Participants receive SLN12140 by subcutaneous injection on predefined schedules and are followed with laboratory tests, safety monitoring, and pharmacokinetic and immunogenicity assessments through about 64 weeks.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on paroxysmal nocturnal hemoglobinuria
Important dates
- Study start
- Feb 10, 2026 (estimated)
- Primary completion
- Jul 31, 2026 (estimated)
- Study completion
- Dec 31, 2027 (estimated)
- Target enrollment
- 10 participants (estimated)
- Last updated on registry
- Feb 4, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Linno Pharmaceuticals, Inc.
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Hong Yan Tong, Professor 📞 86+13958122357 ✉ hongyantong@aliyun.com
- Feng Kui Zhang, Professor 📞 86+ ext. 13821700281 ✉ fkzhang@ihcams.ac.cn
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- pharmacokinetic
- How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
- screening period
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- treatment-naïve
- Has not previously received the treatment, or the type of treatment, that the study is about.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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