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Paroxysmal Nocturnal Hemoglobinuria (PNH)Phase 2NCT07387302

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

A Phase 2 study testing SLN12140 in people with Paroxysmal Nocturnal Hemoglobinuria (PNH), run by Linno Pharmaceuticals, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
SLN12140
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
10 Feb 2026to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hong Yan Tong, Professor contact

86+13958122357

hongyantong@aliyun.com

Feng Kui Zhang, Professor contact

86+ ext. 13821700281

fkzhang@ihcams.ac.cn

About this study

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

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.

Being tested
SLN12140
Medical subject headings
Hemoglobinuria, Paroxysmal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SLN12140Drug

    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

Study groups in NCT07387302
Study groupRoleWhat they receive
SLN 12140 will be administered subcutaneously .Experimental5 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
Receives: Drug: SLN12140

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12weeks after baseline

Secondary outcomes (16)

  1. Percentage change of LDH from baseline

    To assess the efficacy of SLN12140 in participants with PNH

    Measured: 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

    Measured: Baseline through Week 64

  3. Change in hemoglobin (Hb) levels from baseline

    To assess the efficacy of SLN12140 in participants with PNH

    Measured: 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

    Measured: Baseline through Week 64

  5. Proportion of participants who avoided blood transfusion

    To assess the efficacy of SLN12140 in participants with PNH

    Measured: Baseline through Week 64

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

    To assess the efficacy of SLN12140 in participants with PNH

    Measured: Baseline through Week 64

  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.)

    To assess the efficacy of SLN12140 in participants with PNH

    Measured: baseline through week 64

  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.);

    To assess the efficacy of SLN12140 in participants with PNH

    Measured: Baseline through week 64

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

    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.

    Measured: Baseline through Week 64

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

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

    Measured: Baseline through Week 64

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

    To characterize the pharmacokinetics of SLN12140 in participants with PNH

    Measured: Baseline through week 64 (predose and postdose)

  12. Immunegenicity in Paraxysmal Nocturnal Hemoglobinuria

    Determine anti-drug antibody titers

    Measured: Baseline through Week 64

  13. PK: Maximum Plasma Concentration (Cmax)

    To characterize the pharmacokinetics of SLN12140 in participants with PNH

    Measured: Baseline through week 64( predose and postdose)

  14. PK: Time To Maximum Concentration (Tmax)

    To characterize the pharmacokinetics of SLN12140 in participants with PNH

    Measured: Baseline through week 64( predose and postdose)

  15. Complement Alternative Pathway (AP) Functional Activity

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

    Measured: Baseline through week 64( predose and post dose)

  16. Complement FP

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

    Measured: Baseline through week 64(predose and postdose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start10 Feb 2026 (estimated)
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07387302
Sponsor's protocol ID
LIN2102-CN201
Status last verified
Jan 2026
First submitted
22 Jan 2026
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: It is not decided yet at this moment if we will share IPD with other researchers, or when will IPD will be shared, or with whom will IPD be shared, or by what mechanism will IPD be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SLN12140 in people with Paroxysmal Nocturnal Hemoglobinuria (PNH), run by Linno Pharmaceuticals, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hong Yan Tong, Professor (86+13958122357, hongyantong@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07387302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

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