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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)
• Intervention / Treatment: Drug: SLN12140

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hong Yan Tong, Professor; Phone Number: 86+13958122357; Email: hongyantong@aliyun.com
• Study Contact Backup: Name: Feng Kui Zhang, Professor; Phone Number: 13821700281 86+; Email: fkzhang@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SLN 12140 will be administered subcutaneously .; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12weeks after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change of LDH from baseline	To assess the efficacy of SLN12140 in participants with PNH	Baseline through Week 64
Proportion of participants achieving hemolysis control (LDH ≤ 1.5×ULN)	To assess the efficacy of SLN12140 in participants with PNH	Baseline through Week 64
Change in hemoglobin (Hb) levels from baseline	To assess the efficacy of SLN12140 in participants with PNH	Baseline through week 64
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	Baseline through Week 64
Proportion of participants who avoided blood transfusion	To assess the efficacy of SLN12140 in participants with PNH	Baseline through Week 64
Incidence(%) of Breakthrough Hemolysis (BTH)	To assess the efficacy of SLN12140 in participants with PNH	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.)	To assess the efficacy of SLN12140 in participants with PNH	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.);	To assess the efficacy of SLN12140 in participants with PNH	Baseline through week 64
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.	Baseline through Week 64
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	Baseline through Week 64
Pharmacokinetics (PK)parameters of SLN12140: Area Under The Plasma Concentration-time Curve	To characterize the pharmacokinetics of SLN12140 in participants with PNH	Baseline through week 64 (predose and postdose)
Immunegenicity in Paraxysmal Nocturnal Hemoglobinuria	Determine anti-drug antibody titers	Baseline through Week 64
PK: Maximum Plasma Concentration (Cmax)	To characterize the pharmacokinetics of SLN12140 in participants with PNH	Baseline through week 64( predose and postdose)
PK: Time To Maximum Concentration (Tmax)	To characterize the pharmacokinetics of SLN12140 in participants with PNH	Baseline through week 64( predose and postdose)
Complement Alternative Pathway (AP) Functional Activity	Serum AP functional activity was measured by the Wieslab functional immunoassay method.	Baseline through week 64( predose and post dose)
Complement FP	Plasma FP was measured by enzyme-linked immunosorbent assay (ELISA).	Baseline through week 64(predose and postdose)

Collaborators and Investigators

• Sponsor: Linno Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Anemia, Hemolytic; Anemia; Myelodysplastic Syndromes; Hemic and Lymphatic Diseases; Hemoglobinuria, Paroxysmal
• Other Study ID Numbers: LIN2102-CN201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No