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

NCT07387302 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: LIN2102-CN201
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Outcome Measures

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

  12weeks after baseline

Secondary Outcomes (16)

• Percentage change of LDH from baseline

  Baseline through Week 64

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

  Baseline through Week 64

• Change in hemoglobin (Hb) levels from baseline

  Baseline through week 64

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

  Baseline through Week 64

• Proportion of participants who avoided blood transfusion

  Baseline through Week 64

Study Arms (1)

SLN 12140 will be administered subcutaneously .

EXPERIMENTAL

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

Interventions

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

SLN 12140 will be administered subcutaneously .

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Linno Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

Central Study Contacts

Hong Yan Tong, Professor

CONTACT

86+13958122357; hongyantong@aliyun.com

Feng Kui Zhang, Professor

CONTACT

86+; fkzhang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 4, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01