A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation

Conditions

• Antibody Mediated Rejection of Lung Transplant

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Siltuximab — DRUG
  Interleukin-6 blockade
• Placebo — DRUG
  Siltuximab placebo IV

Study Details

Antibody-mediated rejection after lung transplantation commonly results in allograft failure and death in spite of current therapeutic regimens. We are testing the safety and tolerability of the addition of a novel immunosuppressive medication to routine treatment for antibody-mediated rejection. Future studies will be needed to assess efficacy if this study demonstrates safety

Key Dates

Start date

Nov 6, 2025

Status verified

Dec 2025

Primary completion

Dec 30, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Siltuximab full-dose (11mg/kg) IV
  Siltuximab 11mg/kg IV on Days 1 and 22
• Experimental: Siltuximab half-dose (5.5mg/kg) IV
  Siltuximab 5.5 mg/kg IV on Days 1 and 22
• Placebo Comparator: Placebo IV
  Placebo IV on Days 1 and 22

Primary Outcome Measure

Incidence of CTCAE ≥ grade 3 [ Time Frame: From Randomization to Day 90. ]

Locations (2)

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