Long-term Safety and Efficacy of TQH2722 Injection in the Treatment of Chronic Sinusitis With or … (NCT06439381) | Clinical Trial Compass
RecruitingPhase 2
Long-term Safety and Efficacy of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps
China120 participantsStarted 2024-07-16
Plain-language summary
This is a multicenter, randomized, continuing, Phase II expansion trial to evaluate the safety, efficacy, and immunogenicity of two doses of TQH2722 in the long-term treatment of severe chronic sinusitis with or without nasal polyps.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Inclusion Criteria of Part A
✓. Subjects completed prescribed treatment as required and completed Part A end of study (EOS) visit;
✓. The subjects withdrew early due to poor compliance or other objective reasons other than TQH2722-related AE, and completed the early exit interview according to the plan, and the influencing factors that led to the subjects' early termination of the main study treatment have disappeared/no longer affected the subjects' participation in the continuation study as assessed by the investigators and sponsors.
✓. Inclusion Criteria of Part B
✓. Subjects completed prescribed treatment as required and completed Part B EOS visit;
✓. The subjects withdrew early due to poor compliance or other objective reasons other than TQH2722-related AE, and completed the early exit interview according to the plan, and the influencing factors that led to the subjects' early termination of the main study treatment have disappeared/no longer affected the subjects' participation in the continuation study as assessed by the investigators and sponsors.
Exclusion criteria
✕. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 upper limit of normal (ULN);
✕. Total bilirubin \> 2 x ULN (except indirect bilirubin elevation secondary to Gilbert syndrome);
✕. Creatinine \> 1.5×ULN;
✕. Had sinus surgery or nasal sinus surgery within 6 months prior to screening (visit 1).
What they're measuring
1
Treatment emergent adverse events (TEAE)
Timeframe: Up to 32 weeks
Trial details
NCT IDNCT06439381
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
✕. Received monoclonal antibody therapy within 8 weeks or 5 half-lives prior to screening (whichever is longer);
✕. Received immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporine, interferon gamma, azathioprine, methotrexate, mycophenolate and tacrolimus) within 8 weeks or 5 half-lives prior to screening, whichever is longer;
✕. Use of other non-biological agents within 8 weeks or 5 half-lives (whichever is longer) prior to screening;
✕. Intravenous immunoglobulin (IVIG) therapy and/or plasma exchange within 30 days prior to screening visit (Visit 1);