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Trial · NCT07906145

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySafety and Tolerability of QLS2416 InjectionUp to 24 weeksIncidence and severity of treatment-emergent adverse events.
SecondaryPharmacokinetic Profile of QLS2416Up to 24 weeksPeak Plasma Concertration(Cmax)
SecondaryPharmacokinetic Profile of QLS2416Up to 24 weeksTime to maximum plasma concentration(Tmax)
SecondaryPharmacokinetic Profile of QLS2416Up to 24 weeksElimination half-life (t1/2)
SecondaryAnti-Drug AntibodyUp to 24 weeksIncidence of anti-QLS2416 antibodies (ADA)
SecondarySLE Responder Index (SRI) and Other SLE Disease Activity MeasuresUp to 24 weeksPercentage of participants achieving SRI (4)
SecondarySLE Responder Index (SRI) and Other SLE Disease Activity MeasuresUp to 24 weeksPercentage of participants achieving Definitions Of Remission In Systemic Lupus Erythematosus remission(DORIS remission)
SecondarySLE Responder Index (SRI) and Other SLE Disease Activity MeasuresUp to 24 weeksPercentage of participants achieving Lupus Low Disease Activity State(LLDAS)
SecondaryRA Disease Activity MeasuresUp to 24 weeksChanges in Disease Activity Score in 28 Joints - C-reactive Protein (DAS28-CRP).
SecondarypSS Disease Activity MeasuresUp to 24 weeksChanges in Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (clinESSDAI).
SecondarySSc Disease Activity MeasuresUp to 52 weeksChanges in modified Rodnan skin score (mRSS).
SecondarySSc Disease Activity MeasuresUp to 52 weeksChanges in Combined Response Index for Systemic Sclerosis(CRISS).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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