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About
Phase 2, open-label, extension study to evaluate the long-term safety, clinical activity, and pharmacodynamics of briquilimab in participants previously enrolled in a Jasper sponsored CU clinical trial.
Full description
This is a Phase 2, open-label, extension study to evaluate the long-term safety, clinical activity, and pharmacodynamics of briquilimab in participants previously enrolled in a Jasper sponsored CU clinical trial, specifically the BEACON (JSP-CP-011) and SPOTLIGHT (JSP CP-010) trials (referred to as "parent studies") and future CU trials sponsored by Jasper Therapeutics.
Enrollment
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Volunteers
Inclusion criteria
Provides informed written consent.
Previously participated in and completed an eligible Jasper-sponsored clinical trial (in the last 4 months) without any investigational product (IP)-related anaphylactic event
Disease specific eligibility:
The laboratory parameters to be within the acceptable range as follows:
Participants willing to abstain from blood donations while being on the trial (Screening to end of trial [EOT]).
Male participants (who are not vasectomized) who are heterosexually active must use highly effective contraceptive methods and must abstain from sperm donation during the trial and for at least 8 months after the last dose of briquilimab. A male participant is considered vasectomized if he had a vasectomy at least 4 months prior to Screening and if he has received post-surgical medical assessment of the surgical success of the vasectomy
Female participants of childbearing potential who are heterosexually active (defined in Section 5.2.1.1) must use highly effective contraceptive methods (Section 5.2.1) during the trial and for at least 90 days after the last dose of briquilimab. Female participants of non-childbearing potential must be surgically sterile (i.e., had undergone complete hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or be in a menopausal state (at least 1 year without menses).
Exclusion criteria
Primary purpose
Allocation
Interventional model
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90 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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