This is a Phase 2 study of SPR001 for the treatment of classic CAH that will provide 12 weeks of open-label treatment to eligible subjects.
This is a Phase 2 study of SPR001 for the treatment of classic CAH that will provide 12 weeks of open-label treatment to eligible subjects. To be eligible for this study, an individual must either have completed Study SPR001-201 or meet eligibility criteria for SPR001-naïve subjects. The expected duration of study participation for each subject is up to approximately 5 months. This includes a screening period of ≤30 days, a treatment period of 12 weeks, and a safety follow-up period of 30 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Open label SPR001
Spruce Biosciences Clinical Site
Orange, California, United States
Spruce Biosciences Clinical Site
San Diego, California, United States
Spruce Biosciences Clinical Site
Atlanta, Georgia, United States
Spruce Biosciences Clinical Site
The Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) in Subjects With CAH
Incidence of treatment-emergent adverse events including any serious adverse events, dose-limiting toxicities, and adverse events leading to discontinuation of study drug.
Time frame: Over 12 weeks
Change From Baseline in 17-hydroxyprogesterone (17-OHP)
Change from Baseline to Week 12 in 17-OHP following dosing of SPR001 in subjects with CAH. 17-OHP is measured in patient serum sample. Results are expressed as mean percent change from baseline. Reductions in 17-OHP are indicators of better disease control.
Time frame: Week 12
Change From Baseline in Androstenedione (A4)
Change from Baseline to Week 12 in androstenedione (A4) following dosing of SPR001 in subjects with CAH. A4 is measured in patient serum. Results are expressed as mean percent change from baseline. Reductions in A4 are indicators of better disease control.
Time frame: Week 12
Change From Baseline in Adrenocorticotropic Hormone (ACTH)
Change from Baseline to Week 12 in adrenocorticotropic hormone (ACTH) following dosing of SPR001 in subjects with CAH. ACTH is measured in patient serum. Results are expressed as mean percent change from baseline. Reductions in ACTH are indicators of better disease control.
Time frame: Week 12
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Indianapolis, Indiana, United States
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Las Vegas, Nevada, United States
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Philadelphia, Pennsylvania, United States