Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia
Status: | Recruiting |
---|---|
Conditions: | Endocrine, Hematology |
Therapuetic Areas: | Endocrinology, Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/29/2018 |
Start Date: | September 6, 2018 |
End Date: | July 3, 2019 |
Contact: | Kelly Vandever |
Email: | kvandever@sprucebiosciences.com |
Phone: | 6194177546 |
A 3-Month Phase 2 Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia
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.
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.
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.
Inclusion Criteria:
- Is approved by the Sponsor's Medical Monitor
- Is on a stable regimen of glucocorticoid replacement for ≥30 days before baseline that
is expected to remain stable throughout the study
- If screening for this study occurs >3 months after the subject's final follow-up visit
in Study SPR001-201, the subject will have serum 17-OHP measured at screening.
- Agrees to follow contraception guidelines
- Is able to understand all study procedures and risks involved and provides written
informed consent indicating willingness to comply with all aspects of the protocol
Exclusion Criteria:
- Experienced a clinically significant AE considered at least possibly related to SPR001
in Study SPR001-201
- If screening for this study occurs >3 months after the subject's final follow-up visit
in Study SPR001-201, the subject will be screened for any clinically significant
unstable medical condition, medically significant illness, or chronic disease
occurring within 30 days of screening
- Is at increased risk of suicide
- Clinically significant depression or anxiety at screening or baseline
- Clinically significant abnormal clinical or laboratory assessments must be discussed
with the Medical Monitor to determine eligibility for this study.
- Subjects who routinely work overnight shifts require Medical Monitor approval for
enrollment
- Females who are pregnant or lactating
- Use of any other investigational drug within 30 days or 5 half-lives before screening
- Use of prohibited concomitant medications (including rosiglitazone, testosterone, and
strong inhibitors and/or inducers of CYP3A4) within 30 days or 5 half-lives of
baseline. Medications metabolized by CYP3A4, 2C8, 2C9, or 2C19, especially those that
are sensitive substrates or substrates with narrow therapeutic ranges should be
discussed on a case-by-case basis with the Medical Monitor.
We found this trial at
9
sites
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