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

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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.

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.

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
Atlanta, Georgia 30046
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Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Bethesda, Maryland 20892
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Bethesda, MD
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Las Vegas, Nevada 89148
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Las Vegas, NV
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Minneapolis, Minnesota 55414
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Minneapolis, MN
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Orange, California 92123
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Orange, CA
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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San Diego, California 92123
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San Diego, CA
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