Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal H… (NCT03687242) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia
United States11 participantsStarted 2018-09-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pro…
What they're measuring
1
The Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) in Subjects With CAH