Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia

Spruce Biosciences

Status and phase

Completed

Phase 2

Conditions

CAH - Congenital Adrenal Hyperplasia

CAH - 21-Hydroxylase Deficiency

Congenital Adrenal Hyperplasia

Treatments

Drug: SPR001

Study type

Interventional

Funder types

Industry

Identifiers

NCT03687242

SPR001-202

Details and patient eligibility

About

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.

Full description

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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.