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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03687242
• Date of registration: 11/09/2018
• Prospective Registration: No
• Primary sponsor: Spruce Biosciences
• Public title: Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia
• Scientific title: A 3-Month Phase 2 Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia
• Date of first enrolment: September 6, 2018
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03687242
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Michael Huang, MD
• Affiliation: Spruce Biosciences

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

CAH - Congenital Adrenal Hyperplasia

Congenital Adrenal Hyperplasia

CAH - 21-Hydroxylase Deficiency

Intervention(s)

Drug: SPR001

Primary Outcome(s)

The incidence of treatment-emergent adverse events (safety and tolerability) in subjects with CAH [Time Frame: Over the course of 12 weeks]

Secondary Outcome(s)

Change from baseline in 17-hydroxyprogesterone (17-OHP) [Time Frame: Over the course of 12 weeks]

Change from baseline in androstenedione [Time Frame: Over the course of 12 weeks]

Change from baseline in adrenocorticotropic hormone (ACTH) [Time Frame: Over the course of 12 weeks]

Secondary ID(s)

SPR001-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors