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

Congenital Adrenal Hyperplasia Clinical Trial

Official title:

A 3-Month Phase 2 Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687242
• Other study ID #: SPR001-202
• Status: Completed
• Phase: Phase 2
• Start date: September 6, 2018
• Est. completion date: September 24, 2019

Study information

• Verified date: June 2019
• Source: Spruce Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 24, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adrenal Hyperplasia, Congenital
• Adrenocortical Hyperfunction
• Adrenogenital Syndrome
• CAH - 21-Hydroxylase Deficiency
• CAH - Congenital Adrenal Hyperplasia
• Congenital Adrenal Hyperplasia
• Hyperplasia

Intervention

Drug:
• SPR001
Open label SPR001

Locations

Country	Name	City	State
United States	Spruce Biosciences Clinical Site	Ann Arbor	Michigan
United States	Spruce Biosciences Clinical Site	Atlanta	Georgia
United States	Spruce Biosciences Clinical Site	Indianapolis	Indiana
United States	Spruce Biosciences Clinical Site	Las Vegas	Nevada
United States	Spruce Biosciences Clinical Site	Minneapolis	Minnesota
United States	Spruce Biosciences Clinical Site	Orange	California
United States	Spruce Biosciences Clinical Site	Philadelphia	Pennsylvania
United States	Spruce Biosciences Clinical Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Spruce Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of treatment-emergent adverse events (safety and tolerability) in subjects with CAH	Incidence of treatment-emergent adverse events including any serious adverse events, dose-limiting toxicities, and adverse events leading to discontinuation of study drug.	Over the course of 12 weeks
Secondary	Change from baseline in 17-hydroxyprogesterone (17-OHP)	Change from Baseline to Week 12 in 17-OHP following dosing of SPR001 in subjects with CAH	Over the course of 12 weeks
Secondary	Change from baseline in androstenedione	Change from Baseline to Week 12 in androstenedione following dosing of SPR001 in subjects with CAH	Over the course of 12 weeks
Secondary	Change from baseline in adrenocorticotropic hormone (ACTH)	Change from Baseline to Week 12 in ACTH following dosing of SPR001 in subjects with CAH	Over the course of 12 weeks