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

NCT ID: NCT03687242

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-06
• Study Completion Date: 2019-08-09

Brief 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.

Detailed 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.

Conditions

Congenital Adrenal Hyperplasia; CAH - Congenital Adrenal Hyperplasia; CAH - 21-Hydroxylase Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SPR001

SPR001 at Dose A

Group Type: EXPERIMENTAL

SPR001

Intervention Type: DRUG

Open label SPR001

Interventions

SPR001

Open label SPR001

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spruce Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

Spruce Biosciences

Locations

Spruce Biosciences Clinical Site

Orange, California, United States

Spruce Biosciences Clinical Site

San Diego, California, United States

Spruce Biosciences Clinical Site

Atlanta, Georgia, United States

Spruce Biosciences Clinical Site

Indianapolis, Indiana, United States

Spruce Biosciences Clinical Site

Ann Arbor, Michigan, United States

Spruce Biosciences Clinical Site

Minneapolis, Minnesota, United States

Spruce Biosciences Clinical Site

Las Vegas, Nevada, United States

Spruce Biosciences Clinical Site

Philadelphia, Pennsylvania, United States

Countries

United States

References

Sarafoglou K, Barnes CN, Huang M, Imel EA, Madu IJ, Merke DP, Moriarty D, Nakhle S, Newfield RS, Vogiatzi MG, Auchus RJ. Tildacerfont in Adults With Classic Congenital Adrenal Hyperplasia: Results from Two Phase 2 Studies. J Clin Endocrinol Metab. 2021 Oct 21;106(11):e4666-e4679. doi: 10.1210/clinem/dgab438.

Reference Type: RESULT

PMID: 34146101 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SPR001-202

Identifier Type: -

Identifier Source: org_study_id