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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SPR001
Sponsored by
Spruce Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Adrenal Hyperplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Spruce Biosciences Clinical Site
  • Spruce Biosciences Clinical Site
  • Spruce Biosciences Clinical Site
  • Spruce Biosciences Clinical Site
  • Spruce Biosciences Clinical Site
  • Spruce Biosciences Clinical Site
  • Spruce Biosciences Clinical Site
  • Spruce Biosciences Clinical Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPR001

Arm Description

SPR001 at Dose A

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Change from baseline in androstenedione
Change from Baseline to Week 12 in androstenedione following dosing of SPR001 in subjects with CAH
Change from baseline in adrenocorticotropic hormone (ACTH)
Change from Baseline to Week 12 in ACTH following dosing of SPR001 in subjects with CAH

Full Information

First Posted
September 11, 2018
Last Updated
January 28, 2020
Sponsor
Spruce Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT03687242
Brief Title
Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia
Official Title
A 3-Month Phase 2 Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 6, 2018 (Actual)
Primary Completion Date
September 17, 2019 (Actual)
Study Completion Date
September 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spruce Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Adrenal Hyperplasia, CAH - Congenital Adrenal Hyperplasia, CAH - 21-Hydroxylase Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPR001
Arm Type
Experimental
Arm Description
SPR001 at Dose A
Intervention Type
Drug
Intervention Name(s)
SPR001
Intervention Description
Open label SPR001
Primary Outcome Measure Information:
Title
The incidence of treatment-emergent adverse events (safety and tolerability) in subjects with CAH
Description
Incidence of treatment-emergent adverse events including any serious adverse events, dose-limiting toxicities, and adverse events leading to discontinuation of study drug.
Time Frame
Over the course of 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in 17-hydroxyprogesterone (17-OHP)
Description
Change from Baseline to Week 12 in 17-OHP following dosing of SPR001 in subjects with CAH
Time Frame
Over the course of 12 weeks
Title
Change from baseline in androstenedione
Description
Change from Baseline to Week 12 in androstenedione following dosing of SPR001 in subjects with CAH
Time Frame
Over the course of 12 weeks
Title
Change from baseline in adrenocorticotropic hormone (ACTH)
Description
Change from Baseline to Week 12 in ACTH following dosing of SPR001 in subjects with CAH
Time Frame
Over the course of 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Huang, MD
Organizational Affiliation
Spruce Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Spruce Biosciences Clinical Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Spruce Biosciences Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Spruce Biosciences Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Spruce Biosciences Clinical Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Spruce Biosciences Clinical Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Spruce Biosciences Clinical Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Spruce Biosciences Clinical Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Spruce Biosciences Clinical Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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