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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03687242
Recruitment Status : Active, not recruiting
First Posted : September 27, 2018
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Spruce Biosciences

Tracking Information
First Submitted Date  ICMJE September 11, 2018
First Posted Date  ICMJE September 27, 2018
Last Update Posted Date June 26, 2019
Actual Study Start Date  ICMJE September 6, 2018
Estimated Primary Completion Date August 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
The incidence of treatment-emergent adverse events (safety and tolerability) in subjects with CAH [ Time Frame: Over the course of 12 weeks ]
Incidence of treatment-emergent adverse events including any serious adverse events, dose-limiting toxicities, and adverse events leading to discontinuation of study drug.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03687242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
  • Change from baseline in 17-hydroxyprogesterone (17-OHP) [ Time Frame: Over the course of 12 weeks ]
    Change from Baseline to Week 12 in 17-OHP following dosing of SPR001 in subjects with CAH
  • Change from baseline in androstenedione [ Time Frame: Over the course of 12 weeks ]
    Change from Baseline to Week 12 in androstenedione following dosing of SPR001 in subjects with CAH
  • Change from baseline in adrenocorticotropic hormone (ACTH) [ Time Frame: Over the course of 12 weeks ]
    Change from Baseline to Week 12 in ACTH following dosing of SPR001 in subjects with CAH
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia
Official Title  ICMJE A 3-Month Phase 2 Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Congenital Adrenal Hyperplasia
  • CAH - Congenital Adrenal Hyperplasia
  • CAH - 21-Hydroxylase Deficiency
Intervention  ICMJE Drug: SPR001
Open label SPR001
Study Arms  ICMJE Experimental: SPR001
SPR001 at Dose A
Intervention: Drug: SPR001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 25, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 6, 2019
Estimated Primary Completion Date August 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03687242
Other Study ID Numbers  ICMJE SPR001-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Spruce Biosciences
Study Sponsor  ICMJE Spruce Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Huang, MD Spruce Biosciences
PRS Account Spruce Biosciences
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP