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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

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.

Condition or disease Intervention/treatment Phase
Congenital Adrenal Hyperplasia CAH - Congenital Adrenal Hyperplasia CAH - 21-Hydroxylase Deficiency Drug: SPR001 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 3-Month Phase 2 Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia
Actual Study Start Date : September 6, 2018
Estimated Primary Completion Date : August 19, 2019
Estimated Study Completion Date : September 6, 2019


Arm Intervention/treatment
Experimental: SPR001
SPR001 at Dose A
Drug: SPR001
Open label SPR001




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687242


Locations
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United States, California
Spruce Biosciences Clinical Site
Orange, California, United States, 92868
Spruce Biosciences Clinical Site
San Diego, California, United States, 92123
United States, Georgia
Spruce Biosciences Clinical Site
Atlanta, Georgia, United States, 30046
United States, Indiana
Spruce Biosciences Clinical Site
Indianapolis, Indiana, United States, 46202
United States, Michigan
Spruce Biosciences Clinical Site
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Spruce Biosciences Clinical Site
Minneapolis, Minnesota, United States, 55414
United States, Nevada
Spruce Biosciences Clinical Site
Las Vegas, Nevada, United States, 89148
United States, Pennsylvania
Spruce Biosciences Clinical Site
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Spruce Biosciences
Investigators
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Study Director: Michael Huang, MD Spruce Biosciences

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Responsible Party: Spruce Biosciences
ClinicalTrials.gov Identifier: NCT03687242     History of Changes
Other Study ID Numbers: SPR001-202
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperplasia
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders