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SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome (RESCUE)

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ClinicalTrials.gov Identifier: NCT05307328
Recruitment Status : Recruiting
First Posted : April 1, 2022
Last Update Posted : September 23, 2022
Sponsor:
Information provided by (Responsible Party):
Sparrow Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 23, 2022
First Posted Date  ICMJE April 1, 2022
Last Update Posted Date September 23, 2022
Actual Study Start Date  ICMJE March 1, 2022
Estimated Primary Completion Date March 15, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2022)
Change from baseline in urinary HSD-1 ratio [ Time Frame: Baseline to 6 weeks ]
The urinary HSD-1 ratio (tetrahydrocortisol + allotetrahydrocortisol ) / tetrahydrocortisone will be used as a biomarker of HSD-1 activity in liver. The primary analysis will include only subjects with Cushing's disease.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2022)
Treatment emergent adverse events [ Time Frame: Baseline through 24 weeks of treatment ]
Adverse events including clinically significant abnormal values on clinical laboratory evaluations, continuous glucose monitoring (CGM), 12-lead ECGs, vital signs measurements (including orthostatic vital sign measurements), physical examinations, and HPA and HPG axis biomarkers
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 SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome
Official Title  ICMJE SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome
Brief Summary This is a randomized, placebo-controlled, crossover study of SPI-62 in subjects with ACTH-dependent Cushing's syndrome. Subjects will receive each of the following 2 treatments for 12 weeks: SPI-62 and matching placebo
Detailed Description This is a multicenter, randomized, placebo-controlled, Phase 2 study to evaluate the pharmacologic effect, efficacy, and safety of SPI-62 in subjects with ACTH-dependent Cushing's syndrome. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in 3 periods: a 28-day screening period (Days -35 to -8), a 7-day baseline period (Days -7 to -1), and a 24-week treatment period (Day 1 of Week 1 to Day 168 ± 3 days of Week 24). Up to 26 subjects will be enrolled with the aim that 18 subjects with Cushing's disease will complete the study. Subjects will receive each of the following 2 treatments for 12 weeks: SPI-62 and matching placebo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Staggered parallel crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cushing's Syndrome I
  • Cushing Disease Due to Increased ACTH Secretion
  • Cortisol Excess
  • Cortisol; Hypersecretion
  • Cortisol Overproduction
  • Ectopic ACTH Secretion
Intervention  ICMJE
  • Drug: SPI-62
    11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor
  • Drug: Placebo
    Inactive tablets identical to SPI-62 tablets
Study Arms  ICMJE
  • Experimental: SPI-62
    Active drug by mouth each morning for up to 12 weeks
    Interventions:
    • Drug: SPI-62
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo by mouth each morning for up to 12 weeks
    Interventions:
    • Drug: SPI-62
    • Drug: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2022)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2023
Estimated Primary Completion Date March 15, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or non-menstruating female
  • 18 years or older
  • Active and consistent cortisol excess
  • Documented diagnosis of ACTH-dependent Cushing's syndrome including Cushing's disease, ectopic ACTH secretion, and ectopic CRH secretion.

Exclusion Criteria:

  • Recent (within 6 weeks) surgery for Cushing's or surgery planned within 24 weeks of randomization.
  • History of any fractionated radiation therapy for Cushing's within the past 2 years or conventional radiation therapy within 4 years.
  • History of bilateral adrenalectomy or exogenous, pseudo, cyclic, or non-ACTH-dependent Cushing's syndrome (including certain inherited conditions).
  • High risk of acute morbidity from corticotroph adenoma growth (similar to that which occurs with Nelson's syndrome) defined as current evidence of macroadenoma at risk of impingement of vital structures.
  • Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results, including but not limited to poor venous access or recent receipt or donation of blood products.
  • Women who are currently pregnant, lactating or planning fertility and unwilling to adhere to approved contraceptives or abstinence.
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: Frank Czerwiec, MD +1-617-465-0328 fczerwiec@sparrowpharma.com
Contact: Sarah Hooper +1-617-465-0328 shooper@sparrowpharma.com
Listed Location Countries  ICMJE Bulgaria,   Romania,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05307328
Other Study ID Numbers  ICMJE SPI-62-CL-2001
Has Data Monitoring Committee Yes
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 Not Provided
Current Responsible Party Sparrow Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sparrow Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Frank Czerwiec, MD Sparrow Pharmaceuticals (info@sparrowpharma.com)
PRS Account Sparrow Pharmaceuticals
Verification Date September 2022

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