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NCT03687242 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Congenital Adrenal Hyperplasia and CAH - Congenital Adrenal Hyperplasia, sponsored by Spruce Biosciences.

Completed
Registry status
Phase 2
Development phase
11
Enrollment target
8
Study locations

NCT03687242: Completed Phase 2 study of Congenital Adrenal Hyperplasia and CAH - Congenital Adrenal Hyperplasia, sponsored by Spruce Biosciences.

NCT03687242 is a Phase 2 study of Congenital Adrenal Hyperplasia and CAH - Congenital Adrenal Hyperplasia that has completed, run by Spruce Biosciences. The registered enrollment target is 11 participants, below the 101-participant average among 8 other Congenital Adrenal Hyperplasia trials with a reported enrollment target (89% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03687242, a Phase 2 study of Congenital Adrenal Hyperplasia and CAH - Congenital Adrenal Hyperplasia, has completed, sponsored by Spruce Biosciences.

COMPLETED
Registry status
Phase 2
Development phase
11 participants
Enrollment target
8
Study locations

Study 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.

Primary Outcome

Incidence of treatment-emergent adverse events including any serious adverse events, dose-limiting toxicities, and adverse events leading to discontinuation of study drug.

Interventions

  • DRUG SPR001

Study Locations (8)

California

  • Spruce Biosciences Clinical Site - Orange
  • Spruce Biosciences Clinical Site - San Diego

Georgia

  • Spruce Biosciences Clinical Site - Atlanta

Indiana

  • Spruce Biosciences Clinical Site - Indianapolis

Michigan

  • Spruce Biosciences Clinical Site - Ann Arbor

Minnesota

  • Spruce Biosciences Clinical Site - Minneapolis

Nevada

  • Spruce Biosciences Clinical Site - Las Vegas

Pennsylvania

  • Spruce Biosciences Clinical Site - Philadelphia

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2018-09-06
Est. Completion 2019-08-09
Phase Phase 2
Spruce Biosciences

6 total trials

What the finished NCT03687242 record still lists

NCT03687242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 101-participant average among 8 other Congenital Adrenal Hyperplasia trials with a reported enrollment target (89% lower).

The record links to 3 conditions, with Congenital Adrenal Hyperplasia appearing as the primary indexed condition, and to 1 intervention - of which SPR001 is the first listed.

NCT03687242 lists 8 locations in 7 states (California, Georgia, Indiana).

Frequently Asked Questions

What is clinical trial NCT03687242 about?

NCT03687242 is a clinical study titled "Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia". 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.

What is the current status of trial NCT03687242?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2018-09-06. Estimated completion is 2019-08-09.

What conditions does trial NCT03687242 study?

This clinical trial studies the following conditions: Congenital Adrenal Hyperplasia, CAH - Congenital Adrenal Hyperplasia, CAH - 21-Hydroxylase Deficiency.

What interventions are being tested in trial NCT03687242?

The interventions under investigation include: SPR001 (DRUG).

Who is sponsoring clinical trial NCT03687242?

This trial is sponsored by Spruce Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03687242 being conducted?

This trial has 8 study locations across California, Georgia, Indiana, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Congenital Adrenal Hyperplasia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03687242's enrollment target sits among peer trials

11 8th of 8 higher than 1 of 8 other Congenital Adrenal Hyperplasia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Congenital Adrenal Hyperplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03687242, the US trial registry maintained by the National Library of Medicine. NCT03687242 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.