A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503770-21-00

Acronym

SPR001-203

Enrollment

Registered

2023-04-25

Start date

2021-01-05

Completion date

2024-03-24

Last updated

2024-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Classic Congenital Adrenal Hyperplasia

Brief summary

Percent change from baseline in androstenedione after 12 weeks on treatment (Week 18).

Detailed description

1. Proportion of subjects who achieve androstenedione ≤ upper limit of normal after 12 weeks on treatment (Week 18), 2. Proportion of subjects who achieve 17-hydroxyprogesterone ≤ 1200 ng/dL after 12 weeks on treatment (Week 18)., 3. Change in the lesion volume of testicular adrenal rest tumor(s) from baseline after 12 weeks on treatment (Week 18)

Interventions

DRUGHydrocortisone

DRUGsame as IMP (Tildacerfont) minus active substance

DRUGTildacerfont

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in androstenedione after 12 weeks on treatment (Week 18).	—

Secondary

Measure	Time frame
1. Proportion of subjects who achieve androstenedione ≤ upper limit of normal after 12 weeks on treatment (Week 18), 2. Proportion of subjects who achieve 17-hydroxyprogesterone ≤ 1200 ng/dL after 12 weeks on treatment (Week 18)., 3. Change in the lesion volume of testicular adrenal rest tumor(s) from baseline after 12 weeks on treatment (Week 18)	—

Countries

Denmark, Estonia, Germany, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026