ACROBAT EDGE
Research type
Research Study
Full title
An open label exploratory study to evaluate the safety, pharmacokinetics and efficacy of CRN00808 in patients with acromegaly treated with somatostatin analogue based treatment regimens (ACROBAT EDGE)
IRAS ID
254340
Contact name
Marta Korbonits
Contact email
Sponsor organisation
Crinetics Pharmaceuticals, Inc.
Eudract number
2018-002230-20
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
Acromegaly is a hormonal disorder that results from too much growth hormone (GH) in the body which can lead to a wide range of cardiovascular, respiratory, endocrine and metabolic illnesses, as well as joint pain, weakness and sometimes visual disturbances. The investigational product CRN00808 may normalize hormone levels in acromegaly patients and may improve patient compliance and quality of life by eliminating painful injections and reduce the need for frequent physician office visits. Additionally, it potentially allows physicians to quickly determine a dosing regimen for superior outcomes compared to existing therapies.
The purpose of ACROBAT EDGE study is to see if CRN00808 is effective, tolerable and safe in controlling the growth hormone levels of patients with acromegaly treated with somatostatin analogue (SSA) based treatment regimens. The primary objective of the study is to assess the efficacy of CRN00808 in subjects who are partial responders to SSA based treatment regimens.
After an initial period to determine eligibility for the study of between 4 and 6 weeks (Screening Period), all subjects will receive study treatment (up to 13 weeks) with CRN00808 beginning with a 10 mg dose. At certain time points, depending on the response to study treatment, the dose may be either raised or lowered. The maximum dose strength for this study will be 40 mg. All subjects in the study whose acromegaly continues to respond to CRN00808, will continue on study treatment for a total of 13 weeks. During this period, neither subject, nor study doctor will be aware of dose of treatment. All subjects will be removed from acromegaly treatment during a 4-week Follow-up Period.
Approximately 45 male and female subjects (18-70 years old) on stable doses of SSA based pharmacotherapy for the treatment of acromegaly will participate in this study which will be conducted at approximately 30 investigational sites in Europe and the USA.REC name
London - Central Research Ethics Committee
REC reference
18/LO/1993
Date of REC Opinion
8 Jan 2019
REC opinion
Further Information Favourable Opinion