An open label, long-term extension study to evaluate the safety and efficacy of CRN00808 in subjects with acromegaly (ACROBAT ADVANCE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Crinetics Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

Trial duration

19 Feb 2020 → 5 Mar 2026

Decision date (initial)

2024-07-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Crinetics Pharmaceuticals, Inc. United States

External identifiers

EU CT number

2024-511921-75-00

EudraCT number

2019-002193-31

ClinicalTrials.gov

NCT04261712

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Therapy

This study is designed to evaluate the long-term safety and tolerability of paltusotine in acromegaly subjects; to evaluate the efficacy of paltusotine in acromegaly patients.

Conditions and MedDRA coding

Acromegaly

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-002682-PIP01-19

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 1. Completed one of the parent studies (Acrobat Evolve (CRN00808-02) or Acrobat Edge (CRN00808-03))
2. 2. Females must be non-pregnant and non-lactating either surgically sterile, post-menopausal, or using effective method(s) of birth control.
3. 3. Willing to provide signed informed consent

Exclusion criteria 10

1. 1. Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
2. 2. Pituitary radiation since completing participation in parent studies
3. 3. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 year
4. 4. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
5. 5. History of alcohol or substance abuse in the past 12 months
6. 6. Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening
7. 7. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
8. 8. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
9. 9. Subjects with symptomatic cholelithiasis
10. 10. Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. The primary endpoint is the incidence of treatment-emergent AEs (TEAEs) throughout the study.

Secondary endpoints 2

1. 1. Change from the W16 visit (15 weeks of study treatment) in IGF-1 levels
2. 2. Change from W16 in growth hormone (GH) levels;

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Crinetics Pharmaceuticals Inc.

Sponsor organisation

Crinetics Pharmaceuticals Inc.

Address

6055 Lusk Boulevard

City

San Diego

Postcode

92121-2700

Country

United States

Scientific contact point

Organisation

Crinetics Pharmaceuticals Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Crinetics Pharmaceuticals Inc.

Contact name

Clinical Medical Lead

Third parties 11

Sponsor responsibilities

Article 77 compliance

Crinetics Pharmaceuticals Inc.

Article 77 implementation

Crinetics Pharmaceuticals Inc.

Locations

3 EU/EEA countries · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 25 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications