"SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor "

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sparrow Pharmaceuticals Inc., Sparrow 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

completed 14 Feb 2025

Decision date (initial)

2024-10-07

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-516785-12-00

EudraCT number

2022-000748-32

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To study the benefit-risk of SPI-62 in participants with complications due to hypercortisolism related to autolomous cortisol secretion (ACS) in patients managed under standard of care

Secondary objectives 3

1. short-term progression, persistence, improvement, or resolution of clinical signs, markers, and symptom of hypercortisolism including: hyperglycemia, dyslipidemia, osteopenia, hypertension, and other features associated with endogenous hypercortisolism.
2. long-term safety as it relates to serious morbidity and mortality.
3. To study the efficacy of SPI-62 in reducing morbidity and mortality related to hypercortisolism.

Conditions and MedDRA coding

Hypercortisolism related to benign adrenal tumour

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. •Adult participants able to give informed consent and willing to adhere to necessary reproductive precautions.
2. •Participants with benign adrenal lesions(s) with proven ACS (clinical evidence of ACS confirmed by positive diagnostic tests per current guidelines).
3. • Participants should have documentation of treatment for, or evidence of, ongoing metabolic consequences for at least one of the following: hyperglycemia, hypertension, hyperlipidemia, osteopenia, attributable to clinically significant hypercortisolism.
4. • Surgery as first-line therapy should be discussed with all eligible participants, who will be included only if they have failed or rejected available surgical or medical therapy(ies) approved in their region of residence.

Exclusion criteria 11

1. • Participants with adrenal Cushing’s syndrome (aCs) will be excluded.
2. • History of adrenalectomy or planned adrenalectomy within 4 months after enrollment.
3. • Hypercortisolism which is exogenous including ACTH-dependent, cyclical, intermittent, or physiological (a.k.a. pseudo-Cushing’s).
4. • Participants who plan to undergo curative adrenal surgery within the next 3 years.
5. • History of idiopathic thrombocytopenia.
6. • History of cancer within 3 years likely to require further testing or intervention during the trial period or associate with a poor prognosis (e.g., other than treatable skin, thyroid, or early-stage prostate cancer, please consult with Medical Monitor for others).
7. • Any major surgery, or significant post-operative sequelae, within 1 month prior to informed consent or planned during the trial.
8. • Pregnant or lactating.
9. • Other medical contraindications to SPI-62 therapy or other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results.
10. • Participation in any clinical trial within 3 months prior to the first dose of study drug, or longer depending on half-life of the investigational therapy.
11. • Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a sanitary or social institution for purposes other than research and major persons subject to a legal protection measure.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. "an evaluation of the benefit-risk profile of SPI-62 consisting of laboratory data, incidence of treatment emergent adverse events (TEAEs), progression, or regression, of underlying disease or its complications"

Secondary endpoints 1

1. "short-term progression, persistence, improvement, or resolution of clinical signs, markers, and symptom of hypercortisolism including: hyperglycemia, dyslipidemia, osteopenia, hypertension, and other features associated with endogenous hypercortisolism. Long-term safety relating to serious morbidity or mortality"

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sparrow Pharmaceuticals Inc.

Sponsor organisation

Sparrow Pharmaceuticals Inc.

Address

920 Southwest 6th Avenue

City

Portland

Postcode

97204-1239

Country

United States

Scientific contact point

Organisation

Sparrow Pharmaceuticals Inc.

Contact name

Frank Czerwiec

Public contact point

Organisation

Sparrow Pharmaceuticals Inc.

Contact name

Jamie Macpherson

Third parties 3

Sparrow Pharmaceuticals Inc.

Sponsor organisation

Sparrow Pharmaceuticals Inc.

Address

920 Southwest 6th Avenue

City

Portland

Postcode

97204-1239

Country

United States

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

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

Documents 4 files

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

Application history

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