Study of SPI-62 for Treating ACTH-Dependent Cushing’s Syndrome in Patients with Cushing’s Disease or Ectopic ACTH/CRH Secretion

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What is this study about?

This clinical trial is focused on studying a condition known as Cushing’s Syndrome, which is a disorder caused by high levels of the hormone cortisol in the body. The trial will specifically look at a type of Cushing’s Syndrome that depends on a hormone called adrenocorticotropic hormone (ACTH). This includes conditions like Cushing’s Disease, where the pituitary gland produces too much ACTH, and other forms where ACTH is produced outside the pituitary gland. The treatment being tested is a medication called SPI-62, which is a new type of drug designed to reduce the effects of cortisol by inhibiting an enzyme called 11β-hydroxysteroid dehydrogenase type 1 (HSD-1).

The purpose of the study is to understand how SPI-62 affects people with ACTH-dependent Cushing’s Syndrome. Participants in the study will take the medication in the form of a film-coated tablet, which is taken orally. The study will last for several weeks, during which participants will be monitored for changes in their condition. This includes measuring the levels of certain substances in their urine and blood to see how the medication is working. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active ingredient.

Throughout the study, participants will have regular check-ups to monitor their health and any side effects they might experience. The study will also look at how the medication affects other health issues related to Cushing’s Syndrome, such as blood sugar levels, cholesterol, blood pressure, and bone health. The trial aims to provide valuable information on the safety and effectiveness of SPI-62 as a treatment option for people with this condition.

1 joining the study

Upon joining the study, the participant will begin the trial for the treatment of adrenocorticotropic hormone-dependent Cushing’s syndrome using the medication SPI-62.

The trial aims to understand the effects of SPI-62 on the condition, focusing on specific hormone levels in the body.

2 medication administration

The medication, SPI-62, is administered in the form of a film-coated tablet.

The route of administration is oral use.

3 treatment duration

The treatment with SPI-62 will be conducted over a period of 12 weeks.

During this time, various assessments and measurements will be taken to monitor the effects of the medication.

4 primary assessment

The primary focus of the assessment is the urinary HSD-1 ratio at Week 6.

This ratio is a measure of specific hormone levels in the urine, which helps in evaluating the treatment’s effectiveness.

5 secondary assessments

Secondary assessments include monitoring for any adverse events, changes in laboratory evaluations, and other health indicators.

These assessments will be conducted at various points during the 12-week treatment period.

6 long-term monitoring

Participants may be monitored in an open-label extension phase for long-term safety and efficacy.

This phase will help gather additional data on the medication’s effects over an extended period.

Who Can Join the Study?

Must be a male or female aged 18 years or older.
Must be able to provide written informed consent, which means agreeing to participate after understanding the study details.
Must have active and consistent cortisol excess, which is a condition where the body produces too much cortisol, a hormone. This is confirmed by:
- Urinary free cortisol (UFC) levels higher than normal in at least 2 complete 24-hour urine samples.
- Non-suppressed morning serum cortisol level of at least 1.8 mcg/dL after an overnight dexamethasone suppression test.
- Late-night or bedtime salivary cortisol levels above normal.
Must have a documented diagnosis of ACTH-dependent Cushing’s syndrome, which includes:
- Cushing’s disease, ectopic ACTH secretion, or ectopic CRH secretion.
- Diagnosis can be supported by previous medical records showing:
  - Positive ACTH-staining pathology.
  - Temporary need for glucocorticoid replacement after tumor removal.
  - ACTH level greater than 20 pg/mL with a positive response to certain tests.
  - Specific test results showing ACTH levels in certain blood samples.
  - Presence of a pituitary tumor with specific test responses.
  - Other confirmed tests for ectopic ACTH-dependent Cushing’s syndrome.
Must be willing to follow reproductive precautions, meaning females should not be pregnant or breastfeeding, and both males and females must agree to use contraception.
Must have current evidence of Cushing’s related health issues, such as:
- Hyperglycemia (high blood sugar), dyslipidemia (abnormal cholesterol levels), hypertension (high blood pressure), or osteopenia (weaker bones).
- Specific criteria include:
  - Diagnosis of insulin resistance, pre-diabetes, or type 2 diabetes with certain blood sugar levels.
  - Diagnosis of dyslipidemia with specific cholesterol or triglyceride levels.
  - Diagnosis of hypertension with certain blood pressure readings.
  - Diagnosis of osteoporosis or osteopenia with specific bone density scores or history of fractures.

Who Cannot Join the Study?

Patients who do not have Cushing’s Syndrome cannot participate. Cushing’s Syndrome is a condition where the body has too much of a hormone called cortisol.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding cannot participate, as the study may not be safe for the baby.
Patients who are currently participating in another clinical trial cannot join this study.
Patients who have a history of drug or alcohol abuse that might interfere with the study cannot participate.
Patients who have allergies or reactions to the study medication or similar medications cannot participate.
Patients who have had recent surgery or are planning to have surgery during the study period cannot participate.
Patients who have certain abnormal lab test results that might affect the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
National Institute Of Endocrinology C.I. Parhon	Bucharest	Romania
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Mzhuhbs Ccoxuw Auaop Ixa Pohzaxo Esbi	Sofia	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	02.08.2024
Romania	Not recruiting	02.08.2024

Trial locations

Investigated drugs:

Clofutriben

SPI-62 is a medication being studied for its potential to treat Cushing’s syndrome that is dependent on adrenocorticotropic hormone (ACTH). This condition can include Cushing’s disease, ectopic ACTH secretion, and ectopic corticotrophin-releasing hormone (CRH) secretion. The trial aims to understand how SPI-62 affects the body, particularly by measuring changes in a specific enzyme activity in the urine.

Investigated diseases:

Pituitary-dependent Cushing's syndrome

Cushing’s Syndrome – Cushing’s Syndrome is a condition characterized by excessive levels of cortisol in the body. This can occur due to various reasons, including the overproduction of adrenocorticotropic hormone (ACTH) by the pituitary gland, known as Cushing’s disease, or from ectopic sources of ACTH or corticotrophin-releasing hormone (CRH). The syndrome leads to symptoms such as weight gain, particularly around the abdomen and face, thinning skin, and high blood pressure. Over time, it can also cause muscle weakness, bone loss, and changes in mood or cognition. The progression of the disease depends on the underlying cause and the levels of cortisol present in the body.

Trial ID:

2024-515913-17-00

Protocol code:

SPI-62-CL-2001

NCT ID:

NCT05307328

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of SPI-62 for Treating ACTH-Dependent Cushing’s Syndrome in Patients with Cushing’s Disease or Ectopic ACTH/CRH Secretion

What is this study about?

Who Can Join the Study?

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