What is the mechanism of action of this treatment?

The most common treatments for Central Precocious Puberty (CPP) involve the use of gonadotropin-releasing hormone agonists (GnRHa), such as Debio 4326. These treatments work by continuously stimulating the pituitary gland, which paradoxically leads to a downregulation of gonadotropin release, specifically luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This suppression of LH and FSH prevents the premature onset of puberty by halting the production of sex steroids like estrogen and testosterone. For CPP patients, this is crucial as it helps to delay early sexual development, allowing for more normal growth and psychosocial development in line with their chronological age.

What side effects are associated with this type of intervention?

The most common treatments for Central Precocious Puberty (CPP) involve the use of gonadotropin-releasing hormone agonists (GnRHa) to suppress luteinizing hormone (LH). Known side effects of GnRHa treatments include injection site reactions, headaches, mood changes, and potential bone density reduction. These treatments are generally well-tolerated, but long-term use requires monitoring for potential impacts on growth and bone health.

What prior FDA approvals exist?

The FDA has approved several gonadotropin-releasing hormone agonists (GnRHa) for the treatment of Central Precocious Puberty (CPP). These include leuprolide (Lupron Depot-PED), triptorelin (Triptodur), and histrelin (Supprelin LA). These medications work by suppressing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), effectively halting premature puberty. The study of Debio 4326 is in line with these treatments as it also aims to suppress serum LH to prepubertal levels.

What other types of research exist?

Promising alternatives to Debio 4326 for CPP treatment include GnRH agonists such as leuprolide, goserelin, and buserelin, which have shown equivalence in efficacy. Additionally, GnRH antagonists like degarelix, which avoid the initial hormone flare associated with agonists, are also potential alternatives.

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GnRH Antagonist

Debio 4326 for Precocious Puberty (LIBELULA Trial)

Phase 3

Recruiting

Research Sponsored by Debiopharm International SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Onset of development of sex characteristics before the age of 8 years in girls and 9 years in boys

Diagnosis of central precocious puberty and currently receiving GnRHa therapy

Must not have

Presence of an unstable intracranial tumor or an intracranial tumor potentially requiring neurosurgery or cerebral irradiation

Prior or current therapy with medroxyprogesterone acetate, growth hormone, or Insulin-like growth factor-1 (IGF-1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 64 weeks after the last debio 4326 injection in part a or b

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing an injectable medication called Debio 4326. It is aimed at children who start puberty too early and are already receiving another treatment. The goal is to lower a hormone that triggers puberty, helping to delay its onset.

Who is the study for?

This trial is for children diagnosed with central precocious puberty (CPP) who are already on hormone therapy. It's open to kids aged 5-8, and possibly older or younger after an interim review. They should have started puberty early—before age 8 in girls and 9 in boys—and begun treatment within 18 months of these first signs.

What is being tested?

The study tests Debio 4326's ability to maintain low levels of a puberty-related hormone over a year in kids treated for CPP. The goal is to see if this drug can effectively keep the signs of early puberty under control when used alongside standard hormone therapy.

What are the potential side effects?

While specific side effects aren't listed here, drugs like Debio 4326 could potentially cause reactions at the injection site, hormonal imbalances, mood changes, growth rate alterations, or other endocrine system-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I developed early signs of puberty before age 8 (if girl) or 9 (if boy).

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I am being treated for early puberty with hormone therapy.

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I am between 5 and 8 years old.

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My bone age and actual age differ by at least 1 year when I started hormone therapy.

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My hormone test shows a puberty-like response before starting hormone therapy.

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I showed signs of puberty before starting hormone blocker therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a brain tumor that might need surgery or radiation.

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I have been treated with medroxyprogesterone, growth hormone, or IGF-1.

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I have taken medication that can cause seizures.

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I am currently taking blood thinners.

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My child started puberty very early on their own.

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I have a history of seizures, epilepsy, or related brain disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 64 weeks after the last debio 4326 injection in part a or b

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~64 weeks after the last debio 4326 injection in part a or b

This trial's timeline: 3 weeks for screening, Varies for treatment, and 64 weeks after the last debio 4326 injection in part a or b for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Parts A and B: Number of Participants With Change in Hormone Levels

Parts A and B: Plasma Concentration of Triptorelin

Percentage of Participants With Stimulated Serum LH Levels Greater Than (>)5 IU/L at Post Treatment Visit (PTV)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Debio 4326Experimental Treatment1 Intervention

Participants will receive the first injection of Debio 4326, on Day 1 in Part A followed by a second injection 52 weeks later in Part B of the study.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Central Precocious Puberty (CPP) involve the use of gonadotropin-releasing hormone agonists (GnRHa), such as Debio 4326. These treatments work by continuously stimulating the pituitary gland, which paradoxically leads to a downregulation of gonadotropin release, specifically luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This suppression of LH and FSH prevents the premature onset of puberty by halting the production of sex steroids like estrogen and testosterone. For CPP patients, this is crucial as it helps to delay early sexual development, allowing for more normal growth and psychosocial development in line with their chronological age.