A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
NCT ID: NCT06129539
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
56 participants
INTERVENTIONAL
2024-07-31
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Debio 4326
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.
Debio 4326
Administered as an intramuscular (IM) injection
Interventions
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Debio 4326
Administered as an intramuscular (IM) injection
Eligibility Criteria
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Inclusion Criteria
2. Onset of development of sex characteristics (i.e., breast development in girls or testicular enlargement in boys according to the Tanner method) before the age of 8 years in girls and 9 years in boys.
3. Initially, only participants aged (a) 5 to 8 years inclusive (i.e., \<9 years) are eligible. The Sponsor will determine based on the recommendation of the DMC following the interim analysis whether participants aged (b) 2 to 4 years inclusive (i.e., \<5 years) and/or (c) 9 to 10 years inclusive (i.e., \<11 years) may be recruited.
4. Participant to receive at least 1 year of gonadotropin-releasing hormone agonist (GnRHa) therapy from study treatment start.
5. (a) Pre-treated participants: Start of initial GnRHa therapy no later than 18 months after onset of the first signs of CPP.
(b) Treatment-naive participants: Start of Debio 4326 treatment no later than 18 months after onset of the first signs of CPP.
6. (a) Pre-treated participants: Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year based on historical values at the initiation of the GnRHa therapy.
(b) Treatment-naive participants: Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year.
7. (a) Pre-treated participants: Pubertal-type LH response (LH ≥6 IU/L) following a GnRH/GnRHa stimulation test, or random non-stimulated serum LH \>0.5 IU/L (if considered local standard of care), based on historical values prior to the initiation of GnRHa therapy.
(b) Treatment-naive participants: Pubertal-type LH response (≥6 IU/L) 30 minutes following a GnRHa \[leuprolide acetate 20 micrograms per kilogram (μg/kg) subcutaneous injection (SC)\] stimulation test before treatment initiation.
8. (a) Pre-treated participants: Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 milliliter (mL) (cubic centimeter \[cc\]) for boys, prior to the initiation of GnRHa therapy.
(b) Treatment-naive participants: Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 mL (cc) for boys.
Exclusion Criteria
2. (a) Pre-treated participants: Non-progressing, isolated premature thelarche prior to the initial GnRHa therapy.
(b) Treatment-naive participants: Non-progressing, isolated premature thelarche.
3. Presence of an unstable intracranial tumor or an intracranial tumor potentially requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible.
4. Any other condition or chronic illness possibly interfering with growth (e.g., renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor).
5. Other than GnRHa therapy in pre-treated participants, any ongoing treatment with a potential effect on serum levels of gonadotropins or sex steroids, or possibly interfering with growth, opioids, central nervous system \[CNS\] stimulants).
6. Prior or current therapy with medroxyprogesterone acetate, growth hormone, or Insulin-like growth factor-1 (IGF-1).
7. Diagnosis of short stature, i.e., more than 2.25 standard deviations (SD) below the mean height-for-age.
8. Known history of seizures, epilepsy, and/or central nervous system disorders that may have been associated with seizures or convulsions.
9. Prior (within 2 months of study treatment start) or current use of medications that have been associated with seizures or convulsions.
10. Use of anticoagulants (heparin or coumarin derivatives).
5 Years
8 Years
ALL
No
Sponsors
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Debiopharm International SA
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Debiopharm International SA
Locations
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TMC HealthCare
Tucson, Arizona, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
University of California San Francisco-Benioff Children's Hospital
San Francisco, California, United States
Wolfson's Children's Hospital
Jacksonville, Florida, United States
Nemours Children's Health
Pensacola, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Ann and Robert H.Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana University/Riley Hospital for Children
Indianapolis, Indiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Children's Hospital at Montefiore
New York, New York, United States
Akron Children's Hospital
Akron, Ohio, United States
Investigational Drug Service, The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Prisma Health Pediatric Endocrinology
Columbia, South Carolina, United States
Research Institute of Dallas
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Virginia Commonwealth University Health System
Richmond, Virginia, United States
Instituto de Investigaciones Metabolicas (IDIM)
Buenos Aires, , Argentina
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
Buenos Aires, , Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, , Argentina
Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L
San Miguel de Tucumán, , Argentina
Hospital Da Criança de Brasília Jose Alencar
Brasília, , Brazil
CETI - Centro de Estudos em Terapias Inovadoras Ltda
Curitiba, , Brazil
Hospital Universitario Walter Cantidio
Fortaleza, , Brazil
Clínica de Endocrinologia e Metabologia Ltda
Lago Sul, , Brazil
Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS
Porto Alegre, , Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, , Brazil
CPCLIN - Centro de Pesquisas Clínicas Ltda.
São Paulo, , Brazil
CPQuali Pesquisa Clinica
São Paulo, , Brazil
Irmandade Santa Casa de São Paulo
São Paulo, , Brazil
Integral Pesquisa e Ensino
Votuporanga, , Brazil
ENDOMET
Antofagasta, , Chile
Hospital Clinico San Borja Arriaran (HCSBA)
Santiago, , Chile
Christus Latam Hub Center of Excellence and Innovation S C
Monterrey, , Mexico
Countries
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Other Identifiers
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Debio 4326-301
Identifier Type: -
Identifier Source: org_study_id