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52 veckors studie av säkerhet, PK och effektivitet av XYOSTED® för testosteronersättning hos manliga ungdomar med hypogonadism

5 november 2026 uppdaterad av: Halozyme Therapeutics

Open-label, multipeldos, 52-veckorsstudie för att utvärdera säkerheten, farmakokinet och effekten av XYOSTED® för testosteronersättning hos manliga ungdomar med brist eller frånvaro av endogent testosteron på grund av primär eller sekundär hypogonadism

This is a 52-week open label single arm study + 24-Month long-term safety extension to investigate the effects of XYOSTED, as testosterone replacement therapy, on adolescent males with either primary or secondary hypogonadism.

The study aims to determine the effectiveness of XYOSTED measured by continuation or induction of puberty in addition to XYOSTED dosage, safety and testosterone levels.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a Phase 3/4, open-label, multicenter study in approximately 100 males 12 to < 18 years of age with primary or secondary hypogonadism (congenital or acquired). Each participant will be screened for eligibility within 28 days before receiving his first dose of study drug on Day 1. During the Screening period, each participant will have a full clinical examination with pubertal staging, including 2 separate serum total testosterone (TT) measurements obtained in the early morning, where the average (Cavg) will be considered baseline value. Each participant will be categorized as having primary or secondary hypogonadism prior to dosing on Day 1.

Participants meeting all eligibility criteria will be assigned to a starting dose of XYOSTED based on their weight and Targeted Tanner Stage on Day 1. The Targeted Tanner Stage will be determined during Screening by an experienced pediatric endocrinologist.

Participants will have dose adjustments during the study to achieve their Targeted Tanner Stage. Dose adjustments will be based on reviewing the TT concentration between doses (Cmid) by measuring serum TT 14 days after the administration of XYOSTED for participants receiving the Q4W schedule, 7 days after the administration of XYOSTED for participants who are on the Q2W schedule, and 4 days after administration of XYOSTED for participants on the Q1W schedule. Participants will be evaluated for further dose adjustments approximately every 3 months to achieve the desired targeted TT level.

Following the 52-week primary study, participants may join a 24-month long-term safety extension study to continue the evaluation of XYOSTED in this population. Participants will return to the clinic at 6-month intervals for evaluation for clinical evaluations, and laboratory and pharmacokinetic assessments.

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna, 90027
        • Rekrytering
        • Children's Hospital Los Angeles
      • Los Angeles, California, Förenta staterna, 90048
        • Rekrytering
        • Cedars-Sinai Medical Center
      • San Diego, California, Förenta staterna, 92123
        • Rekrytering
        • Rady Children's Hospital - San Diego
      • San Francisco, California, Förenta staterna, 94143
        • Rekrytering
        • University of California San Francisco
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
        • Rekrytering
        • Children's Hospital Colorado
    • Florida
      • Jacksonville, Florida, Förenta staterna, 32207
        • Rekrytering
        • Nemours Children's Specialty Care - Jacksonville
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Rekrytering
        • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02115
        • Rekrytering
        • Boston Children's Hospital
      • Worcester, Massachusetts, Förenta staterna, 01655
        • Rekrytering
        • University of Massachusetts Memorial Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Förenta staterna, 55454
        • Rekrytering
        • M Health Fairview U Minnesota
    • Missouri
      • St Louis, Missouri, Förenta staterna, 63110
        • Rekrytering
        • Washington University School of Medicine in St. Louis
    • Nevada
      • Las Vegas, Nevada, Förenta staterna, 89113
        • Rekrytering
        • The DOCS
    • New York
      • The Bronx, New York, Förenta staterna, 10467
        • Rekrytering
        • Children's Hospital at Montefiore
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73104
        • Rekrytering
        • OUHSC Pediatric Diabetes & Endocrinology
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Rekrytering
        • Children's Hospital of Philadelphia
    • South Carolina
      • Columbia, South Carolina, Förenta staterna, 29203
        • Rekrytering
        • Prisma Health Children's Hospital - Midlands
    • Texas
      • El Paso, Texas, Förenta staterna, 79902
        • Rekrytering
        • MedResearch
      • Houston, Texas, Förenta staterna, 77030
        • Rekrytering
        • Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84112
        • Rekrytering
        • Primary Children's Hospital
    • Virginia
      • Charlottesville, Virginia, Förenta staterna, 22908
        • Rekrytering
        • University of Virginia School of Medicine
    • Washington
      • Seattle, Washington, Förenta staterna, 98105
        • Rekrytering
        • Seattle Children's Hospital
      • Tacoma, Washington, Förenta staterna, 98405
        • Rekrytering
        • MultiCare Institute for Research & Innovation

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år till 17 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

Inclusion Criteria:

  1. Diagnosed with a deficiency or absence of endogenous testosterone due to primary or secondary hypogonadism of a known etiology. Children with combined hormone deficiencies are permitted to enroll (but the child must already be receiving treatment for concomitant hormonal deficiencies)

  2. Participants receiving prior testosterone treatment must be receiving a stable dose for at least 12 weeks prior to Screening. Treatment naive participants are permitted to enroll.

  3. Have parent(s) or a legal guardian who will voluntarily provide written informed consent for the child to participate in the study

  4. Willing to provide assent for participation in the study

  5. Be a male 12 to < 18 years of age at the time of consent/assent

  6. Have Legally Authorized Representative who is able to understand and comply with all study procedures and agrees to have the child participate in the study program as outlined in the protocol

  7. Requires chronic pharmacologic support for the initiation and/or continuation of pubertal maturation

  8. Have a body mass index (BMI)-for-age greater than the 5th percentile and weigh ≥ 30 kg.

  9. If sexually active with a female partner of child-bearing potential, agrees to:

    1. Practice true abstinence including 30 days after the last IP administration, or,
    2. Use 2 adequate forms of highly effective contraception, one of which should be a physical barrier, during the study and for 30 days after the last IP administration.

Exclusion Criteria:

  1. Has abnormal thyroid function tests at Screening. May supplement per usual clinical practice and rescreen up to two times.
  2. Has suspected or known constitutional growth delay in growth and puberty (CDGP)
  3. Has evidence of possible nutritional or gastrointestinal disorder that may impact growth (e.g., abrupt weight loss within the 3 months prior to Screening, unmanaged celiac disease, inflammatory bowel disease)
  4. Has a known allergy or hypersensitivity to XYOSTED, or to any of its ingredients (testosterone enanthate and sesame oil)
  5. Participants receiving prior treatment with testosterone who are not on a stable dose for at least 12 weeks prior to Screening.
  6. Has an allergy to foods or products containing sesame seeds or sesame oil
  7. Has Stage 1 hypertension, defined as the average of 2 or more seated right arm BP measurements exceeding the 95th percentile for age, sex, and height, or SBP ≥ 130 mm Hg and/or DBP ≥ 80 mm Hg at Screening or Day 1.
  8. Has a clinically significant abnormal clinical laboratory test value at Screening, as determined by the Investigator including hematocrit > 48%, or >50% for patients living at high altitude if not receiving testosterone treatment, or hematocrit > 52% if already receiving testosterone treatment.
  9. Has a history of deep venous thrombosis or pulmonary embolism
  10. Has evidence of a clinically significant 12-lead electrocardiogram (ECG) abnormality at Screening, as determined by the Investigator
  11. Has a current suspected or diagnosed (and unresected) tumor of the pituitary gland with the exception of Rathke's cleft cyst or a stable non-functioning pituitary microadenoma (ie, lesion size < 10 mm that has not increased in size over a period of 1 year on repeat imaging), as determined by the Investigator
  12. Has an active malignancy or has received treatment for a malignancy within the 12 months before Screening
  13. Is currently receiving antipsychotic medication for any reason or is currently receiving selective serotonin reuptake inhibitor (SSRI) medication for depression
  14. Is receiving any other medication or has a condition that would preclude safe participation in the study or confound the evaluation of safety, as determined by the Investigator
  15. Has a history of suicidal behavior (i.e., actions intended to harm oneself), suicidal ideation (i.e., thoughts and plans about suicide), or suicide attempts
  16. Has any affirmative responses on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire to questions #3, #4, or #5 or any affirmative response to questions #1 or #2 within the past 12 months on the suicide ideation questions (first section) OR any affirmative response on the suicidal behavior questions (the second section).
  17. Is currently taking supraphysiologic doses of systemic glucocorticoids for more than 3 weeks, except for intermittent short courses of exogenous glucocorticoids as needed for the treatment of asthma
  18. Has received any other investigational compound within 1 month prior to screening or 5 half-lives of the investigational product (whichever is longer)
  19. Has received gonadotropin-releasing hormone (GnRH) agonists, aromatase inhibitors, androgens (eg, dehydroepiandrosterone [DHEA]), anabolic steroids such as oxandrolone, or other sex steroids within 12 months before the Screening visit, or would require these treatments at any time during the study.
  20. Receiving cytochrome P450 (CYP) 3A4 or P glycoprotein (P-gp) inhibitors/inducers or medications that are metabolized by CYP3A4 or P-gp within 30 days of enrolment.
  21. Has a history of alcohol or drug abuse
  22. Has a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other conditions that would preclude participation in the study, as determined by the Investigator
  23. Has chronic urticaria or dermatographism
  24. Has 25-hydroxy-vitamin D blood level < 20 ng/mL. Participants with initial vitamin D blood measurement < 20 ng/mL may enroll while they receive supplementation per clinical practice

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Participants

XYOSTED Injection (Testosterone enanthate) 25 mg / 0.5 mL, 50 mg / 0.5 mL, 75 mg / 0.5 mL, 100 mg / 0.5 mL
Kombinationsprodukt: Testosterone enanthate

XYOSTED 25 mg / 0.5 mL; XYOSTED 50 mg / 0.5 mL; XYOSTED 75 mg / 0.5 mL; XYOSTED 100 mg / 0.5 mL

Andra namn:
  • XYOSTED Injektion

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Ökning av testosteron, som utvärderats med hjälp av PK-parametrar
Tidsram: Från inskrivning till studieslutsbedömningar vecka 53
Från inskrivning till studieslutsbedömningar vecka 53

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of participants demonstrating either progression through Tanner Stages of puberty or attainment of Tanner Stage 5 by the end of the study
Tidsram: End of Study Assessment at Week 53

Evaluated through clinical//physical examination
End of Study Assessment at Week 53
• Percentage of patients that had an increase in stretched penile length
Tidsram: End of Study Assessment at Week 53

Evaluated through clinical//physical examination
End of Study Assessment at Week 53
Change from Screening or Baseline in DEXA bone density for total body less head (TBLH) and PA spine
Tidsram: End of Study Assessment at Week 53

Evaluated through DEXA scan using age-appropriate software
End of Study Assessment at Week 53
Change from Screening or Baseline in body composition by DEXA scan
Tidsram: End of Study Assessment at Week 53

Evaluated through DEXA scan using age-appropriate software
End of Study Assessment at Week 53
Change from Screening or Baseline in bone age as determined by X-ray
Tidsram: End of Study Assessment at Week 53

Evaluated through X-ray using central readers
End of Study Assessment at Week 53
Change from Screening or Baseline in BMI-for-age percentile
Tidsram: End of Study Assessment at Week 53

Evaluated through clinical//physical examination
End of Study Assessment at Week 53
• Change from Screening or Baseline in Height Velocity (HV)
Tidsram: End of Study Assessment at Week 53

Evaluated through clinical//physical examination
End of Study Assessment at Week 53

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
PK endpoints
Tidsram: End of Study Assessment at Week 53

Total Testosterone concentration
End of Study Assessment at Week 53
Evaluation of Safety Endpoints including Treatment-Emergent Adverse Events
Tidsram: End of Study Assessment at Week 53

Frequency and Severity of TEAEs
End of Study Assessment at Week 53

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Halozyme Therapeutics

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 mars 2025

Primärt slutförande (Beräknad)

1 mars 2028

Avslutad studie (Beräknad)

1 mars 2030

Studieregistreringsdatum

Först inskickad

6 november 2024

Först inskickad som uppfyllde QC-kriterierna

13 november 2024

Första postat (Faktisk)

14 november 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ATRS QST-19-007

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

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