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En studie for å vurdere effektivitet og sikkerhet av oktreotid subkutant depot hos pasienter med akromegali (ACROINNOVA 1)

29. juli 2026 oppdatert av: Camurus AB

En fase 3, randomisert, dobbeltblind, placebokontrollert, multisenterforsøk for å vurdere effektivitet og sikkerhet av oktreotid subkutant depot (CAM2029) hos pasienter med akromegali

Formålet med denne studien er å vurdere effektiviteten og sikkerheten til CAM2029 hos pasienter med akromegali. Pasientene vil bli randomisert til enten CAM2029 eller placebo administrert subkutant én gang i måneden i løpet av 6 måneder.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

72

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90095
        • UCLA Department of Medicine Division of Endocrinology
      • Palo Alto, California, Forente stater, 94305
        • Stanford University Medical Center
    • Florida
      • Miami, Florida, Forente stater, 33130
        • Prufen Clinical Research LLC
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48106
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Washington University in St. Louis, School of Medicine
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89148
        • Palm Research Center
    • New York
      • New York, New York, Forente stater, 10018
        • Columbia University Medical Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45267
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, Forente stater, 15212
        • Allegheny Endocrinology Associates
    • Texas
      • Dallas, Texas, Forente stater, 75231
        • Research Institute of Dallas
  • Hellas
      • Athens, Hellas, 115 27
        • General Hospital of Athens "Laiko", Endocrinology University Clinic
      • Athens, Hellas, 115 28
        • Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism
      • Thessaloniki, Hellas, 546 42
        • General Hospital of Thessaloniki "Ippokratio"
  • Italia
      • Genova, Italia, 16132
        • IRCCS Policlinico San Martino
      • Naples, Italia, 80131
        • Azienda Universitaria "Federico II"
      • Padova, Italia, 35128
        • Azienda Ospedaliera Padova, Department of Internal medicine
      • Roma, Italia
        • Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology
      • Verona, Italia, 37134
        • AOUI Verona, Policlinic of GB Rossi
  • Polen
      • Krakow, Polen, 30-688
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
      • Krakow, Polen, 31-011
        • Centrum Nowoczesnych Terapii "Dobry Lekarz"
      • Lodz, Polen, 90-644
        • AmiCare Sp. z o.o. Sp. k.
      • Piekary Śląskie, Polen, 41-940
        • Piekarskie Centrum Medyczne, Szpital Miejski
  • Russland
      • Kazan', Russland, 420087
        • Interregional Clinical Diagnostic Center
      • Moscow, Russland
        • "Atlas" Medical Center
      • Moscow, Russland
        • Sechenov Moscow First State Medical University
      • Moscow, Russland
        • Vladimirsky Moscow Regional Research Clinical Institute
      • Novosibirsk, Russland, 630087
        • Novosibirsk State Regional Clinical Hospital
      • Ryazan, Russland, 420087
        • Interregional Clinical Diagnostic Center
      • Saratov, Russland, 410053
        • Saratov Regional Clinic Hospital
  • Spania
      • A Coruña, Spania, 15006 A
        • University Hospital Complex A Coruña
      • Alicante, Spania, 03010
        • University Hospital of Alicante
      • Barcelona, Spania, 08035
        • Hospital Universitario Vall d'Hebron
      • Madrid, Spania, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spania, 28009
        • Hospital Universitario Gregorio Marañón
      • Santiago de Compostela, Spania, 15706
        • Complejo Hospitalario Universitario Santiago de Compostela
      • Seville, Spania, 41013
        • University Hospital Virgen del Rocio
      • Valencia, Spania, 46026
        • Hospital Universitario y Politécnico La Fe
      • Valencia, Spania, 46600
        • Hospital Universitario de La Ribera
  • Storbritannia
      • Birmingham, Storbritannia, B15 2TT
        • College of Medical and Dental Sciences
      • Coventry, Storbritannia, CV2 2DX
        • University Hospitals Coventry and Warwickshire NHS Trust
      • Leeds, Storbritannia, LS97TF
        • Leeds Teaching Hospitals NHS Trust
      • Manchester, Storbritannia, M20 4BX
        • The Christie NHS Foundation Trust
      • Salford, Storbritannia, M6 8HD
        • Salford Royal Foundation Trust
  • Tyrkia (Türkiye)
      • Antalya, Tyrkia (Türkiye), 07985
        • Akdeniz University Faculty of Medicine Department of Endocrinology
      • Aydin, Tyrkia (Türkiye), 09010
        • Aydın Adnan Menderes University Research and Application Hospital
      • Denizli, Tyrkia (Türkiye), 20070
        • Pamukkale University Faculty of Medicine Department of Endocrinology
      • Eskişehir, Tyrkia (Türkiye), 26480
        • Eskisehir Osmangazi University Medical Faculty
      • Fatih, Tyrkia (Türkiye), 34098
        • Istanbul University Medical Faculty
      • Kocaeli, Tyrkia (Türkiye), 41000
        • Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism
      • Malatya, Tyrkia (Türkiye), 44000
        • Inonu University Medical Faculty Endocrinology Department
      • Melikgazi, Tyrkia (Türkiye), 38039
        • Erciyes University Medical Faculty, Dept. of Endocrinology
      • Trabzon, Tyrkia (Türkiye), 61080
        • Karadeniz Technical University Farabi Hospital
      • Zonguldak, Tyrkia (Türkiye), 67600
        • Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus
  • Tyskland
      • Essen, Tyskland, 45147
        • Universitätsklinikum Essen
      • Frankfurt, Tyskland, 60590
        • Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin
      • Freiburg im Breisgau, Tyskland, 79601
        • Universitatsklinikum Freiburg
      • Munich, Tyskland, 80336
        • LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV
      • Munich, Tyskland, 81667
        • Medicover Neuroendokrinologie
      • Oldenburg, Tyskland, 26122
        • Medicover Oldenburg MVZ
  • Ungarn
      • Budapest, Ungarn, 1062
        • Military Healt Center, 2nd Department of Internal Medicine
      • Szeged, Ungarn, 6720
        • SZTE ÁOK I.sz. Belgyógyászati Klinika

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Mannlige eller kvinnelige pasienter, ≥18 år ved screening
  • Kunne gi skriftlig informert samtykke til å delta i rettssaken før prøverelaterte prosedyrer utføres
  • Diagnose av akromegali ved historisk bevis på (vedvarende eller tilbakevendende) akromegali
  • Behandling med en stabil dose av oktreotid LAR eller lanreotid ATG i minst 3 måneder som monoterapi før screening
  • IGF-1-nivåer ≤1xULN ved screening
  • Tilstrekkelig funksjon av lever, bukspyttkjertel, nyre og benmarg
  • Normalt EKG

Ekskluderingskriterier:

  • GH ≥2,5 μg/L ved screening (syklus)
  • Har mottatt medisinsk behandling for akromegali med pasireotid (innen 6 måneder før screening), pegvisomant (innen 3 måneder før screening), dopaminagonister (innen 3 måneder før screening) eller andre undersøkelsesmidler (innen 30 dager eller 5 halveringstider før screening [det som er lengst]
  • Pasienter som vanligvis tar oktreotid LAR eller lanreotid ATG sjeldnere enn hver 4. uke (f. hver 6. uke eller 8. uke)
  • Pasienter med kompresjon av den optiske chiasmen som forårsaker synsfeltdefekter for hvem kirurgisk inngrep er indisert
  • Pasienter som har gjennomgått større operasjoner/kirurgisk behandling uansett årsak innen 1 måned fra screening
  • Pasienter som har gjennomgått hypofysekirurgi innen 6 måneder før screening
  • Pasienter som tidligere har fått bestråling av hypofysen
  • Pasienter med dårlig kontrollert diabetes mellitus (hemoglobin A1c >8,0 %)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CAM2029 (oktreotid subkutant depot)
CAM2029 (oktreotid subkutant depot) 20mg/1,0 ml for 20 mg dose, subkutan injeksjon én gang i måneden, seks måneders behandling. Hvis nedtitrering er nødvendig, er 10 mg/0,5 ml for 10 mg dose tilgjengelig.
Legemiddel: CAM2029 (oktreotid subkutant depot)
Oktreotid subkutant depot for månedlige injeksjoner hos akromegalipasienter
Andre navn:
  • CAM2029
Placebo komparator: Matchende placebo
Placebo (subkutant depot) 1,0 ml, subkutan injeksjon én gang i måneden, seks måneders behandling. Hvis nedtitrering er nødvendig, er 0,5 ml dose tilgjengelig.
Legemiddel: Matchende placebo
Matchende placebo for CAM2029
Andre navn:
  • placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants With Mean Insulin-like Growth Factor -1 (IGF-1) Levels ≤1 x Upper Limit of Normal (ULN) at Week 22/24
Tidsramme: Week 22 and 24
If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the intention-to-treat (ITT) analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Week 22 and 24

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants With Mean IGF-1 Levels ≤1x Upper Limit or Normal (ULN) at Week 22/24, Including Participants With Dose Reduction
Tidsramme: Week 22 and 24
First key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP and/or was switched to rescue medication. For this endpoint, a patient who had their dose reduced was not directly classified as a non-responder. No participant had their dose reduced during the trial. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants"
Week 22 and 24
Proportion of Participants With Mean IGF-1 Levels ≤1xULN at Week 22/Week 24 and Mean Growth Hormone (GH) Levels <2.5 µg/L at Week 24
Tidsramme: Week 22 and 24
Second key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample or no GH value at Week 24. A composite strategy was assumed for intercurrent events, and a patient was considered as a non-responder if they discontinued IMP or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was based on the patient's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Week 22 and 24
Proportion of Participants With Mean GH Levels <2.5 µg/L at Week 24
Tidsramme: Week 24
For the responder analysis of mean GH <2.5 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Week 24
Proportion of Participants With Mean GH Levels <1.0 µg/L at Week 24
Tidsramme: Week 24
For the responder analysis of mean GH <1.0 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Week 24
Number of Participants With Treatment Emergent Adverse Events
Tidsramme: Week 0 to 24
A treatment emergent adverse event was defined as an adverse event that occurred during or after the first administration of the IMP to the end of trial visit or the next dose of any acromegaly treatment, whichever came first.
Week 0 to 24
Proportion of Participants/Partners Declared Competent by a Healthcare Professional to Administer Intervention
Tidsramme: Week 0 to 20 and Week 24
During participants'/partners' first three attempts during the trial period of 24 weeks whenever these visits took place. Percentages were based on those who opted for self-/partner-administration.
Week 0 to 20 and Week 24
Octreotide Plasma Concentrations Over Time
Tidsramme: Week 0 to 24
Plasma samples were taken pre-dose on dosing days.
Week 0 to 24

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Camurus AB

Etterforskere

  • Hovedetterforsker: Pamela Freda, M.D, Columbia University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. august 2019

Primær fullføring (Faktiske)

2. mai 2023

Studiet fullført (Faktiske)

2. mai 2023

Datoer for studieregistrering

Først innsendt

29. august 2019

Først innsendt som oppfylte QC-kriteriene

30. august 2019

Først lagt ut (Faktiske)

3. september 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HS-18-633
  • 2019-001191-11 (EudraCT-nummer)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere