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En undersøgelse til evaluering af sikkerhed og tolerabilitet af CVL-231 (Emraclidine) hos voksne deltagere med skizofreni

19. august 2026 opdateret af: AbbVie

Et 52-ugers, fase 2, åbent forsøg til evaluering af den langsigtede sikkerhed og tolerabilitet af CVL-231 (Emraclidine) hos voksne deltagere med skizofreni

Det primære formål med denne undersøgelse er at vurdere den langsigtede sikkerhed og tolerabilitet af oral emraclidin hos voksne deltagere med skizofreni.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

698

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Bulgarien
      • Pazardzhik, Bulgarien, 4400
        • Pazardzhik, Pazardzhik
      • Pleven, Bulgarien, 5800
        • Pleven, Pleven
      • Sliven, Bulgarien, 8800
        • Sliven, Sliven
      • Stara Zagora, Bulgarien, 6003
        • Stara Zagora, Stara Zagora
      • Varna, Bulgarien, 9000
        • Varna, Varna
      • Veliko Tarnovo, Bulgarien, 5000
        • Veliko Tarnovo, Veliko Tarnovo
      • Vratsa, Bulgarien, 3000
        • Vratsa, Vratsa
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgarien, 1431
        • Sofia, Sofia-Grad
      • Sofia, Sofia-Grad, Bulgarien, 1202
        • Sofia, Sofia-Grad
      • Sofia, Sofia-Grad, Bulgarien, 1407
        • Sofia, Sofia-Grad
      • Sofia, Sofia-Grad, Bulgarien, 1510
        • Sofia, Sofia-Grad
      • Sofia, Sofia-Grad, Bulgarien, 1606
        • Sofia, Sofia-Grad
      • Sofia, Sofia-Grad, Bulgarien, 1680
        • Sofia, Sofia-Grad
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85012-2707
        • Phoenix, Arizona
    • Arkansas
      • Bryant, Arkansas, Forenede Stater, 72022-9252
        • Bryant, Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72211-3702
        • Little Rock, Arkansas
    • California
      • Anaheim, California, Forenede Stater, 92805-5854
        • Anaheim, California
      • Bellflower, California, Forenede Stater, 90706-7079
        • Bellflower, California
      • Culver City, California, Forenede Stater, 90230-6632
        • Culver City, California
      • Garden Grove, California, Forenede Stater, 92845-2506
        • Garden Grove, California
      • La Habra, California, Forenede Stater, 90631-3842
        • La Habra, California
      • Lemon Grove, California, Forenede Stater, 91945-2956
        • Lemon Grove, California
      • Montclair, California, Forenede Stater, 91763-2231
        • Montclair, California
      • Orange, California, Forenede Stater, 92868-4447
        • Orange,California
      • Pico Rivera, California, Forenede Stater, 90660-4920
        • Pico Rivera, California
      • Riverside, California, Forenede Stater, 92506-3237
        • Riverside, California
      • San Diego, California, Forenede Stater, 92103-2209
        • San Diego, California
      • San Diego, California, Forenede Stater, 92123
        • San Diego, California
      • San Diego, California, Forenede Stater, 92121
        • San Diego, California
      • Sherman Oaks, California, Forenede Stater, 91403-1747
        • Sherman Oaks, California
      • Torrance, California, Forenede Stater, 90502-4432
        • Torrance, California
      • Walnut Creek, California, Forenede Stater, 94549
        • Walnut Creek, California
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06519-1109
        • New Haven, Connecticut
    • Florida
      • Bonita Springs, Florida, Forenede Stater, 34134-4154
        • Bonita Springs,Florida
      • Fort Myers, Florida, Forenede Stater, 33901-3711
        • Fort Myers, Florida
      • Hialeah, Florida, Forenede Stater, 33012-4648
        • Hialeah, Florida
      • Hialeah, Florida, Forenede Stater, 33016-1814
        • Hialeah, Florida
      • Miami, Florida, Forenede Stater, 33155
        • Miami, Florida
      • Miami, Florida, Forenede Stater, 33122-1335
        • Miami, Florida
      • Miami, Florida, Forenede Stater, 33125-5114
        • Miami, Florida
      • Miami Lakes, Florida, Forenede Stater, 33016-1553
        • Miami Lakes, Florida
      • Miami Lakes, Florida, Forenede Stater, 33016
        • Miami Lakes, Florida
      • Miami Springs, Florida, Forenede Stater, 33166-7225
        • Miami Springs, Florida
      • Oakland Park, Florida, Forenede Stater, 33334-4135
        • Oakland Park, Florida
      • West Palm Beach, Florida, Forenede Stater, 33407-2015
        • West Palm Beach, Florida
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30331
        • Atlanta, Georgia
      • Atlanta, Georgia, Forenede Stater, 30328-4018
        • Atlanta, Georgia
      • Atlanta, Georgia, Forenede Stater, 30318-3102
        • Atlanta, Georgia
      • Decatur, Georgia, Forenede Stater, 30030-3438
        • Decatur, Georgia
      • Savannah, Georgia, Forenede Stater, 31405-5702
        • Savannah,Georgia
    • Illinois
      • Berwyn, Illinois, Forenede Stater, 60402-2248
        • Berwyn, Illinois
      • Chicago, Illinois, Forenede Stater, 60640-5017
        • Chicago, Illinois
      • Chicago, Illinois, Forenede Stater, 60611-3478
        • Chicago, Illinois
      • Chicago, Illinois, Forenede Stater, 60622-1702
        • Chicago, Illinois
      • Chicago, Illinois, Forenede Stater, 60623
        • Chicago, Illinois
      • Chicago, Illinois, Forenede Stater, 60641-4023
        • Chicago, Illinois
    • Louisiana
      • Marrero, Louisiana, Forenede Stater, 70072-3083
        • Marrero, Louisiana
      • Shreveport, Louisiana, Forenede Stater, 71101-4603
        • Shreveport, Louisiana
    • Maryland
      • Gaithersburg, Maryland, Forenede Stater, 20877-1409
        • Gaithersburg, Maryland
    • Mississippi
      • Flowood, Mississippi, Forenede Stater, 39232-8016
        • Flowood, Mississippi
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102-1972
        • Las Vegas, Nevada
    • New Jersey
      • Berlin, New Jersey, Forenede Stater, 08009
        • Berlin, New Jersey
    • New York
      • Cedarhurst, New York, Forenede Stater, 11516-1905
        • Cedarhurst, New York
      • New York, New York, Forenede Stater, 10036-4811
        • New York, New York
      • Staten Island, New York, Forenede Stater, 10314-1607
        • Staten Island, New York
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28211-4849
        • Charlotte, North Carolina
    • Ohio
      • North Canton, Ohio, Forenede Stater, 44718-2567
        • North Canton, Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73102-1018
        • Oklahoma City, Oklahoma
    • Tennessee
      • Franklin, Tennessee, Forenede Stater, 37067-5967
        • Franklin,Tennessee
    • Texas
      • Austin, Texas, Forenede Stater, 78754-5122
        • Austin, Texas
      • DeSoto, Texas, Forenede Stater, 75115-2066
        • DeSoto, Texas
      • Houston, Texas, Forenede Stater, 77043
        • Houston, Texas
      • Houston, Texas, Forenede Stater, 77074
        • Houston, Texas
      • Plano, Texas, Forenede Stater, 75093-0010
        • Plano, Texas
      • Richardson, Texas, Forenede Stater, 75080-3764
        • Richardson, Texas
  • Puerto Rico
      • San Juan, Puerto Rico, 918
        • San Juan, Puerto Rico
      • San Juan, Puerto Rico, 926
        • San Juan, Puerto Rico
  • Ukraine
      • Kropyvnytskyi, Ukraine, 25491
        • Kropyvnytskyi, Kropyvnytskyi
      • Kyiv, Ukraine, 04080
        • Kyiv, Kyïv
      • Smila, Ukraine, 20708
        • Smila, Smila
      • Vinnytsia, Ukraine, 21018
        • Vinnytsia, Vinnytsia
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76011
        • Ivano Frankivsk, Ivano Frankivsk
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79021
        • Lviv, L'vivs'ka Oblast
  • Ungarn
    • Bács-Kiskun county
      • Kalocsa, Bács-Kiskun county, Ungarn, 6300
        • Kalocsa, Bács-Kiskun
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Ungarn, 9024
        • Gyor, Gyor-Moson-Sopron

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Fuldførte 6 ugers postrandomiseringsbehandling i forsøg CVL-231-2001 (NCT05227690) eller CVL-231-2002 (NCT05227703), og som efter investigators mening potentielt kunne have gavn af behandling med emraclidin mod skizofreni.
  2. Primær diagnose af skizofreni i henhold til Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), som bekræftet af Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders.
  3. Deltagere, der har været stabile på antipsykotisk medicin i mindst en 3-måneder i året før screening.
  4. Ambulant status på tidspunktet for underskrivelsen af ​​formularen med informeret samtykke informeret samtykke (ICF).
  5. Villig til at afbryde al forbudt medicin for at imødekomme protokolkrævede udvaskninger før og under prøveperioden.
  6. Evne, efter investigators mening, til at forstå forsøgets karakter, deltage i forsøgsbesøg og overholde protokolkrav.

Ekskluderingskriterier:

  1. Nuværende DSM-5-diagnose, bortset fra skizofreni (bemærk: angstsymptomer sekundære til skizofreni er tilladt.

    • Akutte depressive symptomer inden for 30 dage før underskrivelse af ICF, som kræver behandling med et antidepressivum, er ekskluderende.
    • Akutte maniske symptomer inden for 30 dage før underskrivelse af ICF, som kræver behandling med en humørstabilisator, er ekskluderende.

  2. Enhver af følgende:

    • Skizofreni anses for at være resistent/refraktær over for antipsykotisk behandling i anamnesen (manglende respons på 2 eller flere forløb med tilstrækkelig farmakologisk behandling defineret som en passende dosis pr. etiket og en behandlingsvarighed på mindst 4 uger).
    • Anamnese med kun respons på clozapin-behandling eller manglende respons på clozapin-behandling.
  3. Nuværende eller tidligere historie med signifikant kardiovaskulær, pulmonal, gastrointestinal, nyre-, lever-, metabolisk, genitourinær, endokrin (herunder diabetes mellitus), malignitet (undtagen for basalcellekarcinom i huden og cervikal carcinom in situ, efter investigatorens skøn) , hæmatologisk, immunologisk, neurologisk eller psykiatrisk sygdom, der efter investigatorens eller den medicinske monitors mening kan kompromittere enten deltagernes sikkerhed eller resultaterne af forsøget.
  4. Aktiv infektion i centralnervesystemet, demyeliniserende sygdom, degenerativ neurologisk sygdom, hjernetumor, tidligere hospitalsindlæggelse for alvorligt hovedtraume, krampeanfald (undtagen feberkramper i barndommen) eller enhver sygdom i centralnervesystemet, der anses for at være fremadskridende under forsøget, som kan forvirre fortolkningen af forsøgsresultaterne
  5. Diagnose af moderat til svær stof- eller alkoholmisbrug (undtagen nikotin eller koffein) i henhold til DSM-5-kriterierne inden for 12 måneder før underskrivelsen af ​​ICF.
  6. Risiko for selvmordsadfærd vurderet af C-SSRS og investigators kliniske vurdering.
  7. Enhver tilstand, der muligvis kan påvirke lægemiddelabsorptionen, inklusive, men ikke begrænset til tarmresektioner, bariatrisk vægttabskirurgi, gastrisk banding og gastrectomy
  8. Brug af forbudte lægemidler før randomisering inden for den påkrævede udvaskningsperiode eller vil sandsynligvis kræve forbudt samtidig behandling under forsøget.
  9. Klinisk signifikante abnorme fund på den fysiske undersøgelse, sygehistorie, EKG eller kliniske laboratorieresultater ved screening.
  10. Positivt resultat af graviditetstest før modtagelse af forsøgslægemiddel (IMP).

Bemærk: kvindelige deltagere, der er gravide, ammer eller planlægger at blive gravide under IMP-behandling eller inden for 7 dage efter den sidste dosis af IMP, er også udelukket.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CVL-231-2001/2002 Active Rollover
Participants who completed treatment with emraclidine in one of the double-blind, placebo-controlled Phase 2 efficacy trials (CVL-231-2001; NCT05227690 or CVL-231-2002; NCT05227703) were denoted as "active rollover" participants. They received emraclidine 30 mg tablets orally once daily (QD) for 52 weeks in this study.
Medicin: Emraclidine 30 mg
Emraclidine 30 mg, oral (tablet), once per day for 52 weeks
Andre navne:
  • CVL-231
  • ABBV-1231
Eksperimentel: CVL-231-2001/2002 Placebo Rollover
Participants who completed treatment with placebo for emraclidine in one of the double-blind, placebo-controlled Phase 2 efficacy trials (CVL-231-2001; NCT05227690 or CVL-231-2002; NCT05227703) were denoted as "placebo rollover" participants. They received emraclidine 30 mg tablets orally once daily (QD) for 52 weeks in this study.
Medicin: Emraclidine 30 mg
Emraclidine 30 mg, oral (tablet), once per day for 52 weeks
Andre navne:
  • CVL-231
  • ABBV-1231
Eksperimentel: De Novo
Participants with stable schizophrenia who were not enrolled in one of the prior Phase 2 efficacy trials were denoted as "de novo" participants. They received emraclidine 30 mg tablets orally once daily (QD) for 52 weeks in this study.
Medicin: Emraclidine 30 mg
Emraclidine 30 mg, oral (tablet), once per day for 52 weeks
Andre navne:
  • CVL-231
  • ABBV-1231

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Tidsramme: From first dose of study drug until 28 days following last dose of study drug (up to Week 56)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
From first dose of study drug until 28 days following last dose of study drug (up to Week 56)
Number of Participants With Out-of-Range Vital Signs Occurring Post-Baseline
Tidsramme: Baseline; from first dose of study drug up to Week 52
Vital signs were obtained after the participant had been supine and at rest for 3 minutes and included systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate.
Baseline; from first dose of study drug up to Week 52
Number of Participants With Clinically Significant Changes in Body Weight
Tidsramme: Baseline; from first dose of study drug up to Week 52
Participants' body weights were measured and recorded.
Baseline; from first dose of study drug up to Week 52
Number of Participants With Post-Baseline Clinically Significant Physical Examinations and Neurological Examinations
Tidsramme: Baseline; from first dose of study drug up to Week 52
The number of participants with clinically significant changes in physical and neurological examination results post-treatment was documented.
Baseline; from first dose of study drug up to Week 52
Number of Participants With Clinically Significant Post-Baseline Changes in Electrocardiogram (ECG) Values
Tidsramme: Baseline; from first dose of study drug up to Week 52
12-lead electrocardiogram (ECG) recordings were obtained after the participant had been supine and at rest for at least 3 minutes.
Baseline; from first dose of study drug up to Week 52
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Tidsramme: Baseline; from first dose of study drug up to Week 52
Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes.
Baseline; from first dose of study drug up to Week 52
Number of Participants With Clinically Significant Changes in Metabolic Parameter Values
Tidsramme: Baseline; from first dose of study drug up to Week 52
Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes in metabolic parameter values.
Baseline; from first dose of study drug up to Week 52
Number of Participants With Suicide-Related Treatment-Emergent Events Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Baseline; from first dose of study drug up to Week 52
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Baseline; from first dose of study drug up to Week 52
Change From Baseline in Simpson Angus Scale (SAS) Total Score
Tidsramme: Baseline; Weeks 4, 8, 12, 20, 26, 32, 38, 44, and 52
The SAS consists of a list of 10 symptoms of parkinsonism. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items. Baseline was defined as the last value obtained prior to initiation of study drug. Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate an improvement in symptoms.
Baseline; Weeks 4, 8, 12, 20, 26, 32, 38, 44, and 52
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Rating Score
Tidsramme: Baseline; Weeks 4, 8, 12, 20, 26, 32, 38, 44, and 52

The Abnormal Involuntary Movement Scale assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1-4), extremity movements (items 5 and 6), and trunk movements (item 7) are observed unobtrusively while the participant is at rest, and the investigator also makes global judgments on the participant's dyskinesias (items 8-10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the participant's dental status.

The AIMS Movement Rating Score is defined as the sum of individual scores from items 1-7, ranging from 0 to 28. A lower score indicates less severe or absent abnormal movements. A negative change in the mean from Baseline indicates improvement in the severity of abnormal involuntary movements.
Baseline; Weeks 4, 8, 12, 20, 26, 32, 38, 44, and 52
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Evaluation Score
Tidsramme: Baseline; Weeks 4, 8, 12, 20, 26, 32, 38, 44, and 52
The BARS consists of 4 items related to akathisia. The fourth item, reported here, is the Global Clinical Evaluation Score. The Global Clinical Evaluation Score is evaluated using a 6-point scale, ranging from 0 to 5, with 0 representing absence of symptoms and a score of 5 representing severe akathisia. A negative change from baseline indicates an improvement in symptoms.
Baseline; Weeks 4, 8, 12, 20, 26, 32, 38, 44, and 52

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AbbVie

Efterforskere

  • Studieleder: ABBVIE INC., AbbVie

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2022

Primær færdiggørelse (Faktiske)

25. juni 2025

Studieafslutning (Faktiske)

25. juni 2025

Datoer for studieregistrering

Først indsendt

29. juni 2022

Først indsendt, der opfyldte QC-kriterier

29. juni 2022

Først opslået (Faktiske)

5. juli 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CVL-231-2003
  • 2022-001151-16 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner