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Evaluering af Sonelokimab til behandling af patienter med aktiv psoriasisgigt

17. august 2026 opdateret af: MoonLake Immunotherapeutics AG

Fase 2, randomiseret, parallelgruppe, dobbeltblind, placebokontrolleret undersøgelse af Sonelokimab hos patienter med aktiv psoriasisgigt

Dette er et studie, der skal demonstrere den kliniske effekt og sikkerhed af nanobody® sonelokimab administreret subkutant (sc) sammenlignet med placebo i behandlingen af ​​voksne deltagere med aktiv psoriasisgigt. Studiet omfatter behandling med adalimumab som en aktiv referencearm.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patienter vil blive randomiseret til at modtage en af ​​tre sonelokimab-behandlingsregimer, adalimumab eller placebo. Primær effektevaluering vil finde sted i uge 12. Patienterne vil blive tildelt yderligere 12 ugers behandling med sonelokimab eller adalimumab baseret på responsvurdering i uge 12. I visse lande afsluttes behandlingen i uge 12.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

207

Fase

  • Fase 2

Kontakter og lokationer

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

Studiekontakt

Studiesteder

      • Pleven, Bulgarien, 5800
        • Clinical Site
      • Pleven, Bulgarien, 5803
        • Clinical Site
      • Plovdiv, Bulgarien, 4002
        • Clinical Site
      • Plovdiv, Bulgarien, 4003
        • Clinical Site
      • Rousse, Bulgarien, 7002
        • Clinical Site
      • Sofia, Bulgarien, 1336
        • Clinical Site
      • Stara Zagora, Bulgarien, 6000
        • Clinical Site
      • Varna, Bulgarien, 9000
        • Clinical Site
      • Tallinn, Estland, 10128
        • Clinical Site
      • Tartu, Estland, 20708
        • Clinical Site
    • California
      • Rancho Mirage, California, Forenede Stater, 92260
        • Clinical Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Forenede Stater, 16635
        • Clinical Site
      • Bialystok, Polen, 15-879
        • Clinical Site
      • Bialystok, Polen, 15-077
        • Clinical Site
      • Bialystok, Polen, 15-351
        • Clinical Site
      • Bydgoszcz, Polen, 85-065
        • Clinical Site
      • Bydgoszcz, Polen, 85-168
        • Clinical Site
      • Elblag, Polen, 82-300
        • Clinical Site
      • Gdynia, Polen, 81-338
        • Clinical Site
      • Krakow, Polen, 30-727
        • Clinical Site
      • Lodz, Polen, 90-242
        • Clinical Site
      • Nadarzyn, Polen, 05-830
        • Clinical Site
      • Nowa Sól, Polen, 67-100
        • Clinical Site
      • Olsztyn, Polen, 10-117
        • Clinical Site
      • Poznan, Polen, 61-113
        • Clinical Site
      • Sochaczew, Polen, 96-500
        • Clinical Site
      • Swidnica, Polen, 58-100
        • Clinical Site
      • Warsaw, Polen, 02-665
        • Clinical Site
      • Wroclaw, Polen, 52-416
        • Clinical Site
      • Madrid, Spanien, 28100
        • Clinical Site
      • Sabadell, Spanien, 8208
        • Clinical Site
      • Santiago de Compostela, Spanien, 15702
        • Clinical Site
      • Seville, Spanien, 41010
        • Clinical Site
      • Ostrava, Tjekkiet, 702 00
        • Clinical Site
      • Hamburg, Tyskland, 20095
        • Clinical Site
      • Herne, Tyskland, 44649
        • Clinical Site
      • Budapest, Ungarn, 1023
        • Clinical Site
      • Budapest, Ungarn, 1027
        • Clinical Site
      • Budapest, Ungarn, 1036
        • Clinical Site
      • Szentes, Ungarn, 6600
        • Clinical Site
      • Székesfehérvár, Ungarn, 8000
        • Clinical Site
      • Veszprém, Ungarn, 8200
        • Clinical Site

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Deltageren er ≥18 år gammel;
  2. Deltageren har en bekræftet diagnose af PsA i henhold til 2006-klassifikationskriterierne for psoriasisarthritis (CASPAR) med symptomer i ≥6 måneder før screeningsbesøget;
  3. Deltageren har aktiv sygdom (defineret ved en TJC68 på ≥3 og en SJC66 på ≥3);
  4. Deltageren har enten aktuel aktiv PsO eller en hudlæge bekræftet historie med PsO;
  5. Deltager tester negativ for reumatoid faktor (RF) ved screeningsbesøget;
  6. Deltager tester negativt for anti-cykliske citrullinerede peptid (CCP) antistoffer ved screeningsbesøget;
  7. Deltageren skal efter investigators mening være en egnet kandidat til behandling med adalimumab i henhold til godkendt lokal produktinformation.

Ekskluderingskriterier:

  1. Deltager med kendt overfølsomhed over for sonelokimab eller et eller flere af dets hjælpestoffer;
  2. Deltager med kendt overfølsomhed over for adalimumab eller et eller flere af dets hjælpestoffer;
  3. Deltager, som tidligere har svigtet i anti-interleukin (IL)-17-terapi;
  4. Deltager, som tidligere har svigtet med anti-tumor nekrose faktor alfa (TNFα) terapi;
  5. Deltager, som tidligere har været udsat for mere end 2 biologiske midler af enhver type til behandling af PsA før screeningsbesøget;
  6. Deltager, som har en diagnose af kroniske inflammatoriske tilstande ud over PsO eller PsA;
  7. Deltager som har diagnosen arthritis mutilans

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: sonelokimab dosisregime 1
Forsøgspersoner, der er randomiseret til denne arm, vil modtage tildelt sonelokimab-dosisregime 1
randomiseret behandling; parallel gruppe
Andre navne:
  • M1095
Eksperimentel: sonelokimab dosisregime 2
Forsøgspersoner, der er randomiseret til denne arm, vil få tildelt sonelokimab-dosisregime 2
randomiseret behandling; parallel gruppe
Andre navne:
  • M1095
Eksperimentel: sonelokimab dosis regime 3
Forsøgspersoner, der er randomiseret til denne arm, vil få tildelt sonelokimab-dosisregime 3
randomiseret behandling; parallel gruppe
Andre navne:
  • M1095
Placebo komparator: Placebo
Forsøgspersoner randomiseret til denne arm vil modtage placebo
randomiseret behandling; parallel-gruppe
Aktiv komparator: adalimumab
Forsøgspersoner randomiseret til denne arm vil modtage adalimumab
randomiseret behandling; parallel-gruppe

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12
Tidsramme: At Week 12
The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) participant's assessment of arthritis pain (PtAAP) on a Visual Analog Scale (VAS, no pain =0 to severe pain =100); 2) participant's global assessment of disease activity (PtGADA) on a VAS (very well =0 to very poor =100); 3) physician's global assessment of disease activity (phGADA) on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) high sensitivity C-reactive protein (hs-CRP, decrease indicates improvement). A non-responder imputation (NRI) method was used for missing data.
At Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, and 8 and 12
Tidsramme: At Weeks 2, 4, 8, and 12
The ACR20 response criteria was a response of at least 20% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 20% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data. ACR20 response rate at Week 12 was analyzed as a key secondary outcome measure.
At Weeks 2, 4, 8, and 12
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 4, 8 and 12, in Participants With Psoriasis Involving at Least 3% Body Surface Area (BSA) at Baseline
Tidsramme: At Weeks 4, 8, and 12
The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI90 response was defined as greater than or equal to 90% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data. PASI90 response at Week 12 was analyzed as a key secondary outcome measure.
At Weeks 4, 8, and 12
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, and 8
Tidsramme: At Weeks 2, 4, and 8
The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data.
At Weeks 2, 4, and 8
Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Weeks 2, 4, 8, and 12
Tidsramme: At Weeks 2, 4, 8, and 12
The ACR70 response criteria was a response of at least 70% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 70% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data.
At Weeks 2, 4, 8, and 12
Percentage of Participants Achieving Minimal Disease Activity at Week 12
Tidsramme: At Week 12
Minimal disease activity was defined as meeting 5 of the following 7 criteria: tender joint count (68 joints) ≤1; swollen joint count (66 joints) ≤1; psoriasis area and severity index ≤1 or psoriasis affecting ≤1% of body surface area; PtAAP ≤15 on a VAS (0 = no pain to 100 = severe pain); PtGADA ≤20 on a VAS (0 = very well to 100 = very poor); HAQ-DI ≤0.5 (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and Leeds Enthesitis Index (LEI) ≤1 (overall score ranging from 0 to 6, with higher scores indicating greater disease severity). An NRI method was used for missing data.
At Week 12
Percentage of Participants Who Achieved a PASI75 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline
Tidsramme: At Week 12
The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI75 response was defined as greater than or 75% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data.
At Week 12
Percentage of Participants Achieving a PASI100 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline
Tidsramme: At Week 12
The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI100 response was defined as 100% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data.
At Week 12
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 12
Tidsramme: Baseline and Week 12
The mNAPSI is a tool to assess psoriatic nail involvement. Three groups of features (pitting, onycholysis, and oil-drop dyshromia and crumbling) for each fingernail are graded on a scale from 0 to 3. Four features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula) are graded as either present (1) or absent (0) in each fingernail. The total score was calculated by summing the score for each feature and each fingernail and ranged from 0 to 130, with higher scores indicating greater nail disease. A negative change from baseline indicated an improvement in nail disease.
Baseline and Week 12

Samarbejdspartnere og efterforskere

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

Sponsor

Efterforskere

  • Studieleder: MD, MoonLake Immunotherapeutics AG

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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)

13. december 2022

Primær færdiggørelse (Faktiske)

5. september 2023

Studieafslutning (Faktiske)

15. januar 2024

Datoer for studieregistrering

Først indsendt

28. november 2022

Først indsendt, der opfyldte QC-kriterier

28. november 2022

Først opslået (Faktiske)

7. december 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • M1095-PSA-201

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 .