Evaluering af Sonelokimab til behandling af patienter med aktiv psoriasisgigt
Fase 2, randomiseret, parallelgruppe, dobbeltblind, placebokontrolleret undersøgelse af Sonelokimab hos patienter med aktiv psoriasisgigt
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: MoonLake ClinicalTrial Helpdesk
- Telefonnummer: +41 41 510 8022
- E-mail: clinicalTrials@moonlaketx.com
Studiesteder
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Pleven, Bulgarien, 5800
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Pleven, Bulgarien, 5803
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Plovdiv, Bulgarien, 4002
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Plovdiv, Bulgarien, 4003
- Clinical Site
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Rousse, Bulgarien, 7002
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Sofia, Bulgarien, 1336
- Clinical Site
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Stara Zagora, Bulgarien, 6000
- Clinical Site
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Varna, Bulgarien, 9000
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Tallinn, Estland, 10128
- Clinical Site
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Tartu, Estland, 20708
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California
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Rancho Mirage, California, Forenede Stater, 92260
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Pennsylvania
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Duncansville, Pennsylvania, Forenede Stater, 16635
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Bialystok, Polen, 15-879
- Clinical Site
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Bialystok, Polen, 15-077
- Clinical Site
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Bialystok, Polen, 15-351
- Clinical Site
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Bydgoszcz, Polen, 85-065
- Clinical Site
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Bydgoszcz, Polen, 85-168
- Clinical Site
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Elblag, Polen, 82-300
- Clinical Site
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Gdynia, Polen, 81-338
- Clinical Site
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Krakow, Polen, 30-727
- Clinical Site
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Lodz, Polen, 90-242
- Clinical Site
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Nadarzyn, Polen, 05-830
- Clinical Site
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Nowa Sól, Polen, 67-100
- Clinical Site
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Olsztyn, Polen, 10-117
- Clinical Site
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Poznan, Polen, 61-113
- Clinical Site
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Sochaczew, Polen, 96-500
- Clinical Site
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Swidnica, Polen, 58-100
- Clinical Site
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Warsaw, Polen, 02-665
- Clinical Site
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Wroclaw, Polen, 52-416
- Clinical Site
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Madrid, Spanien, 28100
- Clinical Site
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Sabadell, Spanien, 8208
- Clinical Site
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Santiago de Compostela, Spanien, 15702
- Clinical Site
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Seville, Spanien, 41010
- Clinical Site
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Ostrava, Tjekkiet, 702 00
- Clinical Site
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Hamburg, Tyskland, 20095
- Clinical Site
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Herne, Tyskland, 44649
- Clinical Site
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Budapest, Ungarn, 1023
- Clinical Site
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Budapest, Ungarn, 1027
- Clinical Site
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Budapest, Ungarn, 1036
- Clinical Site
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Szentes, Ungarn, 6600
- Clinical Site
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Székesfehérvár, Ungarn, 8000
- Clinical Site
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Veszprém, Ungarn, 8200
- Clinical Site
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Deltageren er ≥18 år gammel;
- Deltageren har en bekræftet diagnose af PsA i henhold til 2006-klassifikationskriterierne for psoriasisarthritis (CASPAR) med symptomer i ≥6 måneder før screeningsbesøget;
- Deltageren har aktiv sygdom (defineret ved en TJC68 på ≥3 og en SJC66 på ≥3);
- Deltageren har enten aktuel aktiv PsO eller en hudlæge bekræftet historie med PsO;
- Deltager tester negativ for reumatoid faktor (RF) ved screeningsbesøget;
- Deltager tester negativt for anti-cykliske citrullinerede peptid (CCP) antistoffer ved screeningsbesøget;
- Deltageren skal efter investigators mening være en egnet kandidat til behandling med adalimumab i henhold til godkendt lokal produktinformation.
Ekskluderingskriterier:
- Deltager med kendt overfølsomhed over for sonelokimab eller et eller flere af dets hjælpestoffer;
- Deltager med kendt overfølsomhed over for adalimumab eller et eller flere af dets hjælpestoffer;
- Deltager, som tidligere har svigtet i anti-interleukin (IL)-17-terapi;
- Deltager, som tidligere har svigtet med anti-tumor nekrose faktor alfa (TNFα) terapi;
- Deltager, som tidligere har været udsat for mere end 2 biologiske midler af enhver type til behandling af PsA før screeningsbesøget;
- Deltager, som har en diagnose af kroniske inflammatoriske tilstande ud over PsO eller PsA;
- Deltager som har diagnosen arthritis mutilans
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: sonelokimab dosisregime 1
Forsøgspersoner, der er randomiseret til denne arm, vil modtage tildelt sonelokimab-dosisregime 1
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randomiseret behandling; parallel gruppe
Andre navne:
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Eksperimentel: sonelokimab dosisregime 2
Forsøgspersoner, der er randomiseret til denne arm, vil få tildelt sonelokimab-dosisregime 2
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randomiseret behandling; parallel gruppe
Andre navne:
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Eksperimentel: sonelokimab dosis regime 3
Forsøgspersoner, der er randomiseret til denne arm, vil få tildelt sonelokimab-dosisregime 3
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randomiseret behandling; parallel gruppe
Andre navne:
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Placebo komparator: Placebo
Forsøgspersoner randomiseret til denne arm vil modtage placebo
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randomiseret behandling; parallel-gruppe
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Aktiv komparator: adalimumab
Forsøgspersoner randomiseret til denne arm vil modtage adalimumab
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randomiseret behandling; parallel-gruppe
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12
Tidsramme: At Week 12
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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.
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At Week 12
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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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
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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.
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At Weeks 2, 4, 8, and 12
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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
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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.
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At Weeks 4, 8, and 12
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Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, and 8
Tidsramme: At Weeks 2, 4, and 8
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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.
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At Weeks 2, 4, and 8
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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
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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.
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At Weeks 2, 4, 8, and 12
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Percentage of Participants Achieving Minimal Disease Activity at Week 12
Tidsramme: At Week 12
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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.
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At Week 12
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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
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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.
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At Week 12
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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
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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.
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At Week 12
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Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 12
Tidsramme: Baseline and Week 12
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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.
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Baseline and Week 12
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: MD, MoonLake Immunotherapeutics AG
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Knoglesygdomme
- Muskuloskeletale sygdomme
- Rygmarvssygdomme
- Spondylarthropatier
- Hudsygdomme, Papulosquamous
- Spondylarthritis
- Spondylitis
- Hud- og bindevævssygdomme
- Gigt
- Ledsygdomme
- Psoriasis
- Gigt, psoriasis
- Hudsygdomme
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Adalimumab
- Sonelokimab
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- M1095-PSA-201
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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