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Undersøgelse af XmAb942 hos raske deltagere og deltagere med colitis ulcerosa

28. oktober 2026 opdateret af: Xencor, Inc.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Participants Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of XmAb942 in Participants With Moderate-To-Severe Active Ulcerative Colitis.

The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study consists of 3 parts, as follows:

Part A: Single ascending dose (SAD) in healthy volunteer participants, will entail administration of XmAb942 or matching placebo at 3 different dose levels of XmAb942.

Part B: Multiple ascending dosing for up to 3 doses, will entail administration of XmAb942 or matching placebo at 2 different dose levels of XmAb942.

Part C: Participants with moderately to severely active UC to receive 3 different dose levels of XmAb942 or placebo during a 12-week induction period and single dose level of XmAb942 during a 40-week maintenance period, followed by a 36 follow-up period.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

270

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C425BGC
        • Rekruttering
        • Xencor Investigative Site
      • Buenos Aires, Argentina, 1643
        • Rekruttering
        • Xencor Investigative Site
      • Buenos Aires, Argentina, B1878
        • Rekruttering
        • Xencor Investigative Site
      • Rosario, Argentina, S2000
        • Rekruttering
        • Xencor Investigative Site
      • San Miguel de Tucumán, Argentina, 4000
        • Rekruttering
        • Xencor Investigative Site
  • Australien
      • Adelaide, Australien, 5000
        • Rekruttering
        • Xencor Investigative Site
      • Brisbane, Australien, 4102
        • Rekruttering
        • Xencor Investigative Site
      • Joondalup, Australien, 6027
        • Afsluttet
        • Xencor Investigative Site
      • Macquarie Park, Australien, 2019
        • Rekruttering
        • Xencor Investigative Site
      • Melbourne, Australien, 3004
        • Rekruttering
        • Xencor Investigative Site
      • Nedlands, Australien, 6009
        • Afsluttet
        • Xencor Investigative Site
      • South Brisbane, Australien, 4101
        • Rekruttering
        • Xencor Investigative Site
      • Southport, Australien, 4215
        • Rekruttering
        • Xencor Investigative Site
      • Wollongong, Australien, 2500
        • Rekruttering
        • Xencor Investigative Site
  • Brasilien
      • Campinas, Brasilien, 13092-133
        • Rekruttering
        • Xencor Investigative Site
      • Caxias do Sul, Brasilien, 95070-560
        • Rekruttering
        • Xencor Investigative Site
      • Fortaleza, Brasilien, 60430-372
        • Rekruttering
        • Xencor Investigative Site
      • Macaé, Brasilien, 27 910-190
        • Rekruttering
        • Xencor Investigative Site
      • Porto Alegre, Brasilien, 90035-903
        • Rekruttering
        • Xencor Investigative Site
      • Salvador, Brasilien, 41 820-020
        • Rekruttering
        • Xencor Investigative Site
      • Santo André, Brasilien, 09080-110
        • Rekruttering
        • Xencor Investigative Site
      • São Paulo, Brasilien, 04543-011
        • Rekruttering
        • Xencor Investigative Site
      • São Paulo, Brasilien, 01307-000
        • Rekruttering
        • Xencor Investigative Site
      • Votuporanga, Brasilien, 15500-269
        • Rekruttering
        • Xencor Investigative Site
  • Bulgarien
      • Sofia, Bulgarien, 1618
        • Rekruttering
        • Xencor Investigative Site
  • Canada
      • London, Canada, N6K 1M5
        • Rekruttering
        • Xencor Investigative Site
      • Montreal, Canada, H3H 1EB
        • Rekruttering
        • Xencor Investigative Site
      • Scarborough, Canada, M1S4T7
        • Rekruttering
        • Xencor Investigative Site
      • Vancouver, Canada, V6Z 2K5
        • Rekruttering
        • Xencor Investigative Site
  • Chile
      • Santiago, Chile, 8320000
        • Rekruttering
        • Xencor Investigative Site
  • Forenede Stater
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85255
        • Rekruttering
        • Xencor Investigative Site
    • California
      • Palo Alto, California, Forenede Stater, 94301
        • Rekruttering
        • Xencor Investigative Site
    • Florida
      • Bradenton, Florida, Forenede Stater, 34209
        • Rekruttering
        • Xencor Investigative Site
      • Brandon, Florida, Forenede Stater, 33511
        • Rekruttering
        • Xencor Investigative Site
      • Jacksonville, Florida, Forenede Stater, 32258
        • Rekruttering
        • Xencor Investigative Site
      • Kissimmee, Florida, Forenede Stater, 34741
        • Rekruttering
        • Xencor Investigative Site
      • Margate, Florida, Forenede Stater, 33063
        • Rekruttering
        • Xencor Investigative Site
      • Palmetto Bay, Florida, Forenede Stater, 33176
        • Rekruttering
        • Xencor Investigative Site
      • Tampa, Florida, Forenede Stater, 33613
        • Rekruttering
        • Xencor Investigative Site
      • Tampa, Florida, Forenede Stater, 33612
        • Rekruttering
        • Xencor Investigative Site
      • Tampa, Florida, Forenede Stater, 33615
        • Rekruttering
        • Xencor Investigative Site
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40218
        • Rekruttering
        • Xencor Investigative Site
    • Mississippi
      • Oxford, Mississippi, Forenede Stater, 38655
        • Rekruttering
        • Xencor Investigative Site
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Rekruttering
        • Xencor Investigative Site
    • New York
      • Albany, New York, Forenede Stater, 12206
        • Rekruttering
        • Xencor Investigative Site
      • Rochester, New York, Forenede Stater, 14618
        • Rekruttering
        • Xencor Investigative Site
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27612
        • Rekruttering
        • Xencor Investigative Site
    • Ohio
      • Beavercreek, Ohio, Forenede Stater, 45440
        • Rekruttering
        • Xencor Investigative Site
    • Tennessee
      • Cordova, Tennessee, Forenede Stater, 38018
        • Rekruttering
        • Xencor Investigative Site
    • Texas
      • Cedar Park, Texas, Forenede Stater, 78613
        • Rekruttering
        • Xencor Investigative Site
      • Denton, Texas, Forenede Stater, 76201
        • Rekruttering
        • Xencor Investigative Site
      • Garland, Texas, Forenede Stater, 75044
        • Rekruttering
        • Xencor Investigative Site
      • Georgetown, Texas, Forenede Stater, 78628
        • Rekruttering
        • Xencor Investigative Site
      • Houston, Texas, Forenede Stater, 77090
        • Rekruttering
        • Xencor Investigative Site
      • Houston, Texas, Forenede Stater, 77024
        • Rekruttering
        • Xencor Investigative Site
      • Kingwood, Texas, Forenede Stater, 77339
        • Rekruttering
        • Xencor Investigative Site
      • Lubbock, Texas, Forenede Stater, 79424
        • Rekruttering
        • Xencor Investigative Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Rekruttering
        • Xencor Investigative Site
      • Tyler, Texas, Forenede Stater, 75701
        • Rekruttering
        • Xencor Investigative Site
      • Webster, Texas, Forenede Stater, 77598
        • Rekruttering
        • Xencor Investigative Site
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23229
        • Rekruttering
        • Xencor Investigative Site
  • Georgien
      • Tbilisi, Georgien, 0112
        • Rekruttering
        • Xencor Investigative Site
  • Grækenland
      • Athens, Grækenland, 10676
        • Rekruttering
        • Xencor Investigative Site
      • Heraklion, Grækenland, 71500
        • Rekruttering
        • Xencor Investigative Site
      • Thessaloniki, Grækenland, 54642
        • Rekruttering
        • Xencor Investigative Site
  • Jordan
      • Amman, Jordan, 11196
        • Rekruttering
        • Xencor Investigative Site
      • Amman, Jordan, 11942
        • Rekruttering
        • Xencor Investigative Site
      • Irbid, Jordan, 21110
        • Rekruttering
        • Xencor Investigative Site
  • Kroatien
      • Osijek, Kroatien, 31000
        • Rekruttering
        • Xencor Investigative Site
      • Rijeka, Kroatien, 51000
        • Rekruttering
        • Xencor Investigative Site
      • Zagreb, Kroatien, 10000
        • Rekruttering
        • Xencor Investigative Site
  • Libanon
      • Beirut, Libanon, 0295
        • Rekruttering
        • Xencor Investigative Site
      • Beirut, Libanon, 1100-2807
        • Rekruttering
        • Xencor Investigative Site
      • Beirut, Libanon, 1100
        • Rekruttering
        • Xencor Investigative Site
      • Tripoli, Libanon, 1434
        • Rekruttering
        • Xencor Investigative Site
  • Moldova
      • Chisinau, Moldova
        • Rekruttering
        • Xencor Investigative Site
  • Polen
      • Bydgoszcz, Polen, 85-079
        • Rekruttering
        • Xencor Investigative Site
      • Katowice, Polen, 40-748
        • Rekruttering
        • Xencor Investigative Site
      • Krakow, Polen, 30-363
        • Rekruttering
        • Xencor Investigative Site
      • Nowy Targ, Polen, 34-400
        • Rekruttering
        • Xencor Investigative Site
      • Sopot, Polen, 81-756
        • Rekruttering
        • Xencor Investigative Site
      • Staszów, Polen, 28-200
        • Rekruttering
        • Xencor Investigative Site
      • Szczecin, Polen, 71-685
        • Rekruttering
        • Xencor Investigative Site
      • Warsaw, Polen, 004-501
        • Rekruttering
        • Xencor Investigative Site
      • Warsaw, Polen, 00-189
        • Rekruttering
        • Xencor Investigative Site
      • Warsaw, Polen, 03-580
        • Rekruttering
        • Xencor Investigative Site
      • Wroclaw, Polen, 52-416
        • Rekruttering
        • Xencor Investigative Site
      • Wroclaw, Polen, 53-611
        • Rekruttering
        • Xencor Investigative Site
  • Portugal
      • Loures, Portugal, 2674-514
        • Rekruttering
        • Xencor Investigative Site
  • Rumænien
      • Bragadiru, Rumænien, 400006
        • Rekruttering
        • Xencor Investigative Site
      • Bucharest, Rumænien, 020125
        • Rekruttering
        • Xencor Investigative Site
      • Bucharest, Rumænien, 021967
        • Rekruttering
        • Xencor Investigative Site
      • Cluj-Napoca, Rumænien, 400006
        • Rekruttering
        • Xencor Investigative Site
      • Ploieşti, Rumænien, 100032
        • Rekruttering
        • Xencor Investigative Site
      • Timișoara, Rumænien, 300002
        • Rekruttering
        • Xencor Investigative Site
    • District 1
      • Bucharest, District 1, Rumænien, 01-1658
        • Rekruttering
        • Xencor Investigative Site
  • Spanien
      • Barcelona, Spanien, 08022
        • Rekruttering
        • Xencor Investigative Site
      • Valencia, Spanien, 46026
        • Rekruttering
        • Xencor Investigative Site
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76008
        • Rekruttering
        • Xencor Investigative Site
      • Kyiv, Ukraine, 01135
        • Rekruttering
        • Xencor Investigative Site
      • Kyiv, Ukraine, 02091
        • Rekruttering
        • Xencor Investigative Site
      • Lutsk, Ukraine, 43005
        • Rekruttering
        • Xencor Investigative Site
      • Lviv, Ukraine, 79000
        • Rekruttering
        • Xencor Investigative Site
      • Lviv, Ukraine, 79059
        • Rekruttering
        • Xencor Investigative Site
      • Lviv, Ukraine, 79010
        • Rekruttering
        • Xencor Investigative Site
      • Uzhhorod, Ukraine, 88000
        • Rekruttering
        • Xencor Investigative Site
      • Vinnytsia, Ukraine, 21028
        • Rekruttering
        • Xencor Investigative Site
      • Vinnytsia, Ukraine, 21009
        • Rekruttering
        • Xencor Investigative Site
      • Zhytomyr, Ukraine, 10001
        • Rekruttering
        • Xencor Investigative Site
  • Ungarn
      • Budapest, Ungarn, 1136
        • Rekruttering
        • Xencor Investigative Site
      • Budapest, Ungarn, 1139
        • Rekruttering
        • Xencor Investigative Site
      • Budapest, Ungarn, 1066
        • Rekruttering
        • Xencor Investigative Site
      • Nyíregyháza, Ungarn, H-4405
        • Rekruttering
        • Xencor Investigative Site
      • Vác, Ungarn, 2600
        • Rekruttering
        • Xencor Investigative 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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Parts A and B

  • Age 18-55
  • Must be in good health with no significant medical history
  • Clinical laboratory values within normal range
  • BMI 18-35 (inclusive)
  • Contraceptive use by men or women consistent with local regulations
  • Able and willing to provide written informed consent

Part C

  • Age 18-75
  • Must be in good health with no significant medical history
  • UC diagnosis ≥ 3 months prior to screening
  • Diagnosis of moderately to severely active UC as defined by a (MMS) ≥ 5, with a MES ≥ 2 and RBS ≥ 1
  • Evidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopy
  • Must have inadequate response to, loss of response to, or intolerance to at least 1 of the conventional or advanced therapies of UC
  • Able and willing to provide written informed consent

Exclusion Criteria:

Parts A and B

  • Any physical or psychological condition that prohibits study completion
  • History of suicidal behavior or suicidal ideation
  • Heavy use of nicotine containing products
  • HIV, hepatitis B and hepatitis C positive
  • Cardiac arrhythmia, or clinically significant abnormal ECG
  • Active use of prescription medications within 14 days of Day -1
  • Active use of over-the-counter, or herbal medication within 7 days of Screening
  • Other investigational products within 30 days
  • Blood or plasma donation within 60 days
  • Pregnant or breastfeeding

Part C

  • Any physical or psychological condition that prohibits study participation
  • Diagnosis of Crohn disease, indeterminate colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis.
  • Positive screen for Clostridium difficile (C. Difficile) toxins
  • HIV, hepatitis B and hepatitis C positive
  • Cardiac arrhythmia, or clinically significant abnormal ECG
  • Pregnant or breastfeeding

Other protocol defined inclusion/exclusion criteria apply.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Part A: Active drug

Active XmAb942 to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels of XmAb942 via SC (3 cohorts) or IV (3 cohorts) administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo.
Biologisk: XmAb942

Antibody
Placebo komparator: Part A: Placebo

Placebo Comparator to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels will be randomized in a 3:1 ratio to active or placebo.
Medicin: Placebo

Placebo
Aktiv komparator: Part B: Active

Active XmAb942 to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels of XmAb942 via IV administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo.
Biologisk: XmAb942

Antibody
Placebo komparator: Part B: Placebo

Placebo Comparator to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels will be randomized in a 3:1 ratio to active or placebo.
Medicin: Placebo

Placebo
Aktiv komparator: Part C: Active

Active XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis
Biologisk: XmAb942

Antibody
Placebo komparator: Part C: placebo

Placebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis
Medicin: Placebo

Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forekomst, art og sværhedsgrad af behandlingsrelaterede bivirkninger (TEAEs) og alvorlige bivirkninger (SAEs) af XmAb942 hos raske frivillige (Del A)
Tidsramme: 20 uger
20 uger
Forekomst, karakter og sværhedsgrad af behandlingsrelaterede bivirkninger (TEAEs) og alvorlige bivirkninger (SAEs) ved XmAb942 hos raske forsøgspersoner (Del B)
Tidsramme: 28 uger
28 uger
Clinical remission based on modified mayo score (MMS), defined as MMS ≤ 2 with Mayo endoscopic score (MES) of 1, rectal bleeding subscore (RBS) of 0, and stool frequency subscore (SFS) of 0-1.
Tidsramme: 12 weeks

A composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9. It is calculated by adding the results from Mayo endoscopic subscore (MES) which measures GI bleeding, stool frequency subscore (SFS) which measures stool frequency per day, and rectal bleeding subscore (RBS), which measures presence of blood during stool passing. Each subscore is a scale of increasing severity from 0 to 3.
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forekomst og sværhedsgrad af behandlingsrelaterede bivirkninger (TEAEs) og alvorlige bivirkninger (SAEs) (Del C)
Tidsramme: 72 uger
72 uger
Ophør på grund af TEAE'er (Del C)
Tidsramme: 72 uger
72 uger
Histologisk forbedring bestemt ved ændring i Robarts Histopatologi Index (RHI) scores, som spænder fra 0 (ingen sygdomsaktivitet) til 33 (svær sygdomsaktivitet).
Tidsramme: 12 uger
12 uger
Endoskopisk forbedring defineret som (MES) på 0 eller 1 (Del C).
Tidsramme: 12 uger
12 uger
Ændring fra baseline i MS (Del C).
Tidsramme: 12 uger
12 uger
Klinisk respons baseret på MMS-score (Del C) defineret som fald fra baseline i MMS på ≥ 2 point og mindst 30 % reduktion fra baseline, samt fald på ≥ 1 point i RBS fra baseline eller absolut RBS ≤ 1
Tidsramme: 12 uger
12 uger
Serum PK parameters of XmAb942 in Healthy Volunteers (Part A)
Tidsramme: up to 20 weeks

• Cmax (Maximum concentration of drug)
up to 20 weeks
Serum PK parameters of XmAb942 in Healthy Volunteers (Part A)
Tidsramme: up to 20 weeks

• AUC0-last (Area under the curve drug concentration-time curve to last concentration)
up to 20 weeks
Serum PK parameters of XmAb942 in Healthy Volunteers (Part B)
Tidsramme: up to 28 weeks

• Cmax (Maximum concentration of drug)
up to 28 weeks
Serum PK parameters of XmAb942 in Healthy Volunteers (Part B)
Tidsramme: up to 28 weeks

• AUC0-tau AUC within a dosing interval, calculated using the linear trapezoidal rule
up to 28 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Xencor, Inc.

Efterforskere

  • Studieleder: 942 Study Information, Xencor, Inc.

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)

10. oktober 2024

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. maj 2030

Datoer for studieregistrering

Først indsendt

20. september 2024

Først indsendt, der opfyldte QC-kriterier

25. september 2024

Først opslået (Faktiske)

1. oktober 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • XmAb942-01 (G942-101)

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 .

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