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ATI-450 Plus MTX im Vergleich zu Placebo Plus MTX bei Patienten mit mittelschwerer bis schwerer aktiver RA

2. September 2026 aktualisiert von: Aclaris Therapeutics, Inc.

ATI-450 Plus MTX im Vergleich zu Placebo Plus MTX bei Patienten mit mittelschwerer bis schwerer aktiver RA, die auf MTX allein unzureichend angesprochen haben

This study evaluates ATI-450 plus MTX versus placebo plus MTX in participants with moderate to severe active RA who have had an inadequate response to MTX alone.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This is a Phase 2b, randomized, multicenter, double-blind, parallel group, placebo controlled, dose ranging study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of ATI-450 plus MTX versus placebo plus MTX in participants with moderate to severe active RA who have had an inadequate response to MTX alone.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

251

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Bulgarien
      • Pleven, Bulgarien, 5800
        • Aclaris Investigational Site
      • Plovdiv, Bulgarien, 4000
        • Aclaris Investigational Site
      • Plovdiv, Bulgarien, 4001
        • Aclaris Investigational Site
      • Plovdiv, Bulgarien, 4002
        • Aclaris Investigational Site
      • Plovdiv, Bulgarien, 4004
        • Aclaris Investigational Site
      • Sofia, Bulgarien, 1336
        • Aclaris Investigational Site
      • Sofia, Bulgarien, 1431
        • Aclaris Investigational Site
      • Sofia, Bulgarien, 1606
        • Aclaris Investigational Site
      • Varna, Bulgarien, 9000
        • Aclaris Investigational Site
  • Polen
      • Bialystok, Polen, 15-297
        • Aclaris Investigational Site
      • Bialystok, Polen, 15-879
        • Aclaris Investigational Site
      • Dąbrówka, Polen, 62-069
        • Aclaris Investigational Site
      • Krakow, Polen, 30-363
        • Aclaris Investigational Site
      • Lublin, Polen, 20-607
        • Aclaris Investigational Site
      • Nowa Sól, Polen, 67-100
        • Aclaris Investigational Site
      • Poznan, Polen, 60-218
        • Aclaris Investigational Site
      • Poznan, Polen, 60-446
        • Aclaris Investigational Site
      • Poznan, Polen, 61-397
        • Aclaris Investigational Site
      • Sochaczew, Polen, 96-500
        • Aclaris Investigational Site
      • Torun, Polen, 87-100
        • Aclaris Investigational Site
      • Warsaw, Polen, 04-141
        • Aclaris Investigational Site
      • Wroclaw, Polen, 52-442
        • Aclaris Investigational Site
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polen, 30-002
        • Aclaris Investigational Site
    • Lubelski
      • Tomaszów Lubelski, Lubelski, Polen, 22-600
        • Aclaris Investigational Site
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-362
        • Aclaris Investigational Site
    • Masovian Voivodeship
      • Nadarzyn, Masovian Voivodeship, Polen, 05-830
        • Aclaris Investigational Site
    • Mzowieckie
      • Grodzisk Mazowiecki, Mzowieckie, Polen, 05-825
        • Aclaris Investigational Site
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polen, 15-351
        • Aclaris Investigational Site
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polen, 40-282
        • Aclaris Investigational Site
    • Warm.Maz.
      • Elblag, Warm.Maz., Polen, 82-300
        • Aclaris Investigational Site
    • Warmińsko-Mazurskien
      • Olsztyn, Warmińsko-Mazurskien, Polen, 10-117
        • Aclaris Investigational Site
    • Wielkopolska
      • Poznan, Wielkopolska, Polen, 61-113
        • Aclaris Investigational Site
  • Tschechien
      • Brno, Tschechien, 615 00
        • Aclaris Investigational Site
      • Hlučín, Tschechien, 748 01
        • Aclaris Investigational Site
      • Ostrava, Tschechien, 702 00
        • Aclaris Investigational Site
      • Pardubice, Tschechien, 530 02
        • Aclaris Investigational Site
      • Prague, Tschechien, 128 50
        • Aclaris Investigational Site
      • Prague, Tschechien, 140 00
        • Aclaris Investigational Site
      • Uherské Hradiště, Tschechien, 686 01
        • Aclaris Investigational Site
  • Vereinigte Staaten
    • California
      • El Cajon, California, Vereinigte Staaten, 92020
        • Aclaris Investigational Site
      • Encino, California, Vereinigte Staaten, 91436
        • Aclaris Investigational Site
      • La Jolla, California, Vereinigte Staaten, 92093
        • Aclaris Investigational Site
      • Palm Desert, California, Vereinigte Staaten, 92260
        • Aclaris Investigational Site
    • Florida
      • Tampa, Florida, Vereinigte Staaten, 33613
        • Aclaris Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73103
        • Aclaris Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Vereinigte Staaten, 16635
        • Aclaris Investigational Site
    • Tennessee
      • Jackson, Tennessee, Vereinigte Staaten, 38305
        • Aclaris Investigational Site
    • Texas
      • Cypress, Texas, Vereinigte Staaten, 77429
        • Aclaris Investigational Site
      • Mesquite, Texas, Vereinigte Staaten, 75150
        • Aclaris Investigational Site
      • San Antonio, Texas, Vereinigte Staaten, 78229
        • Aclaris Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Able to comprehend and be willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved participant ICF prior to administration of any study-related procedures.
  • Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
  • Have active moderate to severe RA at Screening.
  • A minimum of 12 weeks on MTX with a stable MTX dose.

Exclusion Criteria:

  • Current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA.
  • Uncontrolled non-immunoinflammatory disease that may place the participant at increased risk during the study or impact the interpretation of results (eg, previous malignancy, recurrent infection, previous venous thromboembolism).
  • Participant has experience with > 2 biologics, > 1 JAK inhibitor, or a combination of 1 biologic experience and 1 JAK inhibitor.
  • Currently receiving corticosteroids at doses > 10 mg/day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of screening.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: ATI-450 20 mg BID plus Methotrexate

ATI-450 20 mg oral tablet twice daily (BID) with a stable weekly dose of methotrexate for 12 weeks
Arzneimittel: Methotrexate

15 mg to 25 mg weekly

Arzneimittel: ATI-450 20 mg oral tablet BID

Oral, small molecule MK2 inhibitor

Andere Namen:
  • Zunsemetinib
Experimental: ATI-450 50 mg BID plus Methotrexate

ATI-450 50 mg oral tablet BID with a stable weekly dose of methotrexate for 12 weeks
Arzneimittel: Methotrexate

15 mg to 25 mg weekly

Arzneimittel: ATI-450 50 mg oral tablet BID

Oral, small molecule MK2 inhibitor

Andere Namen:
  • Zunsemetinib
Placebo-Komparator: Placebo plus Methotrexate

Placebo oral tablet BID with a stable weekly dose of methotrexate for 12 weeks
Arzneimittel: Methotrexate

15 mg to 25 mg weekly

Arzneimittel: Placebo oral tablet

Placebo tablet manufactured to match ATI-450 in appearance

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Achieving ACR20 at Week 12
Zeitfenster: Week 12

Participants achieving American College of Rheumatology (ACR) 20 (responders) were defined as having ≥20% improvement in both the number of swollen and tender joints (66/68 joint counts) and ≥20% improvement in ≥3 of the following 5 measures: Patient's Global Assessment of Disease Activity (VAS), Patient's Assessment of Arthritis Pain (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician's Global Assessment of Disease Activity (VAS), and acute phase reactant as measured by hsCRP.

Model-based estimates and 95% confidence intervals (CIs) were produced.
Week 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
ATI-450- und Metaboliten-(CDD-2164)-Konzentrationen
Zeitfenster: 2 Stunden nach der Dosis an Tag 1, 8 und 85
2 Stunden nach der Dosis an Tag 1, 8 und 85
Percentage of Participants Achieving ACR50 at Week 12
Zeitfenster: Week 12

Participant achieving ACR50 (responders) were defined as having ≥50% improvement in both the number of swollen and tender joints (66/68 joint counts) and ≥50% improvement in ≥3 of the following 5 measures: Patient's Global Assessment of Disease Activity (VAS), Patient's Assessment of Arthritis Pain (VAS), HAQ-DI, Physician's Global Assessment of Disease Activity (VAS), Acute phase reactant as measured by hsCRP.

Model-based estimates and 95% CIs were produced.
Week 12
Percentage of Participants Achieving ACR70 at Week 12
Zeitfenster: Week 12

Participants achieving ACR70 (responders) were defined as having ≥70% improvement in both the number of swollen and tender joints (66/68 joint counts) and ≥70% improvement in ≥3 of the following 5 measures: Patient's Global Assessment of Disease Activity (VAS), Patient's Assessment of Arthritis Pain (VAS), HAQ-DI, Physician's Global Assessment of Disease Activity (VAS), Acute phase reactant as measured by hsCRP.

Model-based estimates and 95% CIs were produced.
Week 12
Change From Baseline in DAS28-CRP at Week 12
Zeitfenster: Baseline, Week 12

The DAS28-CRP consists of a composite score of the following variables: TJC28, SJC28, CRP (hsCRP was used for the purposes of this study), and Patient's Global Assessment of Disease Activity. Interpretation of the DAS28-CRP is on a scale of 0 to 9.4, where <2.6 is considered remission, ≥2.6 to <3.2 is considered low/minimal disease activity, ≥3.2 to ≤5.1 is considered moderate disease activity, and >5.1 is considered high/severe disease activity.

The least square (LS) mean change from baseline in DAS28-CRP at Week 12 was estimated from the Mixed Model Repeated Measures (MMRM) model.
Baseline, Week 12
Percentage of Participants Achieving DAS28-CRP Remission (Score <2.6) at Week 12
Zeitfenster: Week 12

The Disease Activity Score using 28 Joint Count-C-reactive protein (DAS28-CRP) consists of a composite score of the following variables: TJC28, SJC28, CRP (hsCRP is used for the purposes of this study), and Patient's Global Assessment of Disease Activity. Interpretation of the DAS28-CRP is on a scale of 0 to 9.4, where <2.6 is considered remission, ≥2.6 to <3.2 is considered low/minimal disease activity, ≥3.2 to ≤5.1 is considered moderate disease activity, and >5.1 is considered high/severe disease activity.

Model-based estimates and 95% CIs were produced.
Week 12
Percentage of Participants Achieving DAS28-CRP Low Disease Activity (Score ≤ 3.2) at Week 12
Zeitfenster: Week 12

The DAS28-CRP consists of a composite score of the following variables: TJC28, SJC28, CRP (hsCRP is used for the purposes of this study), and Patient's Global Assessment of Disease Activity. Interpretation of the DAS28-CRP is on a scale of 0 to 9.4, where <2.6 is considered remission, ≥2.6 to <3.2 is considered low/minimal disease activity, ≥3.2 to ≤5.1 is considered moderate disease activity, and >5.1 is considered high/severe disease activity.

Model-based estimates and 95% CIs were produced.
Week 12
Change From Baseline in HAQ-DI Score at Week12
Zeitfenster: Baseline, Week 12

The HAQ-DI (standard disability method calculation) was utilized to assess the participant's physical function or disability according to the participant. The HAQ-DI is a 20-item, validated questionnaire used to assess the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities [errands and chores]). Responses in each functional area are scored from 0 (no difficulty) to 3 (inability to perform a ask in that area). Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3. A lower score demonstrated less disability.

LS mean change from baseline in HAQ-DI score at Week 12 was estimated from the MMRM model.
Baseline, Week 12
Change From Baseline in CDAI Score at Week 12
Zeitfenster: Baseline, Week 12

The Clinical Disease Activity Index (CDAI) was the sum of 4 outcome parameters:

  • Tender joint count out of 28 joints (TJC28)
  • Swollen joint count out of 28 joints (SJC28)
  • Patient's Global Assessment of Disease Activity; and
  • Physician's Global Assessment of Disease Activity.

Interpretation of the CDAI disease activity was measured on a scale of 0 to 76, where ≤2.8 was considered remission, >2.8 to ≤10 was considered low/minimal disease activity, >10 to ≤22 was considered moderate disease activity, and >22.0 was considered high/severe disease activity.

LS mean change from baseline in CDAI score at Week 12 was estimated from the MMRM model.
Baseline, Week 12
Percentage of Participants Achieving CDAI Remission (Score ≤ 2.8)
Zeitfenster: Week 12

The CDAI was the sum of 4 outcome parameters:

  • Tender joint count out of 28 joints (TJC28)
  • Swollen joint count out of 28 joints (SJC28)
  • Patient's Global Assessment of Disease Activity; and
  • Physician's Global Assessment of Disease Activity.

Interpretation of the CDAI disease activity was measured on a scale of 0 to 76, where ≤2.8 was considered remission, >2.8 to ≤10 was considered low/minimal disease activity, >10 to ≤22 was considered moderate disease activity, and >22.0 was considered high/severe disease activity.

Model-based estimates and 95% CIs were produced.
Week 12
Percent Change From Baseline in hsCRP Level at Week 12
Zeitfenster: Baseline, Week 12

Blood samples were evaluated to measure levels of hsCRP.
Baseline, Week 12
Change From Baseline in Short Form Health Survey SF-36 Physical Component Summary (PCS) Score at Week 12
Zeitfenster: Baseline, Week 12

The PCS is composed of 4 scales of the Short Form-36 Health Status Survey Questionnaire (SF-36) version 2 assessing physical function, role limitations caused by physical problems, bodily pain, and general health. The range of the SF-36 PCS is between 0 and 100, where higher scores represent better physical functioning.

A 2.5 to 5-point change from baseline is established as the minimum clinically-important difference for the PCS in RA participants.

LS mean change from baseline in SF-36 PCS score at Week 12 was estimated from the MMRM model.
Baseline, Week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Week 12
Zeitfenster: Baseline, Week 12

The FACIT-Fatigue is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a 4 point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0 to 52. The higher the score, the lower the fatigue level.

LS mean change from baseline in FACIT-Fatigue score at Week 12 was estimated from the MMRM model.
Baseline, Week 12

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Aclaris Therapeutics, Inc.

Ermittler

  • Studienleiter: Ajay Aggarwal, Aclaris Therapeutics, Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Februar 2022

Primärer Abschluss (Tatsächlich)

5. September 2023

Studienabschluss (Tatsächlich)

11. Oktober 2023

Studienanmeldedaten

Zuerst eingereicht

18. Februar 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. März 2022

Zuerst gepostet (Tatsächlich)

15. März 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ATI-450-RA-202
  • 2021-002860-31 (EudraCT-Nummer)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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