Clinical trial NCT05848258: An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
Official title: An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Rigel Pharmaceuticals
First posted: 2023-05-08
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of adult-onset RA for at least 3 months prior to screening as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.
* Have moderately-to-severely active RA at screening and baseline, defined by the presence of

  * ≥6 swollen joints based on 66 joint count, and
  * ≥6 tender joints based on 68 joint count.
* Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 1 conventional synthetic disease modifying anti rheumatic drug (csDMARD) and either 1 biologic (bDMARD), or targeted synthetic (tsDMARD) treatment.

Exclusion Criteria:

* Have Class IV RA according to ACR revised criteria
* Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to

  * poorly controlled diabetes or hypertension
  * chronic kidney disease stage IIIa or IIIb, IV, or V
  * symptomatic heart failure according to New York Heart Association class II, III, or IV
  * myocardial infarction,unstable angina pectoris, stroke, or transient ischemic attack within the past 12 months before randomization
  * severe chronic pulmonary disease, for example, requiring oxygen therapy
  * major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to

    * systemic lupus erythematosus
    * psoriatic arthritis
    * axial spondyloarthritis,including ankylosing spondylitis and non-radiographic axial spondyloarthritis
    * reactive arthritis
    * gout
    * scleroderma
    * polymyositis
    * dermatomyositis
    * active fibromyalgia, or
    * multiple sclerosis

Primary outcomes:
measure: Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
timeFrame: Baseline, Week 12
measure: Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Phase 2a: Percentage of Participants Achieving ACR20/50/70
timeFrame: Baseline to Week 12
measure: Phase 2b: Change from Baseline in DAS28-hsCRP
timeFrame: Baseline, Week 12
measure: Phase 2b: Percentage of Participants Achieving ACR20/70
timeFrame: Week 12
measure: Change from Baseline in Simplified Disease Activity Index (SDAI)
timeFrame: Baseline, Week 12
measure: Change from Baseline in Clinical Disease Activity Index (CDAI)
timeFrame: Baseline, Week 12
measure: Change from Baseline in ACR Core Set Values 68 Tender Joint Counts
timeFrame: Baseline, Week 12
measure: Change from Baseline in ACR Core Set Values 66 Swollen Joint Counts
timeFrame: Baseline, Week 12
measure: Change from Baseline in ACR Core Set Values Physician's Global Assessment of Disease Activity (PhGADA) Visual Analog Scale (VAS)
timeFrame: Baseline, Week 12
measure: Change from Baseline in ACR Core Set Values Patient's Global Assessment of Disease Activity (PaGADA) VAS
timeFrame: Baseline, Week 12
measure: Change from Baseline for Participant's Assessment of Arthritis Pain (VAS)
timeFrame: Baseline, Week 12
measure: Change from Baseline for Participant's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline, Week 12
measure: Change from Baseline the Duration and Severity of Morning Joint Stiffness
timeFrame: Baseline, Week 12
measure: Change from Baseline for Short Form-36 (SF-36) Physical Component Summary Score
timeFrame: Baseline, Week 12
measure: Change from Baseline for SF-36 Mental Component Summary Score
timeFrame: Baseline, Week 12
measure: Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801
timeFrame: Baseline through Week 20
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group
state: California
city: Doral
country: United States
facility: Integrity Clinical Research
state: Florida
city: Ocoee
country: United States
facility: Advanced Clinical Research of Orlando - Ocoee
state: Florida
city: Weston
country: United States
facility: Encore Medical Research - Weston
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Willowbrook
country: United States
facility: Willow Rheumatology and Wellness PLLC
state: Illinois
city: Lake Charles
country: United States
facility: Accurate Clinical Research, Inc
state: Louisiana
city: Brooklyn
country: United States
facility: Joseph S. and Diane H. Steinberg Ambulatory Care Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Salisbury
country: United States
facility: Accellacare - Salisbury
state: North Carolina
city: Houston
country: United States
facility: Accurate Clinical Research, Inc
state: Texas
city: Bellevue
country: United States
facility: Overlake Arthritis and Osteoporosis Center
state: Washington
city: San Fernando
country: Argentina
facility: Medicina Reumatológica
state: Buenos Aires
city: San Isidro
country: Argentina
facility: Instituto de Alta Complejidad San Isidro
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: CENUDIAB
city: Uherske Hradiste
country: Czechia
facility: Medical Plus
state: Zlínský Kraj
city: Nice
country: France
facility: CHU de Nice
state: Alpes-Maritimes
city: Strasbourg
country: France
facility: CHU Strasbourg-Hautepierre
state: Alsace
city: Orléans
country: France
facility: Centre Hospitalier Regional D'Orleans
state: Centre
city: Reims
country: France
facility: Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
state: Champagne-Ardenne
city: Montpellier
country: France
facility: CHU Montpellier Lapeyronie Hospital
state: Hérault
city: La Roche-sur-Yon
country: France
facility: CHD Vendee
state: Vendée
city: Paris
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln
state: Nordrhein-Westfalen
city: Hamburg
country: Germany
facility: HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
city: Encs
country: Hungary
facility: CRU Hungary Kft.
state: Borsod-Abaúj-Zemplén
city: Szekesfehervar
country: Hungary
facility: Regia Med Kft
state: Fejér
city: Budapest
country: Hungary
facility: Revita Clinic
state: Pest
city: Kistarcsa
country: Hungary
facility: Kistarcsai Flor Ferenc Korhaz
state: Pest
city: Veszprem
country: Hungary
facility: Vital Medical Center
state: Veszprém City
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Budapest
country: Hungary
facility: Óbudai Egészségügyi Centrum
city: Hódmezővásárhely
country: Hungary
facility: Vásárhelyi Sárkányfű KFT
city: Raipur
country: India
facility: All India Institute of Medical Sciences
state: Chhattisgarh
city: Ahmedabad
country: India
facility: Avron Hospitals
state: Gujarat
city: Hubli
country: India
facility: Sushruta Multispeciality Hospital & Research Centre
state: Karnataka
city: Nagpur
country: India
facility: Government Medical College And Hospital - Nagpur
state: Maharashtra
city: Nagpur
country: India
facility: All India Institute of Medical Sciences (AIIMS) - Nagpur
state: Maharashtra
city: Pune
country: India
facility: Grant Medical Foundation - Ruby Hall Clinic
state: Maharashtra
city: Pune
country: India
facility: Medipoint Hospitals Pvt. Ltd.
state: Maharashtra
city: Torreon
country: Mexico
facility: CIMAB SA de CV
state: Coahuila
city: Mexico City
country: Mexico
facility: Biológicos Especializados
state: Distrito Federal
city: Leon
country: Mexico
facility: Hospital Aranda de La Parra
state: Guanajuato
city: Morelia
country: Mexico
facility: Cicmex Centro de Investigación Clínica de México
state: Michoacán
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Merida
country: Mexico
facility: Medical Care and Research SA de CV
state: Yucatán
city: Mérida
country: Mexico
facility: Kohler and Milstein Research S.A. de C.V.
state: Yucatán
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua
city: San Luis Potosí
country: Mexico
facility: Centro de Atención e Investigación Cardiovascular del Potosí
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park
state: Mazowieckie
city: Bialystok
country: Poland
facility: Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
state: Podlaskie
city: Bytom
country: Poland
facility: Nzoz Bif-Med
state: Śląskie
city: Dudley
country: United Kingdom
facility: The Dudley Group NHS Foundation Trust
state: England
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
state: Kingston Upon Hull
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: