An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848258
• Other study ID #: 18516
• Secondary ID: J3P-MC-FTAF2022-
• Status: Recruiting
• Phase: Phase 2
• Start date: May 23, 2023
• Est. completion date: July 15, 2026

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: July 15, 2026
• Est. primary completion date: February 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• LY3871801
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Argentina	CIPREC	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Mautalen Salud e Investigación	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	CENUDIAB	Ciudad Autónoma de Buenos Aire
Argentina	Medicina Reumatológica	San Fernando	Buenos Aires
Argentina	Instituto de Alta Complejidad San Isidro	San Isidro	Buenos Aires
Czechia	Medical Plus	Uherske Hradiste	Zlínský Kraj
France	Infirmerie Protestante de Lyon	Caluire et Cuire	Rhône
France	CHD Vendee	La Roche-sur-Yon	Vendée
France	CHU Montpellier Lapeyronie Hospital	Montpellier	Hérault
France	CHU de Nice	Nice	Alpes-Maritimes
France	Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau	Nîmes	Gard
France	Centre Hospitalier Regional D'Orleans	Orléans	Centre
France	Hopitaux Universitaires Paris Centre-Hopital Cochin	Paris
France	Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche	Reims	Champagne-Ardenne
France	CHU Strasbourg-Hautepierre	Strasbourg	Alsace
Germany	Rheumazentrum Prof.Neeck MVZ	Bad Doberan	Mecklenburg-Vorpommern
Germany	Fraunhofer	Frankfurt	Hessen
Germany	HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH	Hamburg
Germany	University Hospital of Cologne	Köln	Nordrhein-Westfalen
Germany	Institut für Präventive Medizin & Klinische Forschung GbR	Magdeburg	Sachsen-Anhalt
Germany	Rheumazentrum Ratingen Studienambulanz	Ratingen	Nordrhein-Westfalen
India	Avron Hospitals	Ahmedabad	Gujarat
India	Sushruta Multispeciality Hospital & Research Centre	Hubli	Karnataka
India	All India Institute of Medical Sciences (AIIMS) - Nagpur	Nagpur	Maharashtra
India	Grant Medical Foundation - Ruby Hall Clinic	Pune	Maharashtra
India	Medipoint Hospitals Pvt. Ltd.	Pune	Maharashtra
Mexico	Investigacion y Biomedicina de Chihuahua	Chihuahua
Mexico	Hospital Aranda de La Parra	Leon	Guanajuato
Mexico	Medical Care and Research SA de CV	Merida	Yucatán
Mexico	Kohler and Milstein Research S.A. de C.V.	Mérida	Yucatán
Mexico	Biológicos Especializados	Mexico City	Distrito Federal
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	Cicmex Centro de Investigación Clínica de México	Morelia	Michoacán
Mexico	Estudios Clínicos Internacionales (ECI) - Querétaro	Querétaro
Mexico	Centro de Atención e Investigación Cardiovascular del Potosí	San Luis Potosí
Mexico	CIMAB SA de CV	Torreon	Coahuila
Slovakia	Cliniq s.r.o.	Bratislava	Bratislavský Kraj
United Kingdom	The Dudley Group NHS Foundation Trust	Dudley	England
United Kingdom	Northumbria Healthcare NHS Foundation Trust	Newcastle upon Tyne	North Tyneside
United Kingdom	New Cross Hospital	Wolverhampton
United States	Integrity Clinical Research	Doral	Florida
United States	Advanced Clinical Research of Orlando - Ocoee	Ocoee	Florida
United States	PMG Research of Salisbury	Salisbury	North Carolina
United States	Conquest Research	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Rigel Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Czechia,  France,  Germany,  India,  Mexico,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)		Baseline, Week 12
Primary	Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50		Baseline to Week 12
Secondary	Phase 2a: Percentage of Participants Achieving ACR20/50/70		Baseline to Week 12
Secondary	Phase 2b: Change from Baseline in DAS28-hsCRP		Baseline, Week 12
Secondary	Phase 2b: Percentage of Participants Achieving ACR20/70		Week 12
Secondary	Change from Baseline in Simplified Disease Activity Index (SDAI)		Baseline, Week 12
Secondary	Change from Baseline in Clinical Disease Activity Index (CDAI)		Baseline, Week 12
Secondary	Change from Baseline in ACR Core Set Values 68 Tender Joint Counts		Baseline, Week 12
Secondary	Change from Baseline in ACR Core Set Values 66 Swollen Joint Counts		Baseline, Week 12
Secondary	Change from Baseline in ACR Core Set Values Physician's Global Assessment of Disease Activity (PhGADA) Visual Analog Scale (VAS)		Baseline, Week 12
Secondary	Change from Baseline in ACR Core Set Values Patient's Global Assessment of Disease Activity (PaGADA) VAS		Baseline, Week 12
Secondary	Change from Baseline for Participant's Assessment of Arthritis Pain (VAS)		Baseline, Week 12
Secondary	Change from Baseline for Participant's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI)		Baseline, Week 12
Secondary	Change from Baseline the Duration and Severity of Morning Joint Stiffness		Baseline, Week 12
Secondary	Change from Baseline for Short Form-36 (SF-36) Physical Component Summary Score		Baseline, Week 12
Secondary	Change from Baseline for SF-36 Mental Component Summary Score		Baseline, Week 12
Secondary	Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801		Baseline through Week 20

External Links

•   An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis