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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05848258
Collaborator
Rigel Pharmaceuticals (Industry)
380
Enrollment
47
Locations
6
Arms
39.1
Anticipated Duration (Months)
8.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
380 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
May 11, 2023
Anticipated Primary Completion Date :
Feb 25, 2026
Anticipated Study Completion Date :
Aug 14, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3871801 Phase 2a

Participants will receive LY3871801 administered orally.

Drug: LY3871801
Administered orally
Placebo Comparator: Placebo Phase 2a

Participants will receive placebo.

Drug: Placebo
Administered orally
Experimental: LY3871801 Dose 1 Phase 2b

Participants will receive LY3871801 administered orally.

Drug: LY3871801
Administered orally
Experimental: LY3871801 Dose 2 Phase 2b

Participants will receive LY3871801 administered orally.

Drug: LY3871801
Administered orally
Experimental: LY3871801 Dose 3 Phase 2b

Participants will receive LY3871801 administered orally.

Drug: LY3871801
Administered orally
Placebo Comparator: Placebo Phase 2b

Participants will receive placebo.

Drug: Placebo
Administered orally

Outcome Measures

Primary Outcome Measures

  1. Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP) [Baseline, Week 12]

  2. Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50 [Baseline to Week 12]

Secondary Outcome Measures

  1. Phase 2a: Percentage of Participants Achieving ACR20/50/70 [Baseline to Week 12]

  2. Phase 2b: Change from Baseline in DAS28-hsCRP [Baseline, Week 12]

  3. Phase 2b: Percentage of Participants Achieving ACR20/70 [Week 12]

  4. Change from Baseline in Simplified Disease Activity Index (SDAI) [Baseline, Week 12]

  5. Change from Baseline in Clinical Disease Activity Index (CDAI) [Baseline, Week 12]

  6. Change from Baseline in ACR Core Set Values 68 Tender Joint Counts [Baseline, Week 12]

  7. Change from Baseline in ACR Core Set Values 66 Swollen Joint Counts [Baseline, Week 12]

  8. Change from Baseline in ACR Core Set Values Physician's Global Assessment of Disease Activity (PhGADA) Visual Analog Scale (VAS) [Baseline, Week 12]

  9. Change from Baseline in ACR Core Set Values Patient's Global Assessment of Disease Activity (PaGADA) VAS [Baseline, Week 12]

  10. Change from Baseline for Participant's Assessment of Arthritis Pain (VAS) [Baseline, Week 12]

  11. Change from Baseline for Participant's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI) [Baseline, Week 12]

  12. Change from Baseline the Duration and Severity of Morning Joint Stiffness [Baseline, Week 12]

  13. Change from Baseline for Short Form-36 (SF-36) Physical Component Summary Score [Baseline, Week 12]

  14. Change from Baseline for SF-36 Mental Component Summary Score [Baseline, Week 12]

  15. Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801 [Baseline through Week 20]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Rheumatology Research Woodland Hills California United States 91364
2 Integrity Clinical Research Doral Florida United States 33122
3 Advanced Clinical Research of Orlando - Ocoee Ocoee Florida United States 34761
4 Conquest Research Winter Park Florida United States 32789
5 Accellacare - Salisbury Salisbury North Carolina United States 28144
6 Medicina Reumatológica San Fernando Buenos Aires Argentina 1646
7 Instituto de Alta Complejidad San Isidro San Isidro Buenos Aires Argentina 1642
8 Instituto de Investigaciones Clinicas Zarate Zárate Buenos Aires Argentina B2800DGH
9 Mautalen Salud e Investigación Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1128AAF
10 CENUDIAB Ciudad Autónoma de Buenos Aire Argentina C1440AAD
11 A-Shine Plzen Plzeň-měst Czechia 301 00
12 Clintrial s.r.o. Praha Praha 10 Czechia 100 00
13 Medical Plus Uherske Hradiste Zlínský Kraj Czechia 686 01
14 Centre Hospitalier Universitaire de Nice - Hopital Pasteur Nice Alpes-Maritimes France 06000
15 CHU Strasbourg-Hautepierre Strasbourg Alsace France 67098
16 Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche Reims Champagne-Ardenne France 51092
17 Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau Nîmes Gard France 30029
18 CHU Montpellier Lapeyronie Hospital Montpellier Hérault France 34295
19 Infirmerie Protestante de Lyon Caluire et Cuire Rhône France 69300
20 CHD Vendee La Roche-sur-Yon Vendée France 85000
21 Centre Hospitalier Regional D'Orleans Orléans France 45067
22 Hopitaux Universitaires Paris Centre-Hopital Cochin Paris France 75679
23 Fraunhofer Frankfurt Hessen Germany 60596
24 Rheumazentrum Prof.Neeck MVZ Bad Doberan Mecklenburg-Vorpommern Germany 18209
25 Universitaetsklinikum Koeln Köln Nordrhein-Westfalen Germany 50937
26 Rheumazentrum Ratingen Studienambulanz Ratingen Nordrhein-Westfalen Germany 40878
27 Institut für Präventive Medizin & Klinische Forschung GbR Magdeburg Sachsen-Anhalt Germany 39110
28 HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / Dr. Andrea Everding GmbH GbR Hamburg Germany 20095
29 Avron Hospitals Ahmedabad Gujarat India 380013
30 Sushruta Multispeciality Hospital & Research Centre Hubli Karnataka India 580021
31 Government Medical College And Hospital - Nagpur Nagpur Maharashtra India 440009
32 All India Institute of Medical Sciences (AIIMS) - Nagpur Nagpur Maharashtra India 441108
33 Grant Medical Foundation - Ruby Hall Clinic Pune Maharashtra India 411001
34 CIMAB SA de CV Torreon Coahuila Mexico 27000
35 Biológicos Especializados Mexico City Distrito F Mexico 06700
36 Hospital Aranda de La Parra Leon Guanajuato Mexico 37000
37 Cicmex Centro de Investigación Clínica de México Morelia Michoacán Mexico 58020
38 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 66460
39 Medical Care and Research SA de CV Merida Yucatán Mexico 97070
40 Köhler & Milstein Research Mérida Yucatán Mexico 97070
41 Estudios Clínicos Internacionales (ECI) - Querétaro Querétaro Mexico 76000
42 Centro de Atención e Investigación Cardiovascular del Potosí San Luis Potosí Mexico 78200
43 Cliniq s.r.o. Bratislava Bratislavský Kraj Slovakia 81109
44 Russells Hall Hospital Dudley England United Kingdom DY1 2HQ
45 Hull Royal Infirmary Hull Kingston Upon Hull United Kingdom HU3 2JZ
46 Northumbria Healthcare NHS Foundation Trust Newcastle upon Tyne North Tyneside United Kingdom NE29 8NH
47 New Cross Hospital Wolverhampton United Kingdom WV10 0QP

Sponsors and Collaborators

  • Eli Lilly and Company
  • Rigel Pharmaceuticals

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05848258
Other Study ID Numbers:
  • 18516
  • J3P-MC-FTAF
  • 2022-502994-40-00
First Posted:
May 8, 2023
Last Update Posted:
May 12, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid

Study Results

No Results Posted as of May 12, 2023