Recruiting NCT06972446

A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis

Phase II Interventional Rheumatoid Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Lutikizumab, Placebo, Ravagalimab.
Who it may be relevant to: Registry conditions: Rheumatoid Arthritis. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Canada, Czechia, Germany, Hungary +8
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis

Overview

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA). This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Interventions

Drug Lutikizumab
Subcutaneous (SC) injection
Drug Placebo
Subcutaneous (SC) injection
Drug Ravagalimab
Subcutaneous (SC) injection

Primary outcome measures

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response [Time frame: At Week 12]
Number of Participants with Adverse Events (AEs) [Time frame: Up to Approximately Week 22]

Secondary outcome measures (7)

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response [Time frame: At Week 12]
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response [Time frame: At Week 12]
Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP) [Time frame: At Week 12]
Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP) [Time frame: At Week 12]
Change from Baseline in DAS28 (CRP) [Time frame: At Week 12]
Percentage Of Participants Achieving LDA per Clinical Disease Activity Index (CDAI) [Time frame: At Week 12]
Percentage Of Participants Achieving CR per CDAI [Time frame: At Week 12]

Eligibility criteria

Inclusion criteria

At any time prior to the Screening Visit, participant must have been treated for > or = 3 months with at least 1 b/tsDMARD therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b/tsDMARD is 2.
Participant must be on a stable dose of methotrexate (MTX)

Exclusion criteria

Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), oral corticosteroids (equivalent to ≤ 10 mg/day of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 1 week prior to Baseline Visit.
History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

United States · 56 centers

Sun Valley Arthritis Center /ID# 278331 — Peoria
Arensia Research Clinic /ID# 280896 — Phoenix
Arthritis And Rheumatism Associates (Ara) - Jonesboro /ID# 272896 — Jonesboro
Private Practice - Dr. David S. Hallegua /ID# 277608 — Beverly Hills
Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826 — Chula Vista
Newport Huntington Medical Group /ID# 272439 — Huntington Beach
Cohen Medical Centers /ID# 278341 — Thousand Oaks
The Lundquist Institute /ID# 272481 — Torrance
… and 48 more centers

Poland · 7 centers

Medicover Integrated Clinical Services - Bydgoszcz (SMO/Network/Consortium) /ID# 272975 — Bydgoszcz
Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy /ID# 281180 — Bydgoszcz
Malopolskie Centrum Kliniczne /ID# 272965 — Krakow
Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 281209 — Krakow
Centrum Medyczne Reuma Park /ID# 272968 — Warsaw
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 2729 — Elblag
Etyka Osrodek Badan Klinicznych /ID# 272974 — Olsztyn

Puerto Rico · 7 centers

Clinical Research Investigator Group /ID# 274821 — Bayamón
… and 6 more centers

Spain · 7 centers