Clinical trial NCT05165771: Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-modifying Antirheumatic Drug(s) (bDMARDs) Treatment
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 on Background Therapy With Conventional Synthetic Disease-modifying Antirheumatic Drug(s) (csDMARDs) in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2021-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the effect of GS-5718 versus placebo for the treatment of rheumatoid arthritis (RA) as measured by change from baseline in Disease Activity Score (DAS) based on 28 joints using C-reactive protein (CRP) (DAS28\[CRP\]) at Week 12.


Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of rheumatoid arthritis (RA) ≥ 3 months prior to screening fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA
* Rheumatoid factor (RF) and/or anti-citrullinated protein antibodies (ACPA) positivity
* Individual fulfills all of the following minimum disease activity criteria:

  * ≥ 6 swollen joints (from a swollen joint count based on 66 joints \[SJC66\]) provided this would also fulfill ≥ 4 swollen joints (from a swollen joint count based on 28 joints \[SJC28\]) at screening and Day 1, and
  * ≥ 6 tender joints (from a tender joint count based on 68 joints \[TJC68\]), provided this would also fulfill ≥ 4 tender joints (from a tender joint count based on 28 joints \[TJC28\]) at screening and Day 1, and
  * hsCRP \> upper limit of normal at screening
* Received at least one bDMARD for the treatment of RA to which there is a lack of efficacy and/or intolerance.

Key Exclusion Criteria:

* Individuals who do not qualify per the tofacitinib label and/or local guidelines should not be enrolled.
* Prior exposure to any Janus kinase inhibitor

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Disease Activity Score (DAS) Based on 28 Joints Using C-reactive Protein (CRP) DAS28 (CRP) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants Who Achieve American College of Rheumatology 20% Improvement (ACR20) Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieve ACR 50% Improvement (ACR50) Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieve ACR 70% Improvement (ACR70) Response at Week 12
timeFrame: Week 12
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Who Achieve SDAI ≤ 11 at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieve CDAI ≤ 10 at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieve DAS28(CRP) ≤ 3.2 at Week 12
timeFrame: Week 12
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Who Achieve SDAI ≤ 3.3 at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieve CDAI ≤ 2.8 at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieve DAS28(CRP) < 2.6 at Week 12
timeFrame: Week 12
measure: Pharmacokinetic (PK) Parameter: AUCtau of GS-5718
timeFrame: Up to Week 12
measure: PK Parameter: AUCtau of Methotrexate (MTX)
timeFrame: Up to Week 8
measure: PK Parameter: Cmax of GS-5718
timeFrame: Up to Week 12
measure: PK Parameter: Cmax of MTX
timeFrame: Up to Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: