Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lanraplenib
GS-9876 · 4 trials · 4 indications
CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
Response was defined as: Improvement ≥ 20% in ≥ 3 of 5 participant-reported Sjogren's syndrome (SjS) related visual analogue score (VAS) measures (participant's assessment of global disease, pain, oral dryness, ocular dryness and fatigue), with no increase defined as \> 30 mm from baseline (Day 1) in any of the above 5 VAS measures, AND either ≥ 20% improvement in high sensitivity C-reactive protein (hsCRP) (if hsCRP ≥ 1.5 x upper limit of normal \[ULN\] on Day 1) or no increase in hsCRP to ≥ 1.5 x ULN (if hsCRP \< 1.5 x ULN on Day 1).
Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
AUClast is defined as the concentration of drug from time zero to the last observable concentration. CLcr was estimated using the CG equation for renal function as recommended by the FDA and international guidance documents. CG equation: For men: CLcr (mL/min) = (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) For women: CLcr (mL/min) = 0.85 × (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) Participants were classified based on estimated CLcr as: Moderate renal impairment: CLcr 30-59 mL/min Severe renal impairment: CLcr 15-29 mL/min Healthy control: CLcr ≥ 90 mL/min
AUCinf is defined as the concentration of drug extrapolated to infinite time. CLcr was estimated using the CG equation for renal function as recommended by the FDA and international guidance documents. CG equation: For men: CLcr (mL/min) = (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) For women: CLcr (mL/min) = 0.85 × (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) Participants were classified based on estimated CLcr as: Moderate renal impairment: CLcr 30-59 mL/min Severe renal impairment: CLcr 15-29 mL/min Healthy control: CLcr ≥ 90 mL/min
Cmax is defined as the maximum concentration of drug. CLcr was estimated using the CG equation for renal function as recommended by the FDA and international guidance documents. CG equation: For men: CLcr (mL/min) = (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) For women: CLcr (mL/min) = 0.85 × (\[140-age in years\] × \[body weight in kg\])/(72 × serum creatinine in mg/dL) Participants were classified based on estimated CLcr as: Moderate renal impairment: CLcr 30-59 mL/min Severe renal impairment: CLcr 15-29 mL/min Healthy control: CLcr ≥ 90 mL/min
| Arm | Type | Description |
|---|---|---|
| Lanraplenib 30 mg | EXPERIMENTAL | Lanraplenib + filgotinib placebo for 48 weeks |
| Filgotinib 200 mg | EXPERIMENTAL | Filgotinib + lanraplenib placebo for 48 weeks |
| Placebo | PLACEBO_COMPARATOR | Filgotinib placebo + lanraplenib placebo for 12 weeks |
| Placebo to Lanraplenib 30 mg | EXPERIMENTAL | After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48. |
| Placebo to Filgotinib 200 mg | EXPERIMENTAL | After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48. |
| Lanraplenib | EXPERIMENTAL | Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks. |
| Filgotinib | EXPERIMENTAL | Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks. |
| Tirabrutinib | EXPERIMENTAL | Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks. |
| Placebo, then active treatment | PLACEBO_COMPARATOR | Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48: * filgotinib + lanraplenib placebo + tirabrutinib placebo * lanraplenib + filgotinib placebo + tirabrutinib placebo * tirabrutinib + filgotinib placebo + lanraplenib placebo |
| GS-9876 - 30 mg | EXPERIMENTAL | GS-9876 30 mg + filgotinib placebo for 12 weeks |
| GS-9876 - 10 mg | EXPERIMENTAL | GS-9876 10 mg + filgotinib placebo for 12 weeks |
| Moderate Renal Impairment (Cohort 1) | EXPERIMENTAL | Participants with moderate renal impairment and matched healthy controls will receive a single dose of lanraplenib |
| Severe Renal Impairment (Adaptive Cohort 2) | EXPERIMENTAL | Participants with severe renal impairment and matched healthy controls will receive a single dose of lanraplenib |
| Mild Renal Impairment (Adaptive Cohort 3) | EXPERIMENTAL | Participants with mild renal impairment and matched healthy controls will receive a single dose of lanraplenib |
| Name | Type | Description |
|---|---|---|
| Lanraplenib | DRUG | 30 mg tablets administered orally once daily with or without food |
| Filgotinib | DRUG | 200 mg tablets administered orally once daily with or without food |
| Lanraplenib placebo | DRUG | Tablets administered orally once daily with or without food |
| Filgotinib placebo | DRUG | Tablets administered orally once daily with or without food |
| Tirabrutinib | DRUG | 1 x 40 mg tablet administered orally once daily |
| Tirabrutinib placebo | DRUG | 1 x tablet administered orally once daily |
| GS-9876 | DRUG | One tablet administered orally once daily |
| GS-9876 placebo | DRUG | One tablet administered orally once daily |
| Methotrexate | DRUG | Background therapy with methotrexate administered orally or parenterally once weekly |
| Lanraplenib. | DRUG | 20 mg (2 X 10 mg) tablets administered orally in a fasted state on Day 1 |
Key Inclusion Criteria: * Must have a diagnosis of CLE, either chronic (e.g., discoid) or subacute CLE per investigator evaluation, with the following: * Moderately-to-severely active CLE (Cutaneous lupus erythematosus disease area and severity index \[CLASI\] activity score ≥ 10) at screening a...
Top 20 of 31 competitors
GS-9876 is an investigational small molecule being studied for the treatment of active rheumatoid arthritis. It is designed to be used in combination with background methotrexate therapy. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
GS-9876 is a small molecule developed by Gilead Sciences for rheumatoid arthritis. While its specific molecular target is not publicly disclosed in the available clinical trial information, it is being evaluated for its safety, tolerability, and efficacy in patients with active disease who are on background methotrexate therapy.
GS-9876 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. The company is conducting clinical research to evaluate the drug's potential as a treatment for rheumatoid arthritis.
GS-9876 is in Phase 2 clinical development. A Phase 2 clinical trial has been completed to assess its safety, tolerability, and efficacy in participants with active rheumatoid arthritis. The drug remains investigational and is not yet approved for any use.
GS-9876 has been studied in one completed Phase 2 clinical trial, identified as NCT02885181. This randomized, double-blind, placebo-controlled trial enrolled 83 participants with active rheumatoid arthritis on background methotrexate therapy, across multiple countries including the United States, Bulgaria, Czechia, Georgia, Moldova, Poland, and Ukraine.
GS-9876 is the investigational code name used by Gilead Sciences for this small molecule. No alternative brand names or other designations have been disclosed in the clinical trial information. It is distinct from other drugs and is being evaluated specifically for rheumatoid arthritis.