Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lanraplenib · 3 trials · 3 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).
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 |
| 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 |
| 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...
Lanraplenib is an investigational small molecule being studied for Sjogren's Syndrome, Cutaneous Lupus Erythematosus, and Inflammatory Disease. It is in Phase 2 clinical development by Gilead Sciences, Inc. (GILD).
Lanraplenib is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker GILD. The drug is currently in Phase 2 clinical trials for immunology indications.
Lanraplenib is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for Sjogren's Syndrome, Cutaneous Lupus Erythematosus, and Inflammatory Disease.
Lanraplenib has completed three clinical trials. NCT02959138 studied pharmacokinetics in adults with impaired renal function. NCT03100942 assessed safety and efficacy in active Sjogren's Syndrome. NCT03134222 evaluated safety and efficacy in females with Cutaneous Lupus Erythematosus.
Lanraplenib is a distinct investigational drug. In clinical trials, it was studied alongside filgotinib and tirabrutinib, but those are separate compounds. No alternative names for Lanraplenib have been reported.