Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Filgotinib · 11 trials · 5 indications
EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 (0 and 100 indicating no disease activity and maximum disease activity)participant's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain) health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions,8 components: dressing/ grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.
ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 (0 and 100 indicating no disease activity and maximum disease activity); subject's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain); health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.
Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
The CDAI score is used to quantify the symptoms of participants with Crohn's Disease (CD). The score ranges from 0 to 600. Clinical remission by CDAI was defined as a score of \< 150. A higher score indicates more severe disease.
Combined fistula response at Week 24 was defined as reduction of greater than or equal to (≥) 1 from baseline in the number of draining external perianal fistula openings that were present at baseline, and absence of fluid collections \> 1 centimeter (cm) on magnetic resonance imaging (MRI) pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Cmax is defined as the maximum observed concentration of drug.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
AUClast is defined as the concentration of drug from time zero to the last observable concentration. GS-829845 is the primary metabolite of filgotinib.
AUCinf is defined as the concentration of drug extrapolated to infinite time.
AUCinf is defined as the concentration of drug extrapolated to infinite time. GS-829845 is the primary metabolite of filgotinib.
Cmax is defined as the maximum observed concentration of drug.
Cmax is defined as the maximum observed concentration of drug. GS-829845 is the primary metabolite of filgotinib.
| Arm | Type | Description |
|---|---|---|
| Blinded Phase: Filgotinib 200 mg | EXPERIMENTAL | Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years |
| Blinded Phase: Filgotinib 100 mg | EXPERIMENTAL | Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years |
| Open Label Phase: Filgotinib 200 mg | EXPERIMENTAL | Filgotinib 200 mg for up to 6 years |
| Open Label Phase: Filgotinib 100 mg | EXPERIMENTAL | Filgotinib 100 mg for up to 6 years |
| Filgotinib 200 mg (blinded dosing) | EXPERIMENTAL | Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks |
| Filgotinib 100 mg (blinded dosing) | EXPERIMENTAL | Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks |
| Placebo (blinded dosing) | PLACEBO_COMPARATOR | Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks |
| Filgotinib 200 mg (open-label) | EXPERIMENTAL | Filgotinib 200 mg for up to 336 weeks |
| Filgotinib 100 mg (open-label) | EXPERIMENTAL | Filgotinib 100 mg for up to 336 weeks |
| Induction Study (Cohort A): Filgotinib 200 mg | EXPERIMENTAL | Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks. |
| Induction Study (Cohort A): Filgotinib 100 mg | EXPERIMENTAL | Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. |
| Induction Study (Cohort A): Placebo | PLACEBO_COMPARATOR | Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. |
| Induction Study (Cohort B): Filgotinib 200 mg | EXPERIMENTAL | Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. |
| Induction Study (Cohort B): Filgotinib 100 mg | EXPERIMENTAL | Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. |
| Induction Study (Cohort B): Placebo | PLACEBO_COMPARATOR | Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. |
| Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg | EXPERIMENTAL | Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg for an additional 47 weeks (up to Week 58). |
| Maintenance Study: Placebo From Induction Filgotinib 200 mg | PLACEBO_COMPARATOR | Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). |
| Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg | EXPERIMENTAL | Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg for an additional 47 weeks (up to Week 58). |
| Maintenance Study: Placebo From Induction Filgotinib 100 mg | PLACEBO_COMPARATOR | Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). |
| Maintenance Study: Placebo From Induction Placebo | PLACEBO_COMPARATOR | Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib for an additional 47 weeks (up to Week 58). |
| Filgotinib 200 mg | EXPERIMENTAL | Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of methotrexate (MTX) |
| Filgotinib 100 mg | EXPERIMENTAL | Filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX |
| Adalimumab | ACTIVE_COMPARATOR | Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + adalimumab 40 mg in addition to a stable dose of MTX |
| Placebo to Filgotinib 200 mg | EXPERIMENTAL | Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 200 mg to receive filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX. |
| Placebo to Filgotinib 100 mg | EXPERIMENTAL | Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 100 mg to receive filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX. |
| Placebo Never Received Filgotinib | PLACEBO_COMPARATOR | Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. |
| Filgotinib 200 mg + MTX | EXPERIMENTAL | Filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg |
| Filgotinib 100 mg + MTX | EXPERIMENTAL | Filgotinib 100 mg + placebo to match filgotinib 200 mg + MTX up to 20 mg |
| Filgotinib 200 mg Monotherapy | EXPERIMENTAL | Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match MTX |
| MTX Monotherapy | ACTIVE_COMPARATOR | Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s) |
| Lanraplenib 30 mg | EXPERIMENTAL | Participants receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieve ≥ 35% reduction in urinary protein excretion from baseline continue to receive same blinded study treatment for additional 16 weeks. Participants who did not achieve a ≥ 35% reduction in urinary protein excretion will switch treatment. After 32 weeks of blinded treatment, participants who have ≥ 35% reduction in urinary protein excretion from baseline continue their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase. |
| Lanraplenib 30 mg to Filgotinib 200 mg | EXPERIMENTAL | At Week 16, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switch treatment and receive filgotinib 200 mg + lanraplenib placebo for additional 16 weeks. At Week 32, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 can continue whichever treatment that lead to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase. |
| Filgotinib 200 mg to Lanraplenib 30 mg | EXPERIMENTAL | At Week 16, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switch treatment and receive lanraplenib 30 mg + filgotinib placebo for additional 16 weeks. At Week 32, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 can continue whichever treatment that lead to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase. |
| Sequence AB | EXPERIMENTAL | Participants will receive atorvastatin (ATV) 40 mg tablet on Day 1, followed by a washout period of 1 day, and then pravastatin (PRA) 40 mg + rosuvastatin (ROS) 10 mg tablets on Day 3 in Treatment A, Period 1. In Treatment B, Period 2 participants will receive filgotinib 200 mg tablet once daily for 11 days, with ATV 40 mg on Day 12 and PRA 40 mg + ROS 10 mg tablets on Day 14. Period 1 and Period 2 will be separated by a washout period of 3 days. |
| Sequence BA | EXPERIMENTAL | Participants will receive filgotinib 200 mg tablet once daily for 11 days, with ATV 40 mg on Day 6 and PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. In Treatment A, Period 2 participants will receive ATV 40 mg tablet on Day 18, followed by a washout period of 1 day and PRA 40 mg + ROS 10 mg tablets on Day 20. Period 1 and Period 2 will be separated by a washout period of 6 days. |
| Moderate Hepatic Impairment | EXPERIMENTAL | Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of filgotinib on Day 1. |
| Severe Hepatic Impairment | EXPERIMENTAL | Participants with severe hepatic impairment and matched healthy controls will receive a single dose of filgotinib on Day 1. |
| Mild Hepatic Impairment | EXPERIMENTAL | Participants with mild hepatic impairment and matched healthy controls will receive a single dose of filgotinib on Day 1. |
| Name | Type | Description |
|---|---|---|
| Filgotinib | DRUG | Tablet(s) administered orally once daily |
| Placebo to match filgotinib | DRUG | Tablet(s) administered orally once daily |
| Placebo | DRUG | Tablet(s) administered orally once daily |
| PTM filgotinib | DRUG | Tablet(s) administered orally once daily |
| Adalimumab | DRUG | 40 mg administered via subcutaneous injection once every two weeks |
| Placebo to match adalimumab | DRUG | Administered via subcutaneous injection once every two weeks |
| MTX | DRUG | Commercially sourced tablet(s) administered orally |
| Placebo to match MTX | DRUG | Capsule(s) administered orally once weekly |
| csDMARDs | DRUG | csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed) |
| Lanraplenib | DRUG | 30 mg tablet administered orally once daily |
| Filgotinib placebo | DRUG | Tablet administered orally once daily |
| Lanraplenib placebo | DRUG | Tablet administered orally once daily |
| Atorvastatin | DRUG | Administered as single dose tablet orally. |
| Pravastatin | DRUG | Administered as single dose tablet orally. |
| Rosuvastatin | DRUG | Administered as single dose tablet orally. |
Key Inclusion Criteria: * Males or females who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below: * Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug * OR * Have compl...
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