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Also known as GS-5290
Tilpisertib Fosmecarbil · 1 trial · 1 indication
Clinical Response is defined as a decrease from baseline of ≥ 2 points and at least 30% in 3 components of the modified Mayo Clinic Score, Stool Frequency, Rectal Bleeding, and Endoscopic Findings, in addition to a ≥ 1 point decrease from baseline in the Rectal Bleeding subscore or Rectal Bleeding subscore of ≤ 1. The modified Mayo Clinic Score is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for modified Mayo Clinic Score ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.
| Arm | Type | Description |
|---|---|---|
| Tilpisertib Fosmecarbil Dose A | EXPERIMENTAL | Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil Dose A for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose A for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug. |
| Tilpisertib Fosmecarbil Dose B | EXPERIMENTAL | Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil Dose B for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose B for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug. |
| Tilpisertib Fosmecarbil Dose C | EXPERIMENTAL | Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil Dose C for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose C for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose B for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug. |
| Tilpisertib Fosmecarbil Placebo | PLACEBO_COMPARATOR | Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil placebo for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose C for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose A for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved Clinical Response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve Clinical Response at Non-responder Treatment Phase Week 12 will discontinue study drug. |
| Name | Type | Description |
|---|---|---|
| Tilpisertib Fosmecarbil | DRUG | Tablets administered orally |
| Placebo | DRUG | Tablets administered orally |
Key Inclusion Criteria: * Individuals assigned male at birth, or nonpregnant, nonlactating individuals assigned female at birth, 18 to 75 years of age based on the date of the screening visit. * Ulcerative colitis (UC) of at least 90-day duration before randomization confirmed by endoscopy and hist...
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Tilpisertib Fosmecarbil is an investigational small molecule drug being developed by Gilead Sciences for the treatment of ulcerative colitis. It is currently in Phase 2 clinical development and has not been approved by the FDA. It is designed as an inhibitor of MAP3K8.
Tilpisertib Fosmecarbil is being studied for the treatment of moderately to severely active ulcerative colitis, a gastrointestinal inflammatory condition. It is an investigational therapy in Phase 2 development and is not yet approved for any indication.
Tilpisertib Fosmecarbil targets MAP3K8, also known as TPL2, and acts as an inhibitor of this kinase. By inhibiting MAP3K8, the drug is intended to modulate inflammatory signaling pathways relevant to ulcerative colitis.
Tilpisertib Fosmecarbil is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the ongoing Phase 2 clinical program evaluating the drug in ulcerative colitis.
Tilpisertib Fosmecarbil is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 trial is currently active but not recruiting participants.
Tilpisertib Fosmecarbil is being evaluated in a single Phase 2 trial, NCT06029972, titled Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis. The trial is randomized, double-blind, placebo-controlled, and has enrolled 176 participants across multiple countries.