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Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis (Falcon)

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ClinicalTrials.gov Identifier: NCT04130919
Recruitment Status : Active, not recruiting
First Posted : October 18, 2019
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to demonstrate the efficacy of tilpisertib (formerly GS-4875) compared with placebo control in achieving clinical remission per modified Mayo Clinic score (MCS) in adults with moderately to severely active ulcerative colitis (UC).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Tilpisertib Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : December 20, 2019
Actual Primary Completion Date : February 18, 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tilpisertib 300 mg
Participants will receive blinded tilpisertib 300 mg for up to 10 weeks. An efficacy assessment will be performed at Week 10. Participants who achieve MCS response will continue on the blinded treatment for up to 50 weeks.
Drug: Tilpisertib
Tablets administered orally once daily
Other Name: GS-4875

Experimental: Tilpisertib 100 mg
Participants will receive blinded tilpisertib 100 mg for up to 10 weeks. An efficacy assessment will be performed at Week 10. Participants who achieve MCS response will continue on the blinded treatment for up to 50 weeks.
Drug: Tilpisertib
Tablets administered orally once daily
Other Name: GS-4875

Placebo Comparator: Placebo
Participants will receive blinded tilpisertib placebo for up to 10 weeks. An efficacy assessment will be performed at Week 10. Participants who achieve MCS response will continue on the blinded treatment for up to 50 weeks.
Drug: Placebo
Tablets administered orally once daily

Experimental: Open-label Treatment Phase
Based on the efficacy assessment results at Week 10, participants who do not achieve MCS response will have the option to receive open-label tilpisertib 300 mg for up to 50 weeks.
Drug: Tilpisertib
Tablets administered orally once daily
Other Name: GS-4875




Primary Outcome Measures :
  1. Percentage of Participants who Achieve Clinical Remission per Modified MCS at Week 10 [ Time Frame: Week 10 ]
    Clinical remission per modified MCS is defined as stool frequency subscore ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤ 1.


Secondary Outcome Measures :
  1. Percentage of Participants who Achieve Endoscopic Response at Week 10 [ Time Frame: Week 10 ]
    Endoscopic response is defined as an endoscopic subscore ≤ 1.

  2. Percentage of Participants who Achieve MCS Response at Week 10 [ Time Frame: Week 10 ]
    MCS response is defined as a decrease from baseline of ≥ 3 points and at least 30% in MCS, in addition to a ≥ 1 point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore ≤ 1.

  3. Percentage of Participants who Achieve MCS Remission at Week 10 [ Time Frame: Week 10 ]
    MCS remission is defined as a MCS score of ≤ 2 and no individual subscore > 1.

  4. Percentage of Participants who Achieve Histologic Remission Based Upon the Geboes Scale at Week 10 [ Time Frame: Week 10 ]

    All the following must be met for histologic remission based upon the Geboes scale:

    Grade 0 of ≤ 0.3, Grade 1 of ≤ 1.1, Grade 2a of ≤ 2A.3, Grade 2b of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Lower values represent a better outcome.


  5. Percentage of Participants Experiencing Adverse Events [ Time Frame: First dose date up to 60 weeks plus 30 days ]
  6. Percentage of Participants Experiencing Laboratory Abnormalities [ Time Frame: First dose date up to 60 weeks plus 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males, or non-pregnant, non-lactating females, at least 18 years of age based on the date of the screening visit.
  • UC of at least 3 months duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening.
  • Moderately to severely active UC as determined during screening by a centrally read endoscopy score ≥ 2, a Rectal Bleeding subscore ≥ 1, a Stool Frequency subscore ≥ 1 and Physicians Global Assessment (PGA) of ≥ 2 as defined by the Mayo Clinic Score; total MCS must be between 6 and 12, inclusive.
  • Previously demonstrated an inadequate response (primary non-response) or loss of response (secondary non-response) to a tumor necrosis factor-alpha (TNFα) inhibitor (ie, infliximab, adalimumab, golimumab, or biosimilars). The induction treatment regimen resulting in inadequate response or loss of response should have been in accordance with local prescribing information/guidelines or as outlined below.

    • Infliximab: 5 mg/kg at Weeks 0, 2, and 6
    • Adalimumab: 160 mg on Day 1 (given in 1 day or split over consecutive days), followed by 80 mg 2 weeks later (Day 15), 40 mg 2 weeks later (Day 29) and every 2 weeks thereafter until Day 57
    • Golimumab: 200 mg on Day 1 followed by 100 mg at Week 2
  • May be receiving concomitant therapy for UC at the time of enrollment as specified in the protocol, provided the dose prescribed has been stable as indicated prior to randomization.
  • Meet the following Tuberculosis (TB) screening criteria:

    • No evidence of active TB, latent TB, or inadequately treated TB as evidenced by 1 of the following:

      • A negative QuantiFERON test or equivalent assay reported by the central lab at screening or within 90 days prior to randomization date. OR
      • A history of fully treated active or latent TB according to local standard of care. Investigator must verify adequate previous anti-TB treatment and provide documentation; these individuals do not require QuantiFERON testing and eligibility must be approved by the sponsor prior to enrollment in the study. AND
      • A chest radiograph (views as per local guidelines with the report or films available for investigator review) taken at screening or within the 4 months prior to randomization without evidence of active or latent TB infection.
  • Laboratory assessments at screening within the following parameters:

    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and total bilirubin ≤ 2 X ULN (upper limit of normal)
    • Estimated glomerular filtration rate (eGFR) ≥ 60 ml/min (1.0 mL/sec) as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Cystatin C formula as described in protocol.
    • Hemoglobin ≥ 8 g/dL (≥ 80 g/L)
    • Absolute neutrophil count (ANC) ≥ 1.5 × 10^3/μL (≥ 1.5 GI/L)
    • Platelets ≥ 100 × 10^3/μL (≥ 100 GI/L)
    • White blood cells (WBC) ≥ 3 × 10^3/μL (≥ 3 GI/L)
    • Absolute lymphocyte count ≥ 0.75 × 10^3/μL (≥ 0.75 GI/L)

Exclusion Criteria:

  • Currently displaying clinical signs of acute severe colitis, fulminant colitis, or toxic megacolon.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130919


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04130919    
Other Study ID Numbers: GS-US-365-4237
2019-001430-33 ( EudraCT Number )
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases