Home » Trials » SLCTR/2019/002


A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

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SLCTR Registration Number

SLCTR/2019/002


Date of Registration

16 Jan 2019

The date of last modification

Aug 24, 2019


Trial Status



Application Summary


Scientific Title of Trial

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease


Public Title of Trial

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease


Disease or Health Condition(s) Studied

Crohn’s Disease


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

Registered with clinicaltrials.gov. Identifier: NCT02914600; EudraCT Number: 2016-002763-34


Trial Details


What is the research question being addressed?

How safe is filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored Filgotinib treatment study in Crohn’s Disease (SLCTR/2018/029) through the conduction of long term safety study


Type of study

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 3


Intervention(s) planned

Study sites: 1. Colombo North Teaching Hospital, Ragama. 2. Kandy Teaching Hospital, Kandy

Interventions: Subjects who exit a parent study due to disease worsening or failure to meet response or remission criteria will receive open-label 200 mg filgotinib. Subjects will receive filgotinib or placebo for up to 144 weeks. Approximately 1000 subjects who meet eligibility criteria at Day 01 will receive filgotinib or placebo.

The study medication will consist of blinded-dosing filotinib 200 mg + Placebo to match (PTM) 100 mg or 100 mg filgotinib tablets + PTM 200 mg or PTM 100 mg + PTM 200 mg. Open-label dosing of 200 mg and 100 mg filgotinib tablets for oral administration, to be taken once a day. Placebo to match (PTM) Filgotinib 200 mg and 100 mg tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, macrogol/PEG 3350, polyvinyl alcohol talc, titanium dioxide, iron oxide yellow and iron oxide red.

Standard management will be provided to the trial participants as per local guidelines


Inclusion criteria

  1. Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures associated with this trial
  2. Must have met all eligibility criteria from trial SLCTR/2018/029.
  3. Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
  4. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 6 of the protocol for the duration described
  5. Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
  6. Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for Crohn’s Disease - SLCTR/2018/029

Exclusion criteria

  1. Subjects who are discontinued from a parent study for reasons other than disease worsening, or lack of response or remission; eg, subjects who discontinue for safety or tolerability issues are not eligible for the present study. Details of discontinuation are provided as an annexure.
  2. Known hypersensitivity to the study drug
  3. Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol
  4. Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and for at least 35 days of the last dose of the study drug
  5. Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of study drug
  6. Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in Appendix 6 of the protocol
  7. Use of prohibited medications as outlined in Section 5.4 of the protocol


Primary outcome(s)

1.

Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests.

  1. Clinical parameters • Resting blood pressure • Respiratory rate • Pulse • Temperature
[

Day 1, week 2, week 4, Week 12 and then every 12 Weeks from Day 1 Clinic Visit, early termination visit, post treatment.

]
2.

Hematology and chemistry
Hematology • Hematocrit • Hemoglobin • Platelet count • Red blood cell (RBC) count • White blood cell (WBC) count • Differentials (absolute and percentage), including: • Lymphocytes • Monocytes • Neutrophils • Eosinophils • Basophils • Reticulocyte count • Mean corpuscular volume (MCV)

Chemistry • Alkaline phosphatase • Aspartate aminotransferase (AST) • Alanine aminotransferase (ALT) • Total bilirubin • Direct and indirect bilirubin • Total protein • Albumin • Bicarbonate • Blood urea nitrogen (BUN) • Calcium • Chloride • Serum creatinine • Creatinine clearance CC&G • Glucose • Phosphorus • Magnesium • Potassium • Sodium • Creatine Phosphokinase (CPK)

[

Hematology and chemistry Day 1, Week 2, Week 4, Week 12 and then every 12 weeks from Day 1 visit, Early termination visit day, Post-treatment day

]
3.

Lipid profile (fasting)

[

Every 24 weeks from Day 1 Clinic Visit

]
4.

Urinalysis

[

Day 1, Every 24 weeks from Day 1 Clinic Visit

]
5.

Pregnancy test

[

Day 1, Week 4, Every 4 weeks from Day 1,Early termination visit day, Post-treatment day

]
6.

Serum immunoglobulin

[

Day 1, Every 24 weeks from Day 1

]
7.

CRP

[

Day 1, Every 24 weeks from Day 1

]
8.

Fecal MMP-9

[

Day 1, Every 24 weeks from Day 1

]
9.

Fecal Calprotectin, and Lactoferrin

[

Day 1, Every 24 weeks from Day 1

]

Secondary outcome(s)

1.

Change from Baseline in PRO2 Scores. PRO2 are patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency.

[

From Baseline in PRO2 Scores from Baseline and up to 144 weeks.

]
2.

Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores

[

From Baseline and up to 144 weeks

]

Target number/sample size

70 subjects from Sri Lanka


Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Croatia, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Province of China, Ukraine, United Kingdom, United States


Anticipated start date

2019-01-28


Anticipated end date

2022-01-12


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404, USA


Regulatory approvals

Approved (Ref: NMRA/SCOCT/P4/CTM/006/2017)



State of Ethics Review Approval


Status

Approved


Date of Approval

2018-05-08


Approval number

P/281/12/2017


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Kelaniya
Institutional Address:PO Box 6, Thalagolla Road, Ragama Sri Lanka
Telephone:+94-11-2961267
Email: erckelaniya@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Prof Arjuna de Silva
Consultant Physician
Research Room, Ward 21, Professorial Unit, Colombo North Teaching Hospital, Ragama 11010, Sri Lanka

+ 94-777572379

arjunapdesilva@hotmail.com

Contact Person for Public Queries

Prof Arjuna de Silva
Consultant Physician
Research Room, Ward 21, Professorial Unit, Colombo North Teaching Hospital, Ragama 11010, Sri Lanka

+ 94-777572379

arjunapdesilva@hotmail.com


Primary study sponsor/organization

Gilead Sciences, Inc

Gilead Clinical Study Information Center 333 Lakeside Drive Foster City, CA 94404, USA
+1-833-445-3230

GileadClinicalTrials@gilead.com

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description

Not available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results