| Trial ID: | L0452 |
| Source ID: | EUCTR2019-001897-27-FR
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| Associated Drug: |
BFKB8488A
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| Title: |
A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TOEVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF BFKB8488A COMPAREDWITH PLACEBO IN PATIENTS WITH NON-ALCOHOLIC STEATOHEPATITIS.
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| Acronym: |
--
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| Status: |
Authorised
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non-alcoholic steatohepatitis (NASH) <br>MedDRA version: 22.0
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therapeutic area: Diseases [C] - Nutritional and Metabolic Dis
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| Interventions: |
<br>Product Name: BFKB8488A<br>Product Code: RO7040551<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: BFKB8488A<br>Current Sponsor code: BFKB8488A - RO7040551<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration ty
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| Outcome Measures: |
Main Objective: ?€? To evaluate the efficacy of BFKB8488A compared with placebo on the basis of resolution of NASH without worsening of fibrosis;Secondary Objective: ?€? To evaluate the efficacy of BFKB8488A compared with placebo on the basis of hepatic fat fraction assessed by magnetic resonance imaging- derived proton density fat fraction (MRI-PDFF), proportion of patients with improvement in liver histology in non-alcoholic fatty liver disease (NAFLD) activity score [NAS], in liver fibrosis greater than or equal to one stage and no worsening of steatohepatitis<br>?€? To evaluate the safety of BFKB8488A compared with placebo on the basis of incidence and severity of adverse events, changes in vital signs, clinical laboratory test results<br>?€? To evaluate the BFKB8488A pharmacokinetic (PK) profile on the basis of the serum concentration of BFKB8488A<br>?€? To evaluate the immune response to BFKB8488A on the basis of incidence and titer of anti-drug antibodies (ADAs)<br>;Primary end point(s): 1. Proportion of patients with resolution of NASH on overall histopathological reading, without worsening of fibrosis at Week 52;Timepoint(s) of evaluation of this end point: 1. At Week 52Secondary end point(s): 1.Change from baseline in hepatic fat fraction as assessed by MRI-PDFF at Week 52
<br>2.Proportion of patients improvement in fibrosis of at least 1 stage from baseline with no worsening of NASH at Week 52
<br>3.Proportion of patients improvement in NAS score by at least 2 points from baseline at Week 52
<br>4.Incidence and severity of adverse events, with severity determined according to the
<br>National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale
<br>5.Change from baseline in targeted vital signs
<br>6.Change from baseline in targeted clinical laboratory test results
<br>7.Maximum serum concentration observed (Cmax) of BFKB8488A
<br>8.Minimum serum concentration observed (Cmin) of BFKB8488A
<br>9.Incidence and titer of ADAs during the study relative to the prevalence of ADAs at baseline;Timepoint(s) of evaluation of this end point: 1. At Week 52
<br>2-3. At Week 52
<br>4. Up to Week 58 (or up to 6 weeks after the final dose of study drug)
<br>5-6. Baseline to Week 58
<br>7-8. Week 0, Week 4, Week 8, Week 12, Week 16, Week 28, Week 29, Week 40, Week 52, Week 58 and unscheduled visit
<br>9. Week 0, Week 4, Week 8, Week 12, Week 16, Week 28, Week 40, Week 52, Week 58 and unscheduled visit
<br>
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| Sponsor/Collaborators: |
Genentech Inc
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
260
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 6
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| Start Date: |
07/10/2019
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
18 May 2020
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| Locations: |
United States;France;Belgium
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001897-27
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