A Clinical Trial of Antibody GSK1070806 in the Treatment of Patients With Moderate to Severe Crohn's Disease (CDAID)
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|ClinicalTrials.gov Identifier: NCT03681067|
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : April 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Drug: GSK1070806 Drug: Placebo- sodium chloride||Phase 1 Phase 2|
The proposed study will be a randomised, double blind, placebo-controlled trial to investigate the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of single intravenous infusion (one dose on Day 1) of GSK1070806 or placebo, in patients with active, moderate to severe CD. The primary objective of the study is to assess the safety and tolerability of a single dose IV administration of GSK1070806. A secondary objective will be to evaluate the effect of GSK1070806 in change of CDAI over time. Further secondary endpoints will include assessment of endoscopic response in patients at week 12. (Other secondary endpoints are detailed in Section 2.3).
30 patients will be recruited with randomisation of 2:1 active drug to placebo in multiple centres in the UK. After 30 patients have been recruited into the study the sample size will be reassessed and up to an additional 6 patients could be recruited (i.e. up to 36 patients). These additional patients will also be recruited with randomisation of 2:1 active drug to placebo.
An initial screening shall take place to identify patients diagnosed with CD for at least 3 months prior to screening, active disease based on CDAI score of 220-450 points and colonoscopic confirmation of active mucosal inflammation (SES-CD excluding narrowed component ≥6; or in patients with isolated ileal disease ≥4).
Patients who do not have colonoscopically demonstrated mucosal inflammation will be excluded even if they have MRI evidence of Crohn's disease more proximally in the small intestine. For inclusion, CDAI criteria have to be fulfilled within 7 days prior to dosing and colonoscopic SES-CD criteria has to be fulfilled with 28 days prior to dosing.
The induction of clinical activity will be assessed at week 12 by CDAI score, average clinical SF and/or AP scores as well as by colonoscopic assessment of baseline video images and week 12 video images.
The first 5 patients randomised into the trial will be dosed at least 3 days apart. At the interim analysis time point, a safety decision will be taken on the subsequent recruitment and patient spacing out strategy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients With Moderate-to-Severe Crohn's Disease|
|Actual Study Start Date :||February 20, 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Humanised antibody GSK1070806
GSK1070806 100mg/ml injectable solution will be delivered via intravenous infusion as a single infusion
Placebo Comparator: Placebo - sodium chloride
Drug: Placebo- sodium chloride
Placebo injectable solution will be delivered via intravenous infusion as a single infusion
Other Name: Placebo
- Safety and tolerability parameters include: adverse events and serious adverse events [ Time Frame: 24 weeks ]NCI-CTCAE criterion Version 4
- Safety and tolerability parameters include: clinical laboratory tests (Haematology) [ Time Frame: 24 weeks ]Haematology panel : haemoglobin (g/L), Platelets (10*9/L), White Blood Cells (10*9/L), International normalized ratio, Neutrophils (10*9/L)
- Safety and tolerability parameters include: clinical laboratory tests (Biochemistry) [ Time Frame: 24 weeks ]Biochemistry Panel : Creatinine (umol/L), Sodium (mmol/L), Potassium (mmol/l), Bilirubin (umol/L), Alanine Transferase (u/L) Aspartate Transaminase (U/L), Albumin (g/L), eGFR ml/min/1.7, C-Reactive Protein (CRP)
- Safety and tolerability parameters include: Cardiology [ Time Frame: 24 weeks ]Electrocardiogram review - for any abnormalities i.e. QT interval etc.
- Safety and tolerability parameters include: frequency, type and severity of infections [ Time Frame: 24 weeks ]NCI-CTCAE criterion Version 4 - grading system used
- Safety and tolerability parameters include: Heart Rate (vital signs) [ Time Frame: 24 weeks ]Heart rate
- Safety and tolerability parameters include: Blood Pressure (vital signs) [ Time Frame: 24 weeks ]Blood pressure
- Safety and tolerability parameters include: Body Temperature (vital signs) [ Time Frame: 24 weeks ]Oral body temperature
- Safety and tolerability parameters include: Respiratory Rate (vital signs) [ Time Frame: 24 weeks ]Respiratory rate
- CDAI score over time. Patients [ Time Frame: 28 weeks ]Crohns disease activity index score (Pre-treatment, Post treatment). Scale ranges from <150(remission) to >450(severe Crohn's disease).
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): NCT03681067
|Contact: Marietta Iacucci, MD, PhD||+44(0)121 firstname.lastname@example.org|
|Contact: Manpreet K Wilkhu, BSc||+44(0)121 email@example.com|
|Principal Investigator:||Marietta Iacucci, MD,PhD||University of Birmingham|