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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03681067
Date of registration: 20/08/2018
Prospective Registration: Yes
Primary sponsor: University of Birmingham
Public title: A Clinical Trial of Antibody GSK1070806 in the Treatment of Patients With Moderate to Severe Crohn's Disease CDAID
Scientific 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
Date of first enrolment: February 20, 2019
Target sample size: 30
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03681067
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 1/Phase 2
Countries of recruitment
United Kingdom
Contacts
Name:     Marietta Iacucci
Address: 
Telephone: +44 (0)121 3718119
Email: m.iacucci@bham.ac.uk
Affiliation: 
Name:     Marietta Iacucci, MD, PhD
Address: 
Telephone: +44(0)121 3718119
Email: m.iacucci@bham.ac.uk
Affiliation: 
Name:     Marietta Iacucci, MD,PhD
Address: 
Telephone:
Email:
Affiliation:  University of Birmingham
Key inclusion & exclusion criteria

Inclusion Criteria:

A patient will be eligible for inclusion in this study only if all of the following
criteria apply:

1. Written informed consent prior to any of the screening procedures including
discontinuation of prohibited medications. (see Section 7.11 for additional
information)

2. Patients that have been diagnosed with moderate to severe Crohn's disease for at least
3 months prior to Screening Visit 1 defined by CDAI score between 220-450

3. Patients are required to have endoscopic evidence of active Crohn's disease at
Baseline (screening visit 1) defined by endoscopic appearance: SES-CD excluding the
narrowed component of = 6 (or =4 for patients with isolated ileal disease).

4. AST and ALT = 2xULN; alkaline phosphatase and bilirubin = 1.5xULN (isolated bilirubin
>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)

5. Male or female participants aged =16 years (up to 80 years)

Male participants:

6. A male participant must agree to use contraception as detailed in Appendix 5 of this
protocol for at least 180 days post-dose of study medication and refrain from donating
sperm during this period.

Female participants:

7. A female participant is eligible to participate if she is not pregnant or breastfeeding
and not a woman of childbearing potential (WOCBP) defined as at least one of the following
conditions: i. Premenopausal female with documented hysterectomy ii Premenopausal female
with documented bilateral salpingectomy or oophorectomy iii. Postmenopausal female defined
as no menses for 12 months without an alternative medical cause. A high follicle
stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a
postmenopausal state in women not using hormonal contraception or hormonal replacement
therapy (HRT). However, in the absence of 12 months of amenorrhea, a single FSH measurement
is insufficient.

iv. Females on HRT and whose menopausal status is in doubt will be required to use one of
the non-hormonal highly effective contraception methods if they wish to continue their HRT
during the trial. Otherwise, they must discontinue HRT to allow confirmation of
postmenopausal status before trial enrolment.

v. A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 for at least 180
days post-dose of trial medication. If a hormonal method of birth control is selected from
the list in Appendix 1 then participants must have been using these methods at least 28
days prior to GSK1070806 administration, or be abstinent, or utilise a condom as a method
of contraception until the selected hormonal method has been in place for the 28 day
period.

Exclusion Criteria:

A participant will not be eligible for inclusion in this trial if any of the following
criteria apply:

1. Diagnosis of ulcerative or indeterminate colitis

Crohn's Disease complications:

2. Evidence of an infected abscess by MRI or other examinations

3. Bowel surgery other than appendectomy within 12 weeks prior to screen and/or has
planned surgery or deemed likely to need surgery for CD during the trial period

4. Participants with ileostomies, colostomies or rectal pouches

5. Participants with a bowel stricture that is fixed

6. Participants with evidence of short bowel syndrome

7. Participants requiring enteral or parenteral feeding

8. Deep penetrating ulcers at endoscopy thought to be at risk for perforation

Viral and bacterial infections:

9. Presence of Hepatitis B surface antigen (HBsAg), (confirmed by Hepatitis B surface
antigen test - within 12 months of randomisation) core antigen (HBcAg) or surface
antibody (HBsAb), positive Hepatitis C (qualitative enzyme immunoassay) test result

10. Known varicella, herpes zoster, or other severe viral infection within 6 weeks of
randomisation

11. The participant has a history of tuberculosis (TB) disease or latent TB infection, in
the absence of documented adequate therapy for same.

12. Positive screening test for TB (including T-SPOT.TB TB test), unless respiratory
review confirms false positive test results

13. History of uncontrolled bacterial or fungal infection requiring intravenous
antibiotics

14. Positive immunoassay for Clostridium difficile toxin and other enteric pathogens

Other exclusion criteria:

15. Cardiology assessment/co-morbidity defined as:

i. QTc >450 msec (480msec for those with Bundle Branch Block) and/or ii. either QTcb
or QTcf, machine or manual overread, males or females. The QT correction formula used
to determine exclusion and discontinuation should be the same throughout the trial
and/or iii. based on single QTc value (average of triplicate readings) of ECG obtained
over a brief recording period

16. The participant has congenital or acquired immunodeficiency, or a history of chronic
or recurrent opportunistic infections

17. The participant has current evidence of, or has been treated for a malignancy within
the past five years (other than localised basal cell, squamous cell skin cancer,
cervical dysplasia, or cancer in situ that has been resected)

18. Use of any investigational drug within 30 days prior to screening, 5 half-lives or
twice the duration of the biological effect of the investigational product (whichever
is longer)

19. Participant has received live, attenuated or recombinant vaccine(s) within 2 months of
randomisation or will require vaccination within 3 months of trial drug infusion

20. Any patients that are receiving medication(s) detailed in Section 7.11.2 of the trial
protocol, will not be eligible for randomisation into the trial



Age minimum: 16 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: GSK1070806
Drug: Placebo- sodium chloride
Primary Outcome(s)
Safety and tolerability parameters include: adverse events and serious adverse events [Time Frame: 24 weeks]
Safety and tolerability parameters include: Blood Pressure (vital signs) [Time Frame: 24 weeks]
Safety and tolerability parameters include: Body Temperature (vital signs) [Time Frame: 24 weeks]
Safety and tolerability parameters include: Cardiology [Time Frame: 24 weeks]
Safety and tolerability parameters include: clinical laboratory tests (Biochemistry) [Time Frame: 24 weeks]
Safety and tolerability parameters include: clinical laboratory tests (Haematology) [Time Frame: 24 weeks]
Safety and tolerability parameters include: frequency, type and severity of infections [Time Frame: 24 weeks]
Safety and tolerability parameters include: Heart Rate (vital signs) [Time Frame: 24 weeks]
Safety and tolerability parameters include: Respiratory Rate (vital signs) [Time Frame: 24 weeks]
Secondary Outcome(s)
CDAI score over time. Patients [Time Frame: 28 weeks]
Secondary ID(s)
2018-002001-65
RG_17-258
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
GlaxoSmithKline
University Hospital Birmingham
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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