Ulcerative ColitisPhase 1NCT03705117
Open-label V565 Target Engagement Study
A Phase 1 study testing V565 in people with Ulcerative Colitis, run by VHsquared Ltd. at 1 site in United Kingdom.
Trial summary
The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and reduces inflammation after oral dosing to patients with IBD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- V565
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 May 2017to 24 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of UC for 12 months or more
- Distal disease, accessible by flexible sigmoidoscopy
- Mild to moderate UC as defined as Mayo score between 3 - 10 with Mayo endoscopic sub score ≥1
Who cannot join
- A known hypersensitivity to any of the inactive ingredients of the study treatment
- A diagnosis of any IBD except UC
- Isolated proctitis
- Stool culture positive for C. difficile or other enteric infection
- Untreated tuberculosis (TB); positive QuantiFERON-TB Gold Test result (performed by Central Laboratory)
- Evidence of previous or present hepatitis B or C infection
Show all 15Show fewer
- Known severe viral infection within six weeks prior to Visit 1
- Current use of topical mesalazine or anti-infectives for serious infection (or within 1 week)
- Anti-TNFα therapy other than the study drug
- Parenteral or enteral nutrition therapy
- Current use of any biologic agent
- Primary failure or secondary loss of response (LOR) to use of a TNFα inhibitor
- Contraindication to TNFα inhibitor
- Clinically significant abnormal laboratory test result at screening
- Taken an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Exploratory Study in Patient Volunteers With Ulcerative Colitis (UC), to Investigate Lamina Propria Presence and Evidence of Biological Effect of the Oral Domain Antibody V565
The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and reduces inflammation after oral dosing to patients with IBD.
Read the detailed description
Single-site, open-label study in up to 6 patients treated for up to 7 days with sigmoidoscopy and biopsies before and after treatment period to determine biological activity.
- Conditions
- Ulcerative Colitis
- Being tested
- V565
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V565Biological
Capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| V565 | Experimental | V565 orally three times daily for up to 7 days Receives: Biological: V565 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of phosphorylation in mucosal biopsies
Measured: After 7 days oral treatment
Presence of drug in mucosal biopsies
Measured: After 7 days oral treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start23 May 2017
- Primary completion24 Oct 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- VHsquared Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suhail Nurbhai, MBChB, Study director, VHsquared Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705117
- Sponsor's protocol ID
- V56503
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Exploratory Study in Patient Volunteers With Ulcerative Colitis (UC), to Investigate Lamina Propria Presence and Evidence of Biological Effect of the Oral Domain Antibody V565
- ClinicalTrials.gov ID
- NCT03705117
- Acronym / sponsor ID
- V56503
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- VHsquared Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2017 (actual)
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and reduces inflammation after oral dosing to patients with IBD.
Detailed description
Single-site, open-label study in up to 6 patients treated for up to 7 days with sigmoidoscopy and biopsies before and after treatment period to determine biological activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V565 | Experimental | Biological: V565V565 orally three times daily for up to 7 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established diagnosis of UC for 12 months or more
- Distal disease, accessible by flexible sigmoidoscopy
- Mild to moderate UC as defined as Mayo score between 3 - 10 with Mayo endoscopic sub score ≥1
Key exclusion criteria (15 listed)
- A known hypersensitivity to any of the inactive ingredients of the study treatment
- A diagnosis of any IBD except UC
- Isolated proctitis
- Stool culture positive for C. difficile or other enteric infection
- Untreated tuberculosis (TB); positive QuantiFERON-TB Gold Test result (performed by Central Laboratory)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V565Capsules for oral administration | Biological | V565 |
Primary outcome
Reduction of phosphorylation in mucosal biopsies
Time frame: After 7 days oral treatment
Presence of drug in mucosal biopsies
Time frame: After 7 days oral treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suhail Nurbhai, MBChB study director
VHsquared Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V565 in people with Ulcerative Colitis, run by VHsquared Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of phosphorylation in mucosal biopsies (time frame: After 7 days oral treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.