Ulcerative ColitisPhase 2ADENOIBDNCT03773952
Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients
A Phase 2 study testing PBF-677 in people with Ulcerative Colitis, run by Palobiofarma SL at 1 site in Spain.
Trial summary
This is a Phase IIa (proof of concept), randomized, double blind, placebo-controlled, multicentre clinical trial to evaluate the safety and efficacy of daily PBF-677 oral treatment during 28 days in Ulcerative colitis (UC) patients who are not receiving immunosuppressants and present mild-to-moderate activity of the… 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?
- PBF-677
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2018to 27 May 2021
- Phase
- Phase 2
- 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
- Able and willing to provide written informed consent
- Male or Female, 18 to 75 years of age, inclusive
- Patient with previous diagnosis of ulcerative colitis: ulcerative proctitis, left-side ulcerative colitis or extensive/pancolitis (E1, E2 and E3 of Montreal Classification, respectively) established at least 3 months prior to screening and determined by ordinary clinical, endoscopic, and histological procedures.
- Patient who has stable oral 5-ASA dose < 4 gr/day treatment, within 1 month prior to screening.
- Mild-to-moderate activity of the disease determined clinically during the screening period by Partial Mayo Clinical Score of ≤ 6, with rectal bleeding score ≤ 2 and/or a bowel frequency score ≤ 2.
- Patient in flare of the disease.
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- Patient with faecal calprotectin levels > 50 mg/Kg
- Availability for the entire study period, absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; willingness to adhere to the protocol requirements, ability to cooperate adequately, to understand and follow the instructions of the physician or designee.
- Women who are not postmenopausal (at least 12 months) or surgically sterile must have a negative pregnancy test at screening and at the end of study and either abstain from sexual intercourse or use a highly effective method of birth control for the duration of the study and after 12 weeks after the last dose of study drug.
- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm for the duration of the study and after 12 weeks from the last dose of study drug.
Who cannot join
- Patient who has treatment, within 3 months prior to screening, with immunomodulators including corticosteroids, azathioprine, mercaptopurine, biologics, tacrolimus, cyclosporine, for disease control.
- Patient who has stable oral 5-ASA dose ≥ 4 gr/day treatment, within 1 month prior to screening.
- Patient with C-reactive Protein levels (CRP) ≥ 10 mg/L
- Patient who has anti-diarrheal treatment, within 3 months prior to screening.
- Use of prescription medications started or with a dose adjustment within 4 weeks prior to study enrolment, or OTC medications or supplements started or with a dose adjustment within 2 weeks prior study enrolment.
- Use of products, food supplements or medical devices, whose composition includes probiotics in the 3 months prior to the selection.
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- Patient who has fulminant or severe colitis, toxic megacolon, primary sclerosing cholangitis, Crohn's disease, history of colitis associated colonic dysplasia or active peptic ulcer disease.
- Patient who has prior extensive colonic resection, subtotal or total colectomy or planned surgery for UC
- Patient who has past or present fistula or abdominal abscess
- Patient who has clinically significant diseases and/or infections captured in the medical history or evidence of clinically significant findings on physical examination and/or clinically significant ordinary laboratory evaluations (haematology, biochemistry, and urinalysis) or ECG.
- Patient who has evidence of significant liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- Patient who is currently participating in another clinical trial of an investigational drug or medical device within 90 days prior to screening.
- Patient who is pregnant or lactating
- Inability to comply with study protocol, in opinion of the investigator
- History of alcohol, drug or chemical abuse within 6 months prior to screening
- History of cancer except local basal or squamous cell carcinoma of the skin that has been excised and is considered cured.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad de Enfermedad Inflamatoria Intestinal / IBD Unit. Servicio de Gastroenterología y Hepatología / Gastroenterology and Hepatology Dpt. Study Medical Coordinator Hospital Universitario Puerta de Hierro
Madrid
About this study
Official title: A Phase IIa (Proof of Concept), Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Oral Treatment With PBF-677 in Patients With Mild to Moderate Ulcerative Colitis
This is a Phase IIa (proof of concept), randomized, double blind, placebo-controlled, multicentre clinical trial to evaluate the safety and efficacy of daily PBF-677 oral treatment during 28 days in Ulcerative colitis (UC) patients who are not receiving immunosuppressants and present mild-to-moderate activity of the disease. Enrolled patients would receive standard high doses of 5-ASA (4g), according to current clinical guidelines, and are randomized to receive also PBF-677 or placebo.
Read the detailed description
This Proof-of-concept clinical trial is carefully designed to establish the safety profile of PBF-677 over 28 days in mild to moderate ulcerative colitis population and explore the relationship between the 200 mg PBF-677 dose and induction of remission, according to clinical parameters (Partial Mayo Score) and a faecal surrogate biomarker of mucosal inflammation (Calprotectin). The trial also will explore the PBF-677 pharmacokinetics (PK) profile during 28 days of administration.
This small-scale study has been designed to detect a signal that PBF-677 is safe and active on decreasing levels of faecal calprotectin, as well as preliminary evidence of ameliorate the Partial Mayo Clinical Score in colitis patients who are in flare of the disease.
The Population Under Study will be: Around 30 subjects. Adults (18-75 years old) non-immunosuppressed patients with mild to moderate active ulcerative colitis disease.
- Conditions
- Ulcerative Colitis
- Being tested
- PBF-677, Placebo oral capsule
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBF-677Drug
oral small molecule, antagonist of Adenosine A3 receptor (AA3R)
Placebo oral capsuleDrug
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Oral 5-ASA + PBF-677 200 mg | Experimental | Oral Mesalazine (5-ASA) (4g) + PBF-677 (200mg) Receives: Drug: PBF-677 |
| Oral 5-ASA + Placebo oral Capsules | Placebo comparator | Oral Mesalazine (5-ASA) (4g) + Placebo oral capsules Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with treatment-related adverse events as assessed by CTCAE v4.03"
Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. If
Measured: 28 Days
Secondary outcomes (6)
Effect of PBF-677 on Faecal calprotectin levels
Calprotectin levels in stools is a validated biomarker of the severity of the disease. A decrease in the calprotectin levels under 50 mg/Kg is associated with the remission of the disease flare.
Measured: 28 Days
Effect of PBF-677 on Ulcerative Colitis activity
The assessment Will be based on the Partial Mayo Scoring Index that sum and score the following ítems:
- Stool Frequency (based on the past 3 days)
- Rectal Bleeding (based on the past 3 days)
- Physician's Global Assessment
The scoring range is as follow:
Remission = 0-1 Mild Disease = 2-4 Moderate Disease = 5-6 Severe Disease =7-9
Measured: 28 Days
Pharmacokinetic PBF-677 peak concentration in plasma
The parameter will be calculated from plasma samples collected at days 1 and 14 after drug administration. It will consist in the maximum plasma concentration (ng/mL) of PBF-677 observed after administration
Measured: Day 1 and Day 14
Pharmacokinetic Time to PBF-677 peak concentration in plasma "Tmax"
The parameter will be calculated from plasma samples collected at days 1 and 14 after drug administration.It will consist in the time (in minutes) to reach the maximum "PBF-677" concentration in plasma samples of patients after oral administration of PBF-677.
Measured: Day 1 and Day 14
Pharmacokinetic Area under curve (AUC) of PBF-677 in plasma
The parameter will be calculated from plasma samples collected at days 1 and 14 after drug administration. It will consist in the area under the concentration-time curve from zero up to ∞ with extrapolation of the terminal phase. "AUC(0-inf)" will be given in Amount·time/ volume units
Measured: Day 1 and Day 14
Pharmacokinetic Ctrough plasma concentration of PBF-677
Trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration])
Measured: Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start1 Jul 2018
- Primary completion27 May 2021
- Study completion27 May 2021
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double blind, placebo controlled, multicenter clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palobiofarma SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qualitecfarma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773952
- Sponsor's protocol ID
- PBF-677-3
- Acronym
- ADENOIBD
- Status last verified
- Jan 2022
- First submitted
- 30 Nov 2018
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa (Proof of Concept), Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Oral Treatment With PBF-677 in Patients With Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03773952
- Acronym / sponsor ID
- ADENOIBD / PBF-677-3
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Palobiofarma SLIndustry (pharma, biotech, devices)
- Collaborators
- Qualitecfarma
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 12 Dec 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.
This is a Phase IIa (proof of concept), randomized, double blind, placebo-controlled, multicentre clinical trial to evaluate the safety and efficacy of daily PBF-677 oral treatment during 28 days in Ulcerative colitis (UC) patients who are not receiving immunosuppressants and present mild-to-moderate activity of the disease. Enrolled patients would receive standard high doses of 5-ASA (4g), according to current clinical guidelines, and are randomized to receive also PBF-677 or placebo.
Detailed description
This Proof-of-concept clinical trial is carefully designed to establish the safety profile of PBF-677 over 28 days in mild to moderate ulcerative colitis population and explore the relationship between the 200 mg PBF-677 dose and induction of remission, according to clinical parameters (Partial Mayo Score) and a faecal surrogate biomarker of mucosal inflammation (Calprotectin). The trial also will explore the PBF-677 pharmacokinetics (PK) profile during 28 days of administration.
This small-scale study has been designed to detect a signal that PBF-677 is safe and active on decreasing levels of faecal calprotectin, as well as preliminary evidence of ameliorate the Partial Mayo Clinical Score in colitis patients who are in flare of the disease.
The Population Under Study will be: Around 30 subjects. Adults (18-75 years old) non-immunosuppressed patients with mild to moderate active ulcerative colitis disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double blind, placebo controlled, multicenter clinical trial
| Arm | Type | Receives |
|---|---|---|
| Oral 5-ASA + PBF-677 200 mg | Experimental | Drug: PBF-677Oral Mesalazine (5-ASA) (4g) + PBF-677 (200mg) |
| Oral 5-ASA + Placebo oral Capsules | Placebo comparator | Drug: Placebo oral capsuleOral Mesalazine (5-ASA) (4g) + Placebo oral capsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able and willing to provide written informed consent
- Male or Female, 18 to 75 years of age, inclusive
- Patient with previous diagnosis of ulcerative colitis: ulcerative proctitis, left-side ulcerative colitis or extensive/pancolitis (E1, E2 and E3 of Montreal Classification, respectively) established at least 3 months prior to screening and determined by ordinary clinical, endoscopic, and histological procedures.
- Patient who has stable oral 5-ASA dose < 4 gr/day treatment, within 1 month prior to screening.
- Mild-to-moderate activity of the disease determined clinically during the screening period by Partial Mayo Clinical Score of ≤ 6, with rectal bleeding score ≤ 2 and/or a bowel frequency score ≤ 2.
Key exclusion criteria (16 listed)
- Patient who has treatment, within 3 months prior to screening, with immunomodulators including corticosteroids, azathioprine, mercaptopurine, biologics, tacrolimus, cyclosporine, for disease control.
- Patient who has stable oral 5-ASA dose ≥ 4 gr/day treatment, within 1 month prior to screening.
- Patient with C-reactive Protein levels (CRP) ≥ 10 mg/L
- Patient who has anti-diarrheal treatment, within 3 months prior to screening.
- Use of prescription medications started or with a dose adjustment within 4 weeks prior to study enrolment, or OTC medications or supplements started or with a dose adjustment within 2 weeks prior study enrolment.
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 |
|---|---|---|
| PBF-677oral small molecule, antagonist of Adenosine A3 receptor (AA3R) | Drug | Oral 5-ASA + PBF-677 200 mg |
| Placebo oral capsuleOral capsules | Drug | Oral 5-ASA + Placebo oral Capsules |
Primary outcome
Number of subjects with treatment-related adverse events as assessed by CTCAE v4.03"
Time frame: 28 Days
Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. If
6 secondary outcomes
Effect of PBF-677 on Faecal calprotectin levels
Time frame: 28 Days
Effect of PBF-677 on Ulcerative Colitis activity
Time frame: 28 Days
Pharmacokinetic PBF-677 peak concentration in plasma
Time frame: Day 1 and Day 14
Pharmacokinetic Time to PBF-677 peak concentration in plasma "Tmax"
Time frame: Day 1 and Day 14
Pharmacokinetic Area under curve (AUC) of PBF-677 in plasma
Time frame: Day 1 and Day 14
Pharmacokinetic Ctrough plasma concentration of PBF-677
Time frame: Day 1 and Day 14
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 13 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PBF-677 in people with Ulcerative Colitis, run by Palobiofarma SL at 1 site in Spain.
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 10 inclusion and 16 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 13 Jan 2022. 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 Spain. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of subjects with treatment-related adverse events as assessed by CTCAE v4.03" (time frame: 28 Days). 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 13 Jan 2022.