Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients (ADENOIBD)
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|ClinicalTrials.gov Identifier: NCT03773952|
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: PBF-677 Drug: Placebo oral capsule||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized, double blind, placebo controlled, multicenter clinical trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Experimental: Oral 5-ASA + PBF-677 200 mg
Oral Mesalazine (5-ASA) (4g) + PBF-677 (200mg)
oral small molecule, antagonist of Adenosine A3 receptor (AA3R)
Placebo Comparator: Oral 5-ASA + Placebo oral Capsules
Oral Mesalazine (5-ASA) (4g) + Placebo oral capsules
Drug: Placebo oral capsule
- 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
- Effect of PBF-677 on Faecal calprotectin levels [ Time Frame: 28 Days ]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.
- Effect of PBF-677 on Ulcerative Colitis activity [ Time Frame: 28 Days ]
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
- Pharmacokinetic PBF-677 peak concentration in plasma [ Time Frame: Day 1 and Day 14 ]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
- Pharmacokinetic Time to PBF-677 peak concentration in plasma "Tmax" [ Time Frame: Day 1 and Day 14 ]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.
- Pharmacokinetic Area under curve (AUC) of PBF-677 in plasma [ Time Frame: Day 1 and Day 14 ]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
- Pharmacokinetic Ctrough plasma concentration of PBF-677 [ Time Frame: Day 1 and Day 14 ]Trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration])
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): NCT03773952
|Contact: Nahomi Castro Palomino, Ph.D||+34 firstname.lastname@example.org|
|Contact: Tamara Corderoemail@example.com|
|Unidad de Enfermedad Inflamatoria Intestinal / IBD Unit. Servicio de Gastroenterología y Hepatología / Gastroenterology and Hepatology Dpt. Study Medical Coordinator Hospital Universitario Puerta de Hierro||Recruiting|
|Contact: Yago González Lama, MD, PhD|