A clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis.

• Register: EUCTR
• Last refreshed on: 18 June 2018
• Main ID: EUCTR2017-003228-54-ES
• Date of registration: 09/04/2018
• Prospective Registration: Yes
• Primary sponsor: PaloBiofarma S.L.
• Public title: A clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis.
• Scientific 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.
• Date of first enrolment: 28/05/2018
• Target sample size: 30
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003228-54
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Spain

Contacts

• Name: Óscar Mesa del Castillo
• Affiliation: QualitecFarma s.l.

• Name: Óscar Mesa del Castillo
• Affiliation: QualitecFarma s.l.

Key inclusion & exclusion criteria

Inclusion criteria:
Patients must meet the following criteria for study entry:
- 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 (extensive or pancolitis, E3 of Montreal Classification) 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 = 3 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.
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
Patients must not meet any of the following criteria for study entry:
- Patient who has treatment, within 3 months prior to screening, with immunomodulators including corticosteroids, azatioprine, mercaptopurine, biologics, tacrolimus, cyclosporine, for disease control.
- Patient who has stable oral 5-ASA dose > 3 gr/day treatment, within 1 month prior to screening.
- Patient with C-reactive Protein levels (CRP) = 10 mg/L
- Patient who has topic 5-ASA treatment, within 1 month prior to screening.
- 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.
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Inflammatory Bowel disease, mild to moderate Ulcerative Colitis

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Code: PBF-677
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PBF-677
Current Sponsor code: PBF-677
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: The trial also will explore pharmacokinetics (PK) profile and preliminary therapeutic efficacy associated with PBF-677 through biomarker analysis and clinical assessments

Main Objective: The trial primary goal will be to evaluate the safety and tolerability of PBF-677 in patients with mild to moderate active ulcerative colitis disease over 28 days.

Primary end point(s): Safety Assessments
- Safety of PBF-677 administered for 28 days by assessing the number, severity, and type of AE, including changes in vital signs, physical examination, safety laboratory values, and ECGs.

Efficacy Assessments:
- Effect of PBF-677 on Faecal calprotectin levels [ Time Frame: Day 1, Day 7, Day 14, Day 21 and Day 28]
- Change in Partial Mayo Clinical Score induced by PBF-677 treatment compared to placebo [ Time Frame: Day 1, Day 14 and Day 28]

Timepoint(s) of evaluation of this end point: Safety Assessments
- Safety of PBF-677 administered for 28 days by assessing the number, severity, and type of AE, including changes in vital signs, physical examination, safety laboratory values, and ECGs.

Efficacy Assessments
- Effect of PBF-677 on Faecal calprotectin levels [ Time Frame: Day 1, Day 7, Day 14, Day 21 and Day 28]
- Change in Partial Mayo Clinical Score induced by PBF-677 treatment compared to placebo [ Time Frame: Day 1, Day 14 and Day 28]

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Pharmacokinetics
- Pharmacokinetics (PK): Cmax in plasma (Time Frame: Day 1 and Day 14; Tmax in plasma [ Time Frame: Day 1 and Day 14]; Area under curve (AUC) in plasma [ Time Frame: Day 1 and Day 14]; Ctrough in plasma [ Time Frame: Day 1 and Day 14];

Secondary end point(s): Pharmacokinetics
- Pharmacokinetics (PK): Cmax in plasma (Time Frame: Day 1 and Day 14; Tmax in plasma [ Time Frame: Day 1 and Day 14]; Area under curve (AUC) in plasma [ Time Frame: Day 1 and Day 14]; Ctrough in plasma [ Time Frame: Day 1 and Day 14];

Secondary ID(s)

PBF-677-3

Source(s) of Monetary Support

PaloBiofarma S.L.