Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 24 January 2022
• Main ID: NCT03773952
• Date of registration: 30/11/2018
• Prospective Registration: No
• Primary sponsor: Palobiofarma SL
• Public title: Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients ADENOIBD
• 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: July 1, 2018
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03773952
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Spain

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

- 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.

Exclusion Criteria:

- 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.

- 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: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Placebo oral capsule

Drug: PBF-677

Primary Outcome(s)

Number of subjects with treatment-related adverse events as assessed by CTCAE v4.03" [Time Frame: 28 Days]

Secondary Outcome(s)

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]

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]

Effect of PBF-677 on Faecal calprotectin levels [Time Frame: 28 Days]

Effect of PBF-677 on Ulcerative Colitis activity [Time Frame: 28 Days]

Secondary ID(s)

PBF-677-3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Qualitecfarma