Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.

Phase 2

Completed

• Conditions: inflammatory bowel disease (IBD); Ulcerative Colitis ( UC); 10017969

• Registration Number: NL-OMON40072
• Lead Sponsor: Enceladus Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

1.Male or non pregnant, non-lactating female >= 18 to 75 years of age.
2.Documented history of UC (at least 6 months) as assessed by endoscopy and confirmed by histological measurements with a minimal disease extent of 15 cm from the anal verge and a minimal period of moderately active disease of 14 days.
3.Negative stool culture for enteric pathogens, including Clostridium difficile, ova and parasites.
4.Mayo score >= 5 with endoscopic sub-score of >= 2 and rectal bleeding sub-score >=1.
5.Medication: 6-MP/azathioprine, MTX receiving for at least 12 weeks and stable dose for > 4 weeks or discontinued for > 4 weeks; rectal medications stopped for > 4 weeks, 5-ASA stable or stopped for > 2 weeks. If receiving cyclosporine or biologicals (e.g. TNFa blocker), these medications should be continued at the same dose for at least two cycles after Day 1. A cycle commonly takes 8 weeks, but may be shorter in the individual subject, when loss of response has been encountered previously and the dosing interval has been adjusted.
6.In good physical and mental health (other than the disease under study) as determined by medical history and physical examination.
7.The results of the following laboratory tests performed at the local laboratory at screening must be as below:
a.Hemoglobin >= 8.5 g/dL (International System of Units [SI]: >= 85 g/L)
b.White blood cells (WBC) >= 3.0 x 10E3 cells/mm3 (SI: >= 3.0 x109 cells/L)
c.Neutrophils >= 1.5 x 10E3 cells/mm3 (SI: >= 1.5 x109 cells/L)
d.Platelets >= 100 x 10E3 cells/mm3 (SI: >= 100 x109 cells/L)
e.Serum ALT <= 1.5 x upper limit of normal (ULN)
f.Total bilirubin level >= 1.25 x ULN
g.Creatinine clearance >80 mL/min using the Cockcroft formula
8.Female subjects must have a negative blood pregnancy test, unless they are surgically sterile, had a hysterectomy or have been post-menopausal for at least 1 year (at least 12 consecutive months without menses).
9.Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 12 weeks after the last dose of study drug. Medically acceptable forms of birth control include oral contraceptives, injectable or implantable methods, intrauterine devices, tubal ligation (if performed more than 1 year before screening), or double-barrier contraception. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue for at least 12 weeks after the last dose of study drug.
10.Able and willing to give voluntary written informed consent and agree to schedule of assessments.

Exclusion Criteria

1.Treatment with local or oral corticosteroids within 4 weeks of screening or with intra articular or intramuscular corticosteroids within 8 weeks before screening. If non-systemic steroids are being used for other chronic inflammatory conditions, subjects may be included at the discretion of the investigator after discussion with the medical monitor.
2. Severe colitis, defined as a bloody stool frequency of more than six per day with any one of tachycardia (pulse > 90 beats/min), temperature (> 37.8 degrees C), anaemia (haemoglobin < 10.5 g/dL or 6,5 mmol/L) or raised erythrocyte sedimentation rate (> 30 mm/h),
3.Intolerance of or unresponsiveness to corticosteroids, especially a history of steroid psychosis.
4.A history of significant psychological, neurologic, renal, gastrointestinal (other than ulcerative colitis), or metabolic disease. (diabetes mellitus)
5.A history of clinically severe or unstable medical condition involving cardiac, pulmonary, liver or endocrine disorders.
6.Any concurrent illness, disability or clinical abnormality (including laboratory tests) that may affect the interpretation of clinical safety or efficacy data or prevent the subject from safely completing the assessments required by the protocol as determined by the investigator.
7.The subject has a Stoma, proctocolectomy or total colectomy or imminent need for surgery.
8.Concurrent bowel and/or intestine malignancy or a history of cancer (other than basal cell carcinoma or cervical carcinoma successfully treated more than 5 years prior to screening be allowed);
9.Subjects with other bleeding, infectious, ischemic, or immunological diseases with or without gastrointestinal involvement.
10.Be currently pregnant or breastfeeding or not willing to maintain birth control methods for at least 12 weeks after last study medication administration.
11.Medical, psychiatric, cognitive, or other conditions that, according to investigator*s medical judgment, compromise the patient's ability to understand the patient information, to give informed consent, to comply with requirements of the study the study protocol (that is likely to affect the patient*s return for visits on schedule), or ability to complete the study.
12.Participation in another experimental therapy study within 90 days prior to screening for this study or current enrollment in any other study with investigational drugs or device.
13.Positive serology for human immunodeficiency virus (HIV) 1 or 2 or hepatitis B or C, or any history of HIV or hepatitis from any cause with the exception of hepatitis A.

Study & Design

• Study Type: Interventional
• Study Design: Not specified