A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis

• Register: EUCTR
• Last refreshed on: 16 August 2016
• Main ID: EUCTR2012-004768-23-DE
• Date of registration: 06/02/2013
• Prospective Registration: Yes
• Primary sponsor: STELIC INSTITUTE & CO.
• Public title: A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis
• Scientific title: A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis
• Date of first enrolment: 12/06/2013
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004768-23
• 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: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: Hiroyuki Yoneyama, MD, PhD
• Affiliation: STELIC INSTITUTE & CO.

• Name: Hiroyuki Yoneyama, MD, PhD
• Affiliation: STELIC INSTITUTE & CO.

Key inclusion & exclusion criteria

Inclusion criteria:
Subject eligibility is determined according to the following criteria:
1) Male/female
2) The subject is a patient with Ulcerative colitis with active lesion(s).
3) The subject has been treated for more than 2 months before the screening
tests by conventional drug(s) generally used to treat Ulcerative colitis [e.g.,
5-aminosalicylic acid agent, steroid, immunoregulating agent, biological
agent (e.g. anti-TNF-a antibody or Vedolizumab need a wash out period of 4
weeks)]. In the opinion of his primary doctor, the subject has experienced an
insufficient response or resistance to one of the current conventional
treatment options. The subject’s insufficient response or resistance to the
current treatment is also confirmed by the principal investigator of this
study, based on the screening tests including endoscopic examination,
clinical examination and laboratory tests.
The subject’s experiencing an “insufficient response or resistance” can be
assessed at the primary doctor’s and principal investigator’s discretion;
however, use of one prescribed medication and insufficient therapeutic
effect by the medication(s) at present should be documented in the subject’s
medical record.
4) The subject has little difficulty with the introduction of an endoscope, e.g., he has little stenosis or, if any, the diameter of the narrowed lesion is 14 mm or more.
5) Endoscopic Mayo score at Screening has to be 1 or above 1.
6) The subject’s age is 18 or older and under 65 at the time of informed consent.
7) The subject signs and dates a written informed consent to participate in the study.
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 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
Any subject who meets any of the following criteria will not qualify for entry into the study:
1) The subject has or has a history of serious cardiac, hematological or pulmonary disease, and is unsuitable, in the investigator’s opinion, to participate in the study.
2) The subject has a history of complete colon resection surgery for Ulcerative colitis.
3) The subject has a complication of Ulcerative colitis such as severe bleeding or intestinal adhesions to other organs, and is unsuitable, in the investigator’s opinion, to participate in the study.
4) The subject has an anal stenosis that affects defecation frequency, or perianal abscess with fever. However, the subject is eligible if his bowel movement has been improved by Seton method.
5) The subject has an obviously reduced general condition.
6) The subject in whom large parts of the colon are affected (pancolitis).
7) The subjects who are expected to evince an indication for colectomy during the study participation.
8) The subject is currently receiving total parenteral nutrition.
9) The subject has a hepatic impairment or renal disorder, and is unsuitable, in the investigator’s opinion, to participate in the study.
10) The subject has or has a history of malignant tumor within the past 5 years.
11) The subject has or has a history of abdominal phthisis.
12) The subject has a complication of serious infection that requires hospitalization.
13) The subject should be excluded if he is currently treated with biological agents (e.g. anti-TNF-alpha antibody or Vedolizumab).
14) The subject should be excluded if he is treated with concomitant medication [e.g., 5-aminosalicylic acid agent, steroid, immunoregulating agent] by local administration.
15) The subject has a history of clinically serious allergic symptom. “Serious” means an allergic symptom causing generalized hives, anaphylaxis or shock requiring hospitalization, when exposed to a specific antigen or drug.
16) The subject has a history of HBV, HCV and/or HIV infection.
17) The person has alcohol or drug dependency.
18) The subject’s conventional treatment for Ulcerative colitis has been changed in its ‘quality’ (medication class) of therapy regimen or added with a new treatment: No introduction of thiopurines the previous 3 months, no Change of dosing 5-ASA or corticosteroids within 14 days prior to the study drug administration.
19) The subject is currently participating or plans to participate in another clinical study during the course of this study.
20) The subject received administration of any other investigational product within 6 months prior to the informed consent for this study.
21) The subject has any psychiatric or neurological disorder, and is unsuitable, in the investigator’s opinion, to participate in the study.
22) The subject is incapable of or restricted to the protocol-directed examinations or procedures.
23) The subject is considered by the investigator, for any other reason, to be unsuitable for participating in this study.
24) Not willing and able to use a reliable and acceptable contraceptive method (Pearl Index < 1). The subjects or their sexual partners, respectively, must use at least one of these reliable methods from 6 weeks before until 3 weeks after the administration of the study medication.
25) For females: pregnancy or lactation
26) Co-worker, student, relative or spouse of the investigator


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

Health Condition(s) or Problem(s) studied

Ulcerative Colitis with active endoscopic lesion(s), ranging in severity from moderate to severe in endoscopic score not responding sufficiently to conventional treatment
MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

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

Intervention(s)

Product Name: STNM01 1.84 mg
Product Code: STNM01
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: STNM01
Current Sponsor code: STNM01
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.84-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Submucosal use

Primary Outcome(s)

Main Objective: The objective of this study is to investigate the efficacy and safety of a single dose of STNM01 when concomitantly administered with conventional treatment in patients with Ulcerative colitis who have active endoscopic lesion(s) and do not respond sufficiently to the conventional treatment.

Secondary Objective: NA

Primary end point(s): Assessment of efficacy:
Improvement of endoscopic lesions with respect to Mucosal healing by Mayo Endoscopic Subscore

Timepoint(s) of evaluation of this end point: Day 14 (Day 28)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Day 14; Day 28

Secondary end point(s): Assessment of efficacy:
Clinical response, change in Mayo Clinical Subscores
Change in Ulcerative Colonoscopic Index of Severity (UCCIS)
Histological response, change in Geboes Index
Assessment of safety:
Adverse events and adverse drug reactions

Secondary ID(s)

SIC002

Source(s) of Monetary Support

STELIC INSTITUTE & CO.