A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2015-002109-12-GB
• Date of registration: 29/12/2015
• Prospective Registration: Yes
• Primary sponsor: Arena Pharmaceuticals, Inc.
• Public title: A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)
• Scientific title: An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis
• Date of first enrolment: 14/03/2016
• Target sample size: 240
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002109-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Israel, Latvia, Lithuania, New Zealand, Poland, Romania, Russian Federation, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Chad Orevillo
• Affiliation: Arena Pharmaceuticals, Inc.

• Name: Chad Orevillo
• Affiliation: Arena Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Evidence of a personally signed and dated informed consent document
2. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and is deemed an appropriate candidate for participation in this long-term extension study
3. Eligible female patients must be:
a. non-pregnant, evidenced by a negative urine dipstick pregnancy test at Week 12 of study APD334-003
b. non-lactating
c. sexually abstinent (if this is the preferred and usual lifestyle of the individual. Periodic abstinence [calendar, symptothermal, post-ovulation methods], withdrawal [coitus interruptus], and lactational amenorrhoea method are not acceptable methods of contraception), surgically sterile, postmenopausal, or agree to continue to use an accepted method of birth control during and for at least 30 days after last study medication administration. Acceptable methods of birth control are:
- hormonal contraceptives (patients should be consistently taking the hormonal contraceptive for at least 3 months [90 days] prior to screening);
- double barrier method (condom and occlusive cap [diaphragm or cervical cap] with spermicide);
- an intrauterine device;
- surgical sterility for at least 6 months prior to screening for tubal ligation performed laparoscopically, hysterectomy and/or bilateral oophorectomy; and/or postmenopausal (defined as at least 2 years without menses).
Contraceptive measures such as Plan B (used after unprotected sex) are not acceptable methods of contraception for this study.
4. Eligible male patients must:
- Agree to use the double-barrier method (condom and occlusive cap [diaphragm or cervical cap] with spermicide) when sexually active with a female partner who is pregnant, breastfeeding, or not using an acceptable method of birth control, during the study and for 30 days after last study medication administration
5. Eligible male and female patients must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) for 30 days after the last dose of study drug
6. Completion of the APD334-003 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 216
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion criteria:
1. Patients who were withdrawn from study drug treatment due to any AE or SAE, or patients who did not complete the APD334-003 study
2. Female patients who wish to become pregnant
3. Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study


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

Health Condition(s) or Problem(s) studied

Ulcerative colitis
MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

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

Intervention(s)

Product Name: APD334
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not yet available
Other descriptive name: APD334
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

Primary end point(s): The primary endpoint for the study is long-term safety. The safety of APD334 will be monitored throughout the study with safety endpoints being as follows:
- Treatment-emergent adverse events (AEs) up to 30 days
following discontinuation of the study drug.
- Treatment-emergent serious adverse events (SAEs) up to 30 days following discontinuation of the study drug.

Timepoint(s) of evaluation of this end point: Monitored throughout study up to 30 days after discontinuation of study drug

Main Objective: To evaluate the long-term safety and tolerability and potential efficacy of APD334 in patients with ulcerative colitis who have completed the APD334-03 study.

Secondary Objective: To evaluate the effect of APD334 on achieving and maintaining clinical response and/or remission in patients with ulcerative colitis after 46 weeks of treatment.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Screening and Week 52

Secondary end point(s): In responders who transitioned from study APD334-003 to
APD334-005:
- The proportion of patients who maintain clinical response
[defined as a decrease in 3-component Mayo Clinic score of = 2
points and at least 30% with either a decrease of rectal bleeding
of = 1 or rectal bleeding score of 0 or 1] at Week 52 compared to
APD334-003 baseline
- The proportion of patients who achieve clinical remission
[defined as individual subscores of the 3-component Mayo
Clinic score as follows: an endoscopy score (using flexible
proctosigmoidoscopy) of 0 or 1, a rectal bleeding score of 0, and
a stool frequency score of 0 or 1 with a decrease of = 1 point
from baseline at Week 52 compared to APD334-003 baseline

Secondary ID(s)

APD334-005

2015-002109-12-LV

Source(s) of Monetary Support

Arena Pharmaceuticals, Inc.

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 28/10/2019
• Date Completed: 01/11/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-002109-12/results