Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT02749630 |
Date of registration:
|
12/04/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)
|
Scientific title:
|
An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's Disease |
Date of first enrolment:
|
April 11, 2016 |
Target sample size:
|
70 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02749630 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
Phase:
|
Phase 1
|
|
Countries of recruitment
|
Canada
|
Germany
|
United Kingdom
| | | | | |
Contacts
|
Name:
|
Clinical Trials |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Hoffmann-La Roche |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
General inclusion criteria:
- No history of malignancy
- Documentation of age-appropriate cancer screening based on local/country-specific
guidelines
- For women of childbearing potential: agreement to remain abstinent or use
contraceptive methods
- For men: agreement to remain abstinent or use contraceptive measures and agreement to
refrain from donating sperm
For HVs Only:
- Age 18 - 50
- Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m2), inclusive
- In good health, determined by no clinically significant findings from medical history,
12-lead electrocardiogram (ECG), and vital signs, and clinical laboratory evaluations
should be within the reference range for the test laboratory unless deemed not
clinically significant by the investigator and Sponsor
For Participants with UC or CD:
- Age 18 - 80
- Eligible to receive biologic therapy
- Disease duration of >/= 12 weeks
- Diagnosis of moderate to severe UC or CD
Exclusion Criteria:
General exclusion criteria:
- History of inflammatory skin disorders
- History of any cancer
- History of anaphylaxis, hypersensitivity, or drug allergies
- History of alcoholism or drug addiction
- Positive tests indicating infection for hepatitis C, hepatitis B, or HIV
- Use of a non-biologic investigational drug or participation in an investigational
study with a non-biologic drug within 30 days or 5 half-lives of investigational
product, whichever is greater, prior to study drug administration
- Use of a biologic investigational therapy or participation in an investigational study
involving biologic therapy within 90 days or 5 half-lives, whichever is greater, prior
to study drug administration
- History or presence of an abnormal ECG that is clinically significant in the
investigator's opinion
- Family history of sudden unexplained death or long QT syndrome
- Any acute or chronic condition that would limit the subject's ability to complete
and/or participate in this clinical study
- Pregnant or lactating, or intending to become pregnant for duration of study
For HVs Only:
- Known family history of gastrointestinal (GI) and/or colon cancer
- Prior exposure to UTTR1147A
For Participants with UC or CD:
- Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary,
renal, hepatic, endocrine, or GI disorders
- History of primary sclerosing cholangitis
- Active anti-TNF induced psoriasiform or eczematous lesions
- Moderate to severe anemia
- Presence of an ileostomy or colostomy
- Total proctocolectomy
- Positive screening for latent mycobacterial tuberculosis infection
- Impaired renal function
- Impared hepatic function
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Crohn's Disease
|
Ulcerative Colitis
|
Intervention(s)
|
Drug: Placebo
|
Drug: UTTR1147A
|
Primary Outcome(s)
|
Percentage of Participants with Adverse Events
[Time Frame: Up to Day 134]
|
Secondary Outcome(s)
|
Elimination Half-Life (t1/2) of UTTR1147A
[Time Frame: Up to Day 134]
|
Area Under the Concentration vs. Time Curve (AUC) Within a Dose Interval (AUCtau) After the Final Dose of UTTR1147A
[Time Frame: Up to Day 134]
|
Maximum Serum Concentration (Cmax) of UTTR1147A After the First and Last Dose
[Time Frame: Up to Day 134]
|
Total Serum Clearance (CL) of UTTR1147A
[Time Frame: Up to Day 134]
|
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) in Serum
[Time Frame: Up to Day 134]
|
Volume of Distribution (V) of UTTR1147A
[Time Frame: Up to Day 134]
|
Minimum (Trough) Serum Concentrations (Ctrough) of UTTR1147A Prior to the Second and Last Dose
[Time Frame: Up to Day 134]
|
Secondary ID(s)
|
2015-002512-32
|
GA29469
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|