A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)

Ulcerative Colitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749630
• Other study ID #: GA29469
• Secondary ID: 2015-002512-32
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2016
• Est. completion date: February 19, 2020

Study information

• Verified date: October 2020
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, observer-blinded, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV) UTTR1147A. The study will consist of a repeat dose escalation in HVs, in participants with UC, and in participants with CD across multiple sites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 19, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Placebo
Matching placebo to UTTR1147A administered intravenously
• UTTR1147A
Escalating doses of intravenously administered UTTR1147A

Locations

Country	Name	City	State
Germany	Charité Research Organisation GmbH	Berlin
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events		Up to Day 134
Secondary	Maximum Serum Concentration (Cmax) of UTTR1147A After the First and Last Dose		Up to Day 134
Secondary	Minimum (Trough) Serum Concentrations (Ctrough) of UTTR1147A Prior to the Second and Last Dose		Up to Day 134
Secondary	Total Serum Clearance (CL) of UTTR1147A		Up to Day 134
Secondary	Volume of Distribution (V) of UTTR1147A		Up to Day 134
Secondary	Area Under the Concentration vs. Time Curve (AUC) Within a Dose Interval (AUCtau) After the Final Dose of UTTR1147A		Up to Day 134
Secondary	Elimination Half-Life (t1/2) of UTTR1147A		Up to Day 134
Secondary	Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) in Serum		Up to Day 134