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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02749630
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Crohn's Disease Drug: Placebo Drug: UTTR1147A Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 11, 2016
Actual Primary Completion Date : February 19, 2020
Actual Study Completion Date : February 19, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy Volunteer
Participants will be given escalating doses of UTTR1147A or Placebo intravenously
Drug: Placebo
Matching placebo to UTTR1147A administered intravenously

Drug: UTTR1147A
Escalating doses of intravenously administered UTTR1147A
Other Names:
  • RO7021610
  • RG7880
  • IL-22Fc

Experimental: Ulcerative Colitis
Participants will be given escalating doses of UTTR1147A or Placebo intravenously
Drug: Placebo
Matching placebo to UTTR1147A administered intravenously

Drug: UTTR1147A
Escalating doses of intravenously administered UTTR1147A
Other Names:
  • RO7021610
  • RG7880
  • IL-22Fc

Experimental: Crohn's Disease
Participants will be given escalating doses of UTTR1147A or Placebo intravenously
Drug: Placebo
Matching placebo to UTTR1147A administered intravenously

Drug: UTTR1147A
Escalating doses of intravenously administered UTTR1147A
Other Names:
  • RO7021610
  • RG7880
  • IL-22Fc




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: Up to Day 134 ]

Secondary Outcome Measures :
  1. Maximum Serum Concentration (Cmax) of UTTR1147A After the First and Last Dose [ Time Frame: Up to Day 134 ]
  2. Minimum (Trough) Serum Concentrations (Ctrough) of UTTR1147A Prior to the Second and Last Dose [ Time Frame: Up to Day 134 ]
  3. Total Serum Clearance (CL) of UTTR1147A [ Time Frame: Up to Day 134 ]
  4. Volume of Distribution (V) of UTTR1147A [ Time Frame: Up to Day 134 ]
  5. 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 ]
  6. Elimination Half-Life (t1/2) of UTTR1147A [ Time Frame: Up to Day 134 ]
  7. Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) in Serum [ Time Frame: Up to Day 134 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749630


Locations
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Germany
Charité Research Organisation GmbH
Berlin, Germany, 10117
United Kingdom
University Hospital Coventry
Coventry, United Kingdom, CV2 2DX
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02749630    
Other Study ID Numbers: GA29469
2015-002512-32 ( EudraCT Number )
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Ulcer
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes