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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 : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE April 12, 2016
First Posted Date  ICMJE April 25, 2016
Last Update Posted Date October 30, 2020
Actual Study Start Date  ICMJE April 11, 2016
Actual Primary Completion Date February 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
Percentage of Participants with Adverse Events [ Time Frame: Up to Day 134 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • Incidence, nature and severity of adverse events during and following administration of UTTR1147A [ Time Frame: Up to Day 134 ]
  • Changes in vital signs, physical exam findings, and laboratory abnormalities during and following administration of UTTR1147A [ Time Frame: Up to Day 134 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
  • Maximum Serum Concentration (Cmax) of UTTR1147A After the First and Last Dose [ 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 ]
  • Total Serum Clearance (CL) of UTTR1147A [ Time Frame: Up to Day 134 ]
  • Volume of Distribution (V) 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 ]
  • Elimination Half-Life (t1/2) of UTTR1147A [ Time Frame: Up to Day 134 ]
  • Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) in Serum [ Time Frame: Up to Day 134 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • Pharmacokinetics: Maximum serum concentrations (Cmax) of UTTR1147A in healthy volunteers and UC subjects [ Time Frame: Up to Day 134 ]
  • Pharmacokinetics: Minimum (through) serum concentrations (Cthrough) of UTTR1147A in healthy volunteers and UC subjects [ Time Frame: Up to Day 134 ]
  • Pharmacokinetics: Total serum clearance(CL) of UTTR1147A in healthy volunteers and UC subjects [ Time Frame: Up to Day 134 ]
  • Pharmacokinetics: Volume of distribution (V) of UTTR1147A in healthy volunteers and UC subjects [ Time Frame: Up to Day 134 ]
  • Pharmacokinetics: Area under the Curve (AUC) Dosing Interval of UTTR1147A in healthy volunteers and UC subjects [ Time Frame: Up to Day 134 ]
  • Pharmacokinetics: Elimination half-life (t1/2) of UTTR1147A in healthy volunteers and UC subjects [ Time Frame: Up to Day 134 ]
  • Immunogenicity: Incidence of Anti-Therapeutic Antibodies (ATAs) in serum [ Time Frame: Up to Day 134 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Ulcerative Colitis
  • Crohn's Disease
Intervention  ICMJE
  • Drug: Placebo
    Matching placebo to UTTR1147A administered intravenously
  • Drug: UTTR1147A
    Escalating doses of intravenously administered UTTR1147A
    Other Names:
    • efmarodocokin alfa
    • RO7021610
    • RG7880
    • IL-22Fc
Study Arms  ICMJE
  • Experimental: Healthy Volunteer
    Participants will be given escalating doses of UTTR1147A or Placebo intravenously
    Interventions:
    • Drug: Placebo
    • Drug: UTTR1147A
  • Experimental: Ulcerative Colitis
    Participants will be given escalating doses of UTTR1147A or Placebo intravenously
    Interventions:
    • Drug: Placebo
    • Drug: UTTR1147A
  • Experimental: Crohn's Disease
    Participants will be given escalating doses of UTTR1147A or Placebo intravenously
    Interventions:
    • Drug: Placebo
    • Drug: UTTR1147A
Publications * Powell N, Pantazi E, Pavlidis P, Tsakmaki A, Li K, Yang F, Parker A, Pin C, Cozzetto D, Minns D, Stolarczyk E, Saveljeva S, Mohamed R, Lavender P, Afzali B, Digby-Bell J, Tjir-Li T, Kaser A, Friedman J, MacDonald TT, Bewick GA, Lord GM. Interleukin-22 orchestrates a pathological endoplasmic reticulum stress response transcriptional programme in colonic epithelial cells. Gut. 2020 Mar;69(3):578-590. doi: 10.1136/gutjnl-2019-318483. Epub 2019 Dec 2. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2020)
70
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2016)
45
Actual Study Completion Date  ICMJE February 19, 2020
Actual Primary Completion Date February 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United Kingdom
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT02749630
Other Study ID Numbers  ICMJE GA29469
2015-002512-32 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP