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Completed

NCT Number: NCT02749630

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charité Research Organisation GmbH, Berlin, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Matching placebo to UTTR1147A administered intravenously

UTTR1147A

Drug

Escalating doses of intravenously administered UTTR1147A

Other names: efmarodocokin alfa, RO7021610, RG7880, IL-22Fc

Primary outcomes

  1. Percentage of Participants with Adverse Events

    Time frame: Up to Day 134

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2016
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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