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Ulcerative ColitisPhase 1NCT02749630

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

A Phase 1 study testing UTTR1147A in people with Ulcerative Colitis and Crohn's Disease, run by Genentech, Inc. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Ulcerative Colitis, Crohn's Disease
What is being tested?
UTTR1147A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
2 sitesin 2 countries
Study dates
11 Apr 2016to 19 Feb 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • Charité Research Organisation GmbH

    Berlin, 10117

Other trials in Germany

United Kingdom1 site

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

About this study

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

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.

Being tested
Placebo, UTTR1147A
Medical subject headings
Colitis, Ulcerative, Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Matching placebo to UTTR1147A administered intravenously

  • UTTR1147ADrug

    Also called efmarodocokin alfa, RO7021610, RG7880, IL-22Fc

    Escalating doses of intravenously administered UTTR1147A

Study groups in NCT02749630
Study groupRoleWhat they receive
Healthy VolunteerExperimentalParticipants will be given escalating doses of UTTR1147A or Placebo intravenously
Receives: Drug: Placebo; Drug: UTTR1147A
Ulcerative ColitisExperimentalParticipants will be given escalating doses of UTTR1147A or Placebo intravenously
Receives: Drug: Placebo; Drug: UTTR1147A
Crohn's DiseaseExperimentalParticipants will be given escalating doses of UTTR1147A or Placebo intravenously
Receives: Drug: Placebo; Drug: UTTR1147A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Adverse Events

    Measured: Up to Day 134

Secondary outcomes (7)

  1. Maximum Serum Concentration (Cmax) of UTTR1147A After the First and Last Dose

    Measured: Up to Day 134

  2. Minimum (Trough) Serum Concentrations (Ctrough) of UTTR1147A Prior to the Second and Last Dose

    Measured: Up to Day 134

  3. Total Serum Clearance (CL) of UTTR1147A

    Measured: Up to Day 134

  4. Volume of Distribution (V) of UTTR1147A

    Measured: Up to Day 134

  5. Area Under the Concentration vs. Time Curve (AUC) Within a Dose Interval (AUCtau) After the Final Dose of UTTR1147A

    Measured: Up to Day 134

  6. Elimination Half-Life (t1/2) of UTTR1147A

    Measured: Up to Day 134

  7. Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) in Serum

    Measured: Up to Day 134

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2016 (estimated)
  2. Study start11 Apr 2016
  3. Primary completion19 Feb 2020
  4. Study completion19 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02749630
Sponsor's protocol ID
GA29469
Other IDs
2015-002512-32, 2015
Status last verified
Oct 2020
First submitted
12 Apr 2016
Last updated
30 Oct 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wagner F, Mansfield JC, Lekkerkerker AN, Wang Y, Keir M, Dash A, Butcher B, Harder B, Orozco LD, Mar JS, Chen H, Rothenberg ME. Dose escalation randomised study of efmarodocokin alfa in healthy volunteers and patients with ulcerative colitis. Gut. 2023 Aug;72(8):1451-1461. doi: 10.1136/gutjnl-2022-328387. Epub 2023 Feb 2.

    PubMed 36732049

  • 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.

    PubMed 31792136

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UTTR1147A in people with Ulcerative Colitis and Crohn's Disease, run by Genentech, Inc. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Adverse Events (time frame: Up to Day 134). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02749630, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.

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