NCT03543540

Brief Summary

A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

4 months

First QC Date

April 26, 2018

Last Update Submit

September 19, 2018

Conditions

Celiac DiseaseIntestinal DiseaseMalabsorption SyndromesGastrointestinal DiseaseDigestive System DiseasesMetabolic DiseaseCoeliac DiseaseGluten Sensitivity

Outcome Measures

Primary Outcomes (2)

  • Safety of Nexvax 2 administered subcutaneously (SQ)

    Treatment emergent adverse events (TEAEs) will be summarized by treatment group and treatment arm, severity (grades as defined in CTCAE, Version 4.03), relationship to IP, and phase of treatment and presented as the number and percentage of patients reporting an event(s) as well as the number of events reported.

    Treatment Period: 7 weeks

  • Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration

    Blood draws for plasma concentration

    Treatment Period: 7 weeks

Secondary Outcomes (4)

  • Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID

    Treatment Period: 7 weeks

  • Evaluate area under the plasma concentration-time curve for the constituents of Nexvax2 in SQ versus ID maintenance doses.

    Treatment Period: 7 weeks

  • Compare elimination half life properties for the constituents of Nexvax2 in SQ versus ID maintenance doses.

    Treatment Period: 7 weeks

  • Compare time to maximal plasma concentration for the constituents of Nexvax2 in SQ versus ID maintenance doses.

    Treatment Period: 7 weeks

Study Arms (4)

Nexvax2 (Arm A)

EXPERIMENTAL
Biological: Nexvax2

Nexvax2 (Arm B)

EXPERIMENTAL
Biological: Nexvax2

Nexvax2 Placebo (Arm C)

PLACEBO COMPARATOR
Biological: Placebo

Nexvax2 Placebo (Arm D)

PLACEBO COMPARATOR
Biological: Placebo

Interventions

Nexvax2BIOLOGICAL

Nexvax2 injections: 14 in total at twice weekly intervals

Nexvax2 (Arm A)Nexvax2 (Arm B)
PlaceboBIOLOGICAL

Placebo injections: 14 in total at twice weekly intervals

Nexvax2 Placebo (Arm C)Nexvax2 Placebo (Arm D)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 to 70 years of age (inclusive)
  • History of medically diagnosed Celiac Disease (CeD) that included duodenal biopsy.
  • Maintenance of gluten free diet (GFD) for at least 12 consecutive months prior to screening.
  • Willingness to consume a moderate amount of gluten on one occasion during screening.
  • Able to read and understand English.

You may not qualify if:

  • History of inflammatory bowel disease and/or microscopic colitis.
  • Any medical condition or lab abnormality that in the opinion of the investigator may interfere with study conduct or would impact the immune response (other than CeD), confound interpretation of study results, or pose an increased risk to the subject.
  • Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening
  • Use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable.
  • Receipt of any investigational drug or participation in another clinical study within 6 months prior to screening.
  • Females who are lactating or pregnant
  • Receipt of any vaccine within 1 week prior to planned first day of the treatment period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Qpharm Pty Ltd

Herston, Queensland, 4006, Australia

Location

University of the Sunshine Coast

Sippy Downs, Queensland, 4556, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Related Links

MeSH Terms

Conditions

Celiac DiseaseIntestinal DiseasesMalabsorption SyndromesGastrointestinal DiseasesDigestive System DiseasesMetabolic Diseases

Interventions

Nexvax2

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Robert Anderson, PhD, FRACP

    ImmusanT, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2018

First Posted

June 1, 2018

Study Start

May 1, 2018

Primary Completion

September 10, 2018

Study Completion

September 10, 2018

Last Updated

September 20, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(3)