NCT02780674

Brief Summary

To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

7 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

May 3, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 26, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2017

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

1.2 years

First QC Date

May 3, 2016

Last Update Submit

December 10, 2024

Conditions

Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc

Keywords

Polymyositis, dermatomyositis, Sjogren's syndrome, SLE, SSc

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Event

    The safety and tolerability of MEDI7734 as measured by the incidence of any adverse events that occur on or after the day of administration of investigational product through the end of follow-up. Laboratory measurements, vital sign measurements, and electrocardiogram (ECG) parameters will also be evaluated as part of safety.

    Day 85

Secondary Outcomes (6)

  • Anti-drug antibodies

    Day 85

  • Pharmacokinetics Cmax

    Day 85

  • Pharmacokinetics Tmax

    Day 85

  • Pharmacokinetic

    Day 85

  • Pharmacokinetic

    Day 85

  • +1 more secondary outcomes

Other Outcomes (1)

  • Type I Interferon signature

    Day 85

Study Arms (2)

MEDI7734

ACTIVE COMPARATOR

Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.

Biological: MEDI7734

Placebo

PLACEBO COMPARATOR

One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.

Biological: Placebo

Interventions

MEDI7734BIOLOGICAL

Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.

MEDI7734
PlaceboBIOLOGICAL

One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years old
  • Diagnoses of dematomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus and/or systemic sclerosis based on standard criteria.
  • Weight 40-120kg
  • Stable disease such that in the opinion of the investigator it is unlikely that a change in subject's therapeutic regimen would be required during the subsequent 3 months.

You may not qualify if:

  • History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.
  • Chronic hepatitis B, chronic hepatitis C, or HIV infection.
  • History of latent or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening.
  • Herpes zoster infection within 3 months before randomization
  • Any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide \> 20 mg/day, abatacept.
  • Receipt of a mAb within 5 published half-lives prior to Day 1.
  • Receipt of rituximab or an experimental B-cell depleting mAb within 6 months of Day 1.
  • Receipt of rituximab or an experimental B-cell depleting mAb without return of CD19 or CD20 count to above the lower limit of normal.
  • Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, or T-cell vaccination therapy -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Anniston, Alabama, 36207, United States

Location

Research Site

Birmingham, Alabama, 35294, United States

Location

Research Site

Danbury, Connecticut, 6810, United States

Location

Research Site

DeBary, Florida, 32713, United States

Location

Research Site

Jacksonville, Florida, 32216, United States

Location

Research Site

Miami Springs, Florida, 33166, United States

Location

Research Site

Duncansville, Pennsylvania, 16635, United States

Location

MeSH Terms

Conditions

DermatomyositisPolymyositisSjogren's SyndromeLupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

MyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesArthritis, RheumatoidArthritisJoint DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 23, 2016

Study Start

August 26, 2016

Primary Completion

October 23, 2017

Study Completion

November 27, 2017

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. Additional information can be found on astrazenecaclinicaltrials.com.

Locations

US(7)