A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases

Phase 1

Completed

• Conditions: Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc
• Interventions: Biological: MEDI7734; Biological: Placebo

• Registration Number: NCT02780674
• Lead Sponsor: Amgen

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.

Detailed Description

MEDI7734 is a human monoclonal antibody that binds to and causes temporary depletion of plasmacytoid dendritic cells (pDCs), a type of white blood cell. The objectives of this study are to evaluate the safety, drug levels, and pDC levels in subjects who are given a single injection of MEDI7734 or a placebo.

The study will be conducted in subjects with at least one of the five following autoimmune diseases: dermatomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus, or systemic sclerosis.

After a screening period, subjects will be randomized in a 3:1 ratio to receive a single dose of MEDI7734 or matching placebo, administered as a subcutaneous (under the skin) injection. After that, subjects will be evaluated periodically at the study site over at least the next 85 days.

Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.

Study Timeline

• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-23
• Study Start: 2016-08-26
• Primary Completion: 2017-10-23
• Study Completion: 2017-11-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Age 18-65 years old
2. Diagnoses of dematomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus and/or systemic sclerosis based on standard criteria.
3. Weight 40-120kg
4. 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.

Key

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEDI7734	MEDI7734	Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
Placebo	Placebo	One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Event	Day 85	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics Tmax	Day 85	Time at which maximum concentration of drug is achieved
Anti-drug antibodies	Day 85	Presence of anti-drug antibodies (ADA)
Pharmacodynamics	Day 85	Blood levels of plasmacytoid cells.
Pharmacokinetics Cmax	Day 85	Maximum concentration of drug achieved
Pharmacokinetic	Day 85	AUC

Trial Locations

Locations (1)

Research Site; 🇺🇸 Duncansville, Pennsylvania, United States