Dermatomyositis, Polymyositis, Sjogren's, SLE, SScPhase 1NCT02780674
A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
A Phase 1 study testing MEDI7734 in people with Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc, run by Amgen at 7 sites in United States.
Trial summary
To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc
- What is being tested?
- MEDI7734
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Aug 2016to 27 Nov 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 -
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Research Site
Anniston, Alabama, 36207
Research Site
Birmingham, Alabama, 35294
Research Site
Danbury, Connecticut, 6810
Research Site
DeBary, Florida, 32713
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Jacksonville, Florida, 32216
Research Site
Miami Springs, Florida, 33166
About this study
Official title: A Phase 1, Randomized, Blinded, Single-Dose, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.
Read the 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.
- Being tested
- MEDI7734, Placebo
- Keywords
- Polymyositis, dermatomyositis, Sjogren's syndrome, SLE, SSc
- Medical subject headings
- Dermatomyositis, Polymyositis, Sjogren's Syndrome, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI7734Biological
Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
PlaceboBiological
One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
| Study group | Role | What they receive |
|---|---|---|
| MEDI7734 | Active comparator | Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects. Receives: Biological: MEDI7734 |
| Placebo | Placebo comparator | One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 85
Secondary outcomes (6)
Anti-drug antibodies
Presence of anti-drug antibodies (ADA)
Measured: Day 85
Pharmacokinetics Cmax
Maximum concentration of drug achieved
Measured: Day 85
Pharmacokinetics Tmax
Time at which maximum concentration of drug is achieved
Measured: Day 85
Pharmacokinetic
Half Life
Measured: Day 85
Pharmacokinetic
AUC
Measured: Day 85
Pharmacodynamics
Blood levels of plasmacytoid cells.
Measured: Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study start26 Aug 2016
- Primary completion23 Oct 2017
- Study completion27 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatomyositis, Polymyositis, Sjogren's, SLE, SScStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780674
- Sponsor's protocol ID
- D6080C00001
- Status last verified
- Dec 2024
- First submitted
- 3 May 2016
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Single-Dose, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT02780674
- Acronym / sponsor ID
- D6080C00001
- Keywords
- Polymyositis, dermatomyositis, Sjogren's syndrome, SLE, SSc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 23 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDI7734 | Active comparator | Biological: MEDI7734Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects. |
| Placebo | Placebo comparator | Biological: PlaceboOne subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI7734Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects. | Biological | MEDI7734 |
| PlaceboOne subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects. | Biological | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Event
Time frame: 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.
6 secondary outcomes
Anti-drug antibodies
Time frame: Day 85
Pharmacokinetics Cmax
Time frame: Day 85
Pharmacokinetics Tmax
Time frame: Day 85
Pharmacokinetic
Time frame: Day 85
Pharmacokinetic
Time frame: Day 85
Pharmacodynamics
Time frame: Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI7734 in people with Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc, run by Amgen at 7 sites in United States.
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 4 inclusion and 9 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 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Incidence of Treatment-Emergent Adverse Event (time frame: Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2024.