Systemic Lupus ErythematosusPhase 1NCT03817424
A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
A Phase 1 study testing VIB7734 in people with Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus, run by Amgen at 30 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome
- What is being tested?
- VIB7734
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 13 Dec 2018to 20 Jul 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18 through 75 years at the time of screening
- Participants with at least one of the following diagnoses:
- Systemic Lupus Erythematosus
- Cutaneous lupus erythematosus, including acute CLE, subacute CLE, and discoid lupus erythematosus
- Sjogren's syndrome (for Cohort 1 only)
- Systemic sclerosis (for Cohort 1 only)
Show all 12Show fewer
- Probable or definite polymyositis (for Cohort 1 only)
- Probable or definite dermatomyositis (for Cohort 1 only)
- For Cohorts 2 and 3 only: Participants with CLASI activity score greater than or equal to (>=) 8 at both Visits 1 (screening) and 2 (baseline)
- For Cohorts 2 and 3 only: a skin lesion amenable to punch skin biopsy and willingness of the participant to undergo skin biopsy at two time points
- For Cohorts 2 and 3 only: photographs of skin lesions must be submitted for review to confirm the diagnosis of SLE or CLE with active skin lesions confirmation of the diagnosis by the central reviewer must be received prior to randomization
- Females of childbearing potential and nonsterilized males who are ready to use protocol defined contraception methods
Who cannot join
- Severe manifestations of the diseases under study that could impact the participant safety
- Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection, splenectomy, or any underlying condition that predisposes the participant to infection
- At screening, have adequate central laboratory test results: aspartate transaminase greater than (>) 2.5 x upper limit of normal (ULN); alanine transaminase >2.5 x ULN; total bilirubin 1.5 x ULN; total immunoglobulin < 500 gram/decilitre; neutrophil count less than (<) 1,000/μL; platelet count < 85,000/μL; haemoglobin < 10 g/dL; glycosylated haemoglobin > 8 percent (%); total lymphocyte count < 300 cells/mm^3; glomerular filtration rate < 50 mL/min/1.73 m^2; plasmacytoid dendritic cells (pDC) level < 0.02% of peripheral blood mononuclear cells (PBMCs)
- Positive test for chronic hepatitis B infection at screening and for hepatitis C virus antibody
- History of or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening; a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection per central laboratory; cancer; clinically significant cardiac disease
- Herpes zoster infection within 3 months before randomization and/or any severe herpes virus family infection at any time prior to randomization
Show all 10Show fewer
- Any acute illness or evidence of clinically significant active infection, such as fever >= 38.0 degrees Celsius (>= 100.5 degrees Fahrenheit) at screening (Visit 1) or Day 1 (Visit 2)
- Cohorts 2 and 3 only: use of Group 1 (super-high potency) or Group 2 (high potency) topical corticosteroids
- Receipt of a live-attenuated vaccine within 4 weeks prior to Day 1
- Cohorts 2 and 3 only: have received changing doses of mycophenolate mofetil, methotrexate, leflunomide, azathioprine, or non-steroidal topical immunosuppressants within 28 days before study Day 1 or changing doses of oral or topical corticosteroids within 14 days before study Day 1
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United States19 sites
Viela Bio Investigative Site
Allen, Texas, 75013
Viela Bio Investigative Site
Anniston, Alabama, 36201
Viela Bio Investigative Site
Birmingham, Alabama, 35294
Viela Bio Investigative Site
Charlotte, North Carolina, 28204
Viela Bio Investigative Site
Danbury, Connecticut, 06810
Viela Bio Investigative Site
Duncansville, Pennsylvania, 16635
Viela Bio Investigative Site
Durham, North Carolina, 27713
Viela Bio Investigative Site
Fort Lauderdale, Florida, 33309
Viela Bio Investigative Site
Great Neck, New York, 11021
Viela Bio Investigative Site
Hialeah, Florida, 33016
Viela Bio Investigative Site
Jacksonville, Florida, 32216
Viela Bio Investigative Site
Lawrenceville, Georgia, 30046
Viela Bio Investigative Site
Los Angeles, California, 90022
Viela Bio Investigative Site
Memphis, Tennessee, 38119
Viela Bio Investigative Site
Mesquite, Texas, 75150
Viela Bio Investigative Site
Miami Lakes, Florida, 33014
Viela Bio Investigative Site
Philadelphia, Pennsylvania, 19104
Viela Bio Investigative Site
St. Petersburg, Florida, 33710
Viela Bio Investigative Site
Upland, California, 91786
Poland7 sites
Viela Bio Investigative Site
Bialystok
Viela Bio Investigative Site
Bydgoszcz
Viela Bio Investigative Site
Krakow
Viela Bio Investigative Site
Poznan
Viela Bio Investigative Site
Rzeszów
Viela Bio Investigative Site
Warsaw
Viela Bio Investigative Site
Wroclaw
Spain4 sites
Viela Bio Investigative Site
Barcelona
Viela Bio Investigative Site
Bilbao
Viela Bio Investigative Site
Madrid
Viela Bio Investigative Site
Seville
About this study
Official title: A Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis.
Read the detailed description
This study will have 3 periods: screening, treatment period, and extended follow-up. The screening period is 28 days. A total of 32 participants will be enrolled in 3 cohorts with 8 participants in Cohort 1, and 12 participants each in Cohorts 2 and 3. In Cohort 1, participants will be randomized in a 3:1 ratio to receive VIB7734 or matching placebo by injection every 4 weeks (q4w) for a total of 3 doses on Days 1, 29, and 57. In Cohorts 2 and 3, participants diagnosed with lupus only will be randomized in a 2:1 ratio to receive VIB7734 or matching placebo by injection q4w for 3 doses on Days 1, 29, and 57. Participants will be followed until at least Day 141. After the Day 141 visit, participants will exit the study if participants meets adequate plasmacytoid dendritic cells (pDCs). If an adequate pDC level does not meet at Day 141 visit, the participant will continue the follow-up for pDC repletion until they meet the protocol defined adequate pDC level or Day 337 visit has been reached.
Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
- Conditions
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, Dermatomyositis
- Being tested
- VIB7734, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous, Sjogren's Syndrome, Scleroderma, Systemic, Polymyositis, Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIB7734Drug
Also called MEDI7734
Participants will receive VIB7734 via injection.
PlaceboDrug
Participants will receive placebo matching to VIB7734 via injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: VIB7734 Dose 1 | Experimental | Participants will receive VIB7734 Dose 1 via injection q4w for a total of 3 doses on Days 1, 29, and 57. Receives: Drug: VIB7734 |
| Cohort 2: VIB7734 Dose 2 | Experimental | Participants will receive VIB7734 Dose 2 via injection q4w for a total of 3 doses on Days 1, 29, and 57. Receives: Drug: VIB7734 |
| Cohort 3: VIB7734 Dose 3 | Experimental | Participants will receive VIB7734 Dose 3 via injection q4w for a total of 3 doses on Days 1, 29, and 57. Receives: Drug: VIB7734 |
| Placebo | Placebo comparator | Participants will receive placebo matching to VIB7734 via injection q4w for a total of 3 doses on Days 1, 29, and 57. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Measured: Day 1 up to Day 337
Number of Participants With Adverse Events of Special Interest (AESIs)
Measured: Day 1 up to Day 337
Number of Participants With Laboratory Abnormalities Reported as TEAEs
Measured: Day 1 up to Day 337
Number of Participants With Vital Sign Abnormalities Reported as TEAEs
Measured: Day 1 up to Day 337
Number of Participants With 12-Lead Electrocardiogram Abnormalities Reported as TEAEs
Measured: Day 1 up to Day 337
Secondary outcomes (7)
Maximum Observed Serum Concentration (Cmax) of VIB7734 Maximum Observed Serum Concentration (Cmax) of VIB7734
Measured: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
Area Under the Concentration-time Curve (AUC) of VIB7734
Measured: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
Systemic Clearance (CL) of VIB7734
Measured: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
Terminal Half-life (t1/2) of VIB7734
Measured: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
Number of Participants With Positive Anti-Drug Antibodies of VIB7734
Measured: Day 1 up to Day 309
Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score (Cohorts 2 and 3)
Measured: Day 1 up to Day 253
Blood Levels of pDCs
Measured: Day 1 up to Day 337
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start13 Dec 2018
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817424
- Sponsor's protocol ID
- VIB7734.P1b.S1
- Other IDs
- 2018-003767-60, 2018
- Status last verified
- Dec 2024
- First submitted
- 22 Jan 2019
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
- ClinicalTrials.gov ID
- NCT03817424
- Acronym / sponsor ID
- VIB7734.P1b.S1
- Conditions
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, Dermatomyositis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 25 Jan 2019 (actual)
- 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.
The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis.
Detailed description
This study will have 3 periods: screening, treatment period, and extended follow-up. The screening period is 28 days. A total of 32 participants will be enrolled in 3 cohorts with 8 participants in Cohort 1, and 12 participants each in Cohorts 2 and 3. In Cohort 1, participants will be randomized in a 3:1 ratio to receive VIB7734 or matching placebo by injection every 4 weeks (q4w) for a total of 3 doses on Days 1, 29, and 57. In Cohorts 2 and 3, participants diagnosed with lupus only will be randomized in a 2:1 ratio to receive VIB7734 or matching placebo by injection q4w for 3 doses on Days 1, 29, and 57. Participants will be followed until at least Day 141. After the Day 141 visit, participants will exit the study if participants meets adequate plasmacytoid dendritic cells (pDCs). If an adequate pDC level does not meet at Day 141 visit, the participant will continue the follow-up for pDC repletion until they meet the protocol defined adequate pDC level or Day 337 visit has been reached.
Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: VIB7734 Dose 1 | Experimental | Drug: VIB7734Participants will receive VIB7734 Dose 1 via injection q4w for a total of 3 doses on Days 1, 29, and 57. |
| Cohort 2: VIB7734 Dose 2 | Experimental | Drug: VIB7734Participants will receive VIB7734 Dose 2 via injection q4w for a total of 3 doses on Days 1, 29, and 57. |
| Cohort 3: VIB7734 Dose 3 | Experimental | Drug: VIB7734Participants will receive VIB7734 Dose 3 via injection q4w for a total of 3 doses on Days 1, 29, and 57. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matching to VIB7734 via injection q4w for a total of 3 doses on Days 1, 29, and 57. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants aged 18 through 75 years at the time of screening
- Participants with at least one of the following diagnoses:
- For Cohorts 2 and 3 only: Participants with CLASI activity score greater than or equal to (>=) 8 at both Visits 1 (screening) and 2 (baseline)
- For Cohorts 2 and 3 only: a skin lesion amenable to punch skin biopsy and willingness of the participant to undergo skin biopsy at two time points
- For Cohorts 2 and 3 only: photographs of skin lesions must be submitted for review to confirm the diagnosis of SLE or CLE with active skin lesions confirmation of the diagnosis by the central reviewer must be received prior to randomization
Key exclusion criteria (10 listed)
- Severe manifestations of the diseases under study that could impact the participant safety
- Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection, splenectomy, or any underlying condition that predisposes the participant to infection
- At screening, have adequate central laboratory test results: aspartate transaminase greater than (>) 2.5 x upper limit of normal (ULN); alanine transaminase >2.5 x ULN; total bilirubin 1.5 x ULN; total immunoglobulin < 500 gram/decilitre; neutrophil count less than (<) 1,000/μL; platelet count < 85,000/μL; haemoglobin < 10 g/dL; glycosylated haemoglobin > 8 percent (%); total lymphocyte count < 300 cells/mm^3; glomerular filtration rate < 50 mL/min/1.73 m^2; plasmacytoid dendritic cells (pDC) level < 0.02% of peripheral blood mononuclear cells (PBMCs)
- Positive test for chronic hepatitis B infection at screening and for hepatitis C virus antibody
- History of or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening; a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection per central laboratory; cancer; clinically significant cardiac disease
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 |
|---|---|---|
| VIB7734Also: MEDI7734Participants will receive VIB7734 via injection. | Drug | Cohort 1: VIB7734 Dose 1, Cohort 2: VIB7734 Dose 2, Cohort 3: VIB7734 Dose 3 |
| PlaceboParticipants will receive placebo matching to VIB7734 via injection. | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 up to Day 337
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Day 1 up to Day 337
Number of Participants With Laboratory Abnormalities Reported as TEAEs
Time frame: Day 1 up to Day 337
Number of Participants With Vital Sign Abnormalities Reported as TEAEs
Time frame: Day 1 up to Day 337
Number of Participants With 12-Lead Electrocardiogram Abnormalities Reported as TEAEs
Time frame: Day 1 up to Day 337
7 secondary outcomes
Maximum Observed Serum Concentration (Cmax) of VIB7734 Maximum Observed Serum Concentration (Cmax) of VIB7734
Time frame: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
Area Under the Concentration-time Curve (AUC) of VIB7734
Time frame: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
Systemic Clearance (CL) of VIB7734
Time frame: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
Terminal Half-life (t1/2) of VIB7734
Time frame: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
Number of Participants With Positive Anti-Drug Antibodies of VIB7734
Time frame: Day 1 up to Day 309
Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score (Cohorts 2 and 3)
Time frame: Day 1 up to Day 253
Blood Levels of pDCs
Time frame: Day 1 up to Day 337
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: No
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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
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIB7734 in people with Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus, run by Amgen at 30 sites in 3 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 12 inclusion and 10 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 30 sites in United States, Poland, Spain. 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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: Day 1 up to Day 337). The study lists 5 primary outcomes in all. 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.