Dendritic Cell -Mediated Rheumatic DiseasesPhase 1NCT04948099
A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases
A Phase 1 study testing VIB1116 in people with Dendritic Cell -Mediated Rheumatic Diseases, run by Amgen at 11 sites in 2 countries.
Trial summary
A first-in-human study to evaluate the safety and tolerability of escalating, single and multiple ascending doses of VIB1116 in adult participants with rheumatic diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dendritic Cell -Mediated Rheumatic Diseases
- What is being tested?
- VIB1116
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 6 Jul 2021to 3 Jul 2023
- 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
- Male or female ≥ 18 years of age and ≤ 60 years of age and a body mass index (BMI) < 30 kg/m² or, in patients who have completed dosing with a vaccine against COVID-19 and are at least 1 month post the last dose, ≤ 65 years of age and BMI < 35 kg/m^2
- A diagnosis of one of a specified list of rheumatologic diseases at least 6 months prior to screening.
- Stable dosing (or no use) of glucocorticoid or disease-modifying antirheumatic drugs (DMARDs) used for treatment of rheumatologic disease for ≥ 28 days prior to randomization.
- Willing to practice study-required contraception.
Who cannot join
- Planning to change treatment for rheumatologic disorder within 4 months after randomization
- Known immunodeficiency disorder or history of splenectomy, organ or cell-based transplantation, total lymphoid irradiation or T-cell vaccination or transfusion in prior 6 months
- Treatment with prednisone or equivalent at a dose > 10 mg/day or intraarticular, intravenous or intramuscular steroids within 28 days prior to screening
- Treatment with any of the following medications within 28 days prior to screening (unless otherwise specified below) above the given doses:
- Mycophenolate mofetil > 2 g/day
- Methotrexate > 20 mg/week
Show all 30Show fewer
- Leflunomide > 20 mg/day within 6 months prior to screening or receipt of leflunomide in combination with any dose of methotrexate
- Azathioprine > 2 mg/kg/day
- Cyclosporine (except eye drops); tacrolimus (except topical), sirolimus, thalidomide, lenalidomide, 6-mercaptopurine, or voclosporin
- Hydroxychloroquine > 400 mg/day
- Chloroquine > 250 mg/day
- Quinacrine > 100 mg/day
- Sulfasalazine > 3 g/day, except that no more than 1 g/day is permitted if used in combination with methotrexate
- Dapsone > 100 mg/day
- Danazol > 800 mg/day
- Any other nonbiologic immunosuppressive/immunomodulatory agent not already specified (eg, mizoribine, retinoids, adrenocorticotropic hormone analogs, dehydroepiandrosterone [DHEA]) within 2 weeks prior to screening.
- Receipt of any biologic B cell-depleting therapy within 12 months or non-depleting B cell-directed therapy within 6 months
- Receipt of abatacept, etanercept, or other biologic immunomodulatory agent or immunoglobulins within 3 months
- Receipt of any other biologic disease modifying antirheumatic drug (bDMARD) not already specified, such as any targeted therapy (other than Janus kinase [JAK] inhibitor), or receipt of cyclophosphamide or chlorambucil within 6 months
- Receipt of JAK inhibitors within 3 months
- Receipt of anticoagulants other than anti-platelet drugs in prior 28 days
- Active malignancy, history of malignancy within prior 10 years (limited exceptions) or known first degree relative with a hereditary cancer syndrome unless the patient is known to be free of the predisposing genetic mutation
- Receipt of live vaccine or live therapeutic infectious agent within the 28 days prior to screening.
- Pregnancy, lactation, or planning to become pregnant or donate/retrieve eggs before the end of study follow-up.
- Hepatitis B or C infection, HIV infection, evidence of active TB or being at high risk for TB
- History of any severe herpes virus infection (including any history of severe Epstein-Barr virus, cytomegalovirus disease, end-organ disease, disseminated herpes simplex, disseminated zoster, or ophthalmic zoster) or > 1 episode of herpes zoster in the 2 years prior to screening and/or any opportunistic infection in the prior 2 years
- Infection requiring parenteral antimicrobial therapy within 60 days of screening or any clinically significant active or suspected infection ( within 28 days prior to screening
- History of anaphylaxis to any human immunoglobulin therapy or monoclonal antibody.
- Blood tests at screening (performed in the central laboratory) that meet study requirements including but not limited to normal coagulation testing and glomerular filtration rate < 50 mL/min/1.73
- High risk for COVID-19 or for severe COVID-19
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States8 sites
Pinnacle Research Group
Anniston, Alabama, 36207
Clinical Research of W FL
Clearwater, Florida, 33765-2616
Rheumatology Associates
Dallas, Texas, 75231
Altoona Clinical Research
Duncansville, Pennsylvania, 16635-8445
Jacksonville Clinical Research
Jacksonville, Florida, 32216-4362
Accurate Clinical Research
Lake Charles, Louisiana, 70605
SW Rheumatology Center
Mesquite, Texas, 75150-6919
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229-3539
Poland3 sites
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168
Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi
Poznan, Greater Poland Voivodeship, 61-545
ARS RHEUMATICA Sp. z o.o. REUMATIKA-Centrum Reumatologii NZOZ
Warsaw, Masovian Voivodeship, 02-691
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of VIB1116 in Conventional Dendritic Cell (cDC) and Plasmacytoid Dendritic Cell (pDC)-Mediated Rheumatic Diseases
A first-in-human study to evaluate the safety and tolerability of escalating, single and multiple ascending doses of VIB1116 in adult participants with rheumatic diseases.
Read the detailed description
Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
- Being tested
- VIB1116, Placebo
- Keywords
- Autoimmune disease, Rheumatic disease, Phase 1
- Medical subject headings
- Autoimmune Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIB1116Drug
VIB1116
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| VIB1116 | Experimental | Single dose of VIB1116, SC or IV administration.
Multiple doses of VIB1116, SC administration. Receives: Drug: VIB1116 |
| Placebo | Placebo comparator | Single dose of Placebo, SC or IV administration.
Multiple doses of Placebo, SC administration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest
Measured: Up to Day 141
Secondary outcomes (4)
Serum concentration of VIB1116 and noncompartmental PK parameters
Measured: Up to Day 141
Change from baseline in the blood levels of plasmacytoid dendritic cells
Measured: Up to Day 141
Percentage of Participants who are ADA (antidrug antibody) positive
Measured: Up to Day 141
Titer in ADA positive participants
Measured: Up to Day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start6 Jul 2021
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dendritic Cell -Mediated Rheumatic DiseasesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 73 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
- NCT04948099
- Sponsor's protocol ID
- VIB1116.P1.S1
- Status last verified
- Dec 2024
- First submitted
- 16 Jun 2021
- 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, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of VIB1116 in Conventional Dendritic Cell (cDC) and Plasmacytoid Dendritic Cell (pDC)-Mediated Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT04948099
- Acronym / sponsor ID
- VIB1116.P1.S1
- Keywords
- Autoimmune disease, Rheumatic disease, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 1 Jul 2021 (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.
A first-in-human study to evaluate the safety and tolerability of escalating, single and multiple ascending doses of VIB1116 in adult participants with rheumatic diseases.
Detailed description
Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIB1116 | Experimental | Drug: VIB1116Single dose of VIB1116, SC or IV administration. Multiple doses of VIB1116, SC administration. |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose of Placebo, SC or IV administration. Multiple doses of Placebo, SC administration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years of age and ≤ 60 years of age and a body mass index (BMI) < 30 kg/m² or, in patients who have completed dosing with a vaccine against COVID-19 and are at least 1 month post the last dose, ≤ 65 years of age and BMI < 35 kg/m^2
- A diagnosis of one of a specified list of rheumatologic diseases at least 6 months prior to screening.
- Stable dosing (or no use) of glucocorticoid or disease-modifying antirheumatic drugs (DMARDs) used for treatment of rheumatologic disease for ≥ 28 days prior to randomization.
- Willing to practice study-required contraception.
Key exclusion criteria (30 listed)
- Planning to change treatment for rheumatologic disorder within 4 months after randomization
- Known immunodeficiency disorder or history of splenectomy, organ or cell-based transplantation, total lymphoid irradiation or T-cell vaccination or transfusion in prior 6 months
- Treatment with prednisone or equivalent at a dose > 10 mg/day or intraarticular, intravenous or intramuscular steroids within 28 days prior to screening
- Treatment with any of the following medications within 28 days prior to screening (unless otherwise specified below) above the given doses:
- Hepatitis B or C infection, HIV infection, evidence of active TB or being at high risk for TB
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 |
|---|---|---|
| VIB1116VIB1116 | Drug | VIB1116 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest
Time frame: Up to Day 141
4 secondary outcomes
Serum concentration of VIB1116 and noncompartmental PK parameters
Time frame: Up to Day 141
Change from baseline in the blood levels of plasmacytoid dendritic cells
Time frame: Up to Day 141
Percentage of Participants who are ADA (antidrug antibody) positive
Time frame: Up to Day 141
Titer in ADA positive participants
Time frame: Up to Day 141
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
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
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIB1116 in people with Dendritic Cell -Mediated Rheumatic Diseases, run by Amgen at 11 sites in 2 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 4 inclusion and 30 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 11 sites in United States, Poland. 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?
Treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest (time frame: Up to Day 141). 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.