Cutaneous LupusPhase 1NCT01164917
Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus
A Phase 1 study testing AMG811 in people with Cutaneous Lupus and Discoid Lupus, run by Amgen at 8 sites in United States.
Trial summary
This is a multi-center, randomized, double-blind, placebo-controlled, two-period, crossover study in which approximately 20 subjects with Discoid Lupus Erythematosus will be enrolled to receive AMG 811 and placebo in one of two sequences (ie, AMG 811 followed by placebo or placebo followed by AMG 811). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cutaneous Lupus, Discoid Lupus, Lupus
- What is being tested?
- AMG811
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2010to Mar 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, between the ages of 18 and 70 years of age, inclusive, at the time of randomization;
- Diagnosis of discoid lupus erythematosus (DLE) with or without SLE;
- Intolerance of anti-malarial therapy or ≥ 3 months of anti-malarial therapy with residual disease activity. The total CLASI activity must be ≥ 10;
- Stable dose of topical steroids no stronger than medium-potency (Class III or less) for ≥ 2 weeks and/or systemic immunosuppressive therapy at stable dose for ≥ 8 weeks prior to randomization (except for leflunomide which requires ≥ 12 weeks) are permitted;
- Oral prednisone ≤ 20 mg/day (or equivalent) is permitted; one increase or one decrease of ≤ 5 mg/day prednisone equivalent (not to exceed 20 mg/day) will be allowed within 30 days before randomization;
Who cannot join
- Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of DLE or SLE) that would, by its progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures per the investigator's discretion;
- History of malignancy;
- Signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic infection, or recent history of repeated infections;
- Subjects with evidence of past or active tuberculosis
- Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies (confirmed by PCR or RIBA) during the screening period;
- Receipt of a live vaccine within 3 months of study randomization and during the study;
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- Prior use of the following agents:
- Administration of an investigational biologic agent that primarily targets the immune system -
- Rituximab, Lymphostat-B, or TACl-Ig within 9 months prior to randomization (or comparable B cell depleting or B cell inhibiting biologics); Rituximab (or other depleting CD20 targeted agents) treated patients must demonstrate a return of CD19+ B cells to > 5/μL;
- CTLA4-Ig within 3 months prior to randomization;
- Other agents within 5 half-lives prior to randomization;
- Administration of cyclosporine, tacrolimus, sirolimus, IV immunoglobulin, and/or plasmapheresis within 3 months of randomization;
- Administration of thalidomide or lenalidomide within 3 months of randomization;
- Administration of oral or IV cyclophosphamide (or any other alkylating agent) within 9 months of randomization;
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Research Site
Ann Arbor, Michigan, 48103
Research Site
Atlanta, Georgia, 30322
Research Site
Dallas, Texas, 75231
Research Site
Durham, North Carolina, 27710
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Salt Lake City, Utah, 84107
Research Site
Santa Monica, California, 90404
Research Site
Stanford, California, 94305
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Dose, Two-period, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of AMG 811 in Subjects With Discoid Lupus Erythematosus
This is a multi-center, randomized, double-blind, placebo-controlled, two-period, crossover study in which approximately 20 subjects with Discoid Lupus Erythematosus will be enrolled to receive AMG 811 and placebo in one of two sequences (ie, AMG 811 followed by placebo or placebo followed by AMG 811).
- Conditions
- Cutaneous Lupus, Discoid Lupus, Lupus, Systemic Lupus Erythematosus
- Being tested
- AMG811, AMG811 Placebo
- Keywords
- Lupus, Discoid Lupus, Cutaneous Lupus
- Medical subject headings
- Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG811Drug
Twelve subjects will be randomized to receive AMG 811 in Period 1 and will receive AMG 811 Placebo in Period 2. The AMG 811 and AMG 811 Placebo will be administered by injection.
AMG811 PlaceboDrug
8 subjects will be randomized to receive AMG 811 Placebo in Period 1 and will receive AMG 811 in Period 2. The AMG 811 Placebo and AMG 811 will be administered by injection
| Study group | Role | What they receive |
|---|---|---|
| AMG811 | Active comparator | All will receive AMG 811, either on Day 1 or Day 85 Receives: Drug: AMG811 |
| AMG811 Placebo | Placebo comparator | All will receive placebo, either on Day 1 or Day 85 Receives: Drug: AMG811 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation: Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, ECGs and the development of anti-AMG811 antibodies
Measured: 197 days
Secondary outcomes (1)
PK parameters, Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score and IFN-gamma related gene expression in skin biopsy samples
Measured: 197 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2012
- Study completionMar 2013
Why it stopped: The 16 subjects enrolled in the study should enable Amgen to adequately assess safety and tolerabili
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous LupusStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 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
- NCT01164917
- Sponsor's protocol ID
- 20100011
- Status last verified
- Sep 2014
- First submitted
- 15 Jul 2010
- Last updated
- 16 Sep 2014
- Results posted
- No
Publications
Werth VP, Fiorentino D, Sullivan BA, Boedigheimer MJ, Chiu K, Wang C, Arnold GE, Damore MA, Bigler J, Welcher AA, Russell CB, Martin DA, Chung JB. Brief Report: Pharmacodynamics, Safety, and Clinical Efficacy of AMG 811, a Human Anti-Interferon-gamma Antibody, in Patients With Discoid Lupus Erythematosus. Arthritis Rheumatol. 2017 May;69(5):1028-1034. doi: 10.1002/art.40052. Epub 2017 Mar 31.
PubMed 28118537
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Dose, Two-period, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of AMG 811 in Subjects With Discoid Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01164917
- Acronym / sponsor ID
- 20100011
- Conditions
- Cutaneous Lupus, Discoid Lupus, Lupus, Systemic Lupus Erythematosus
- Keywords
- Lupus, Discoid Lupus, Cutaneous Lupus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The 16 subjects enrolled in the study should enable Amgen to adequately assess safety and tolerabili
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Jul 2010 (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.
This is a multi-center, randomized, double-blind, placebo-controlled, two-period, crossover study in which approximately 20 subjects with Discoid Lupus Erythematosus will be enrolled to receive AMG 811 and placebo in one of two sequences (ie, AMG 811 followed by placebo or placebo followed by AMG 811).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG811 | Active comparator | Drug: AMG811All will receive AMG 811, either on Day 1 or Day 85 |
| AMG811 Placebo | Placebo comparator | Drug: AMG811 PlaceboAll will receive placebo, either on Day 1 or Day 85 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, between the ages of 18 and 70 years of age, inclusive, at the time of randomization;
- Diagnosis of discoid lupus erythematosus (DLE) with or without SLE;
- Intolerance of anti-malarial therapy or ≥ 3 months of anti-malarial therapy with residual disease activity. The total CLASI activity must be ≥ 10;
- Stable dose of topical steroids no stronger than medium-potency (Class III or less) for ≥ 2 weeks and/or systemic immunosuppressive therapy at stable dose for ≥ 8 weeks prior to randomization (except for leflunomide which requires ≥ 12 weeks) are permitted;
- Oral prednisone ≤ 20 mg/day (or equivalent) is permitted; one increase or one decrease of ≤ 5 mg/day prednisone equivalent (not to exceed 20 mg/day) will be allowed within 30 days before randomization;
Key exclusion criteria (14 listed)
- Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of DLE or SLE) that would, by its progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures per the investigator's discretion;
- History of malignancy;
- Signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic infection, or recent history of repeated infections;
- Subjects with evidence of past or active tuberculosis
- Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies (confirmed by PCR or RIBA) during the screening period;
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 |
|---|---|---|
| AMG811Twelve subjects will be randomized to receive AMG 811 in Period 1 and will receive AMG 811 Placebo in Period 2. The AMG 811 and AMG 811 Placebo will be administered by injection. | Drug | AMG811 |
| AMG811 Placebo8 subjects will be randomized to receive AMG 811 Placebo in Period 1 and will receive AMG 811 in Period 2. The AMG 811 Placebo and AMG 811 will be administered by injection | Drug | AMG811 Placebo |
Primary outcome
Safety evaluation: Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, ECGs and the development of anti-AMG811 antibodies
Time frame: 197 days
1 secondary outcome
PK parameters, Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score and IFN-gamma related gene expression in skin biopsy samples
Time frame: 197 days
Results and safety
The study was stopped early (reason given: The 16 subjects enrolled in the study should enable Amgen to adequately assess safety and tolerabili). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
- Derived from this study: PubMed 28118537Werth VP, Fiorentino D, Sullivan BA, Boedigheimer MJ, Chiu K, Wang C, Arnold GE, Damore MA, Bigler J, Welcher AA, Russell CB, Martin DA, Chung JB. Brief Report: Pharmacodynamics, Safety, and Clinical Efficacy of AMG 811, a Human Anti-Interferon-gamma Antibody, in Patients With Discoid Lupus Erythematosus. Arthritis Rheumatol. 2017 May;69(5):1028-1034. doi: 10.1002/art.40052. Epub 2017 Mar 31.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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
8 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 AMG811 in people with Cutaneous Lupus and Discoid Lupus, run by Amgen at 8 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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 was stopped early (reason given: The 16 subjects enrolled in the study should enable Amgen to adequately assess safety and tolerabili). Results are not available in the source record.
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?
Safety evaluation: Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, ECGs and the development of anti-AMG811 antibodies (time frame: 197 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01164917, which also lists 1 linked publication.
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 16 Sep 2014.