InflammationPhase 1NCT01018238
An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing NNC 0151-0000-0000 in people with Inflammation and Systemic Lupus Erythematosus, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of increasing repeated doses of NNC 151-0000-0000 in subjects with Systemic Lupus Erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammation, Systemic Lupus Erythematosus
- What is being tested?
- NNC 0151-0000-0000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Nov 2009
- 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
- Diagnosis of systemic lupus erythematosus (SLE)
- Disease duration: 6 months or longer
- Stable, mild to moderately active systemic lupus erythematosus (SLE)
- Receiving stable maintenance therapy
Who cannot join
- Significant Lupus Nephritis
- Active central nervous system (CNS) disease
- Significant arterial or venous thrombosis (blood clots) within 12 months prior to trial start
- Body weight of 260 lbs/120 kg or more
- History of alcohol or substance abuse
- History of cancer
Show all 11Show fewer
- Infections
- Viral infections: HIV, Hepatitis B or C, Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), Varicella-Zoster Virus (VZV), or Herpes Simplex Virus (HSV-1 or HSV-2)
- Tuberculosis
- Severe systemic bacterial, viral or fungal infections within the past 12 months prior to trial start
- Immunosuppressive and immune modulating therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Clinical Trial Call Center
Lake Success, New York, 11042-1008
About this study
Official title: A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE)
This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of increasing repeated doses of NNC 151-0000-0000 in subjects with Systemic Lupus Erythematosus (SLE).
Read the detailed description
The trial was terminated before any patients were exposed to the trial drug based on new findings indicating that dose escalation with multiple doses should be performed in a different trial population.
- Conditions
- Inflammation, Systemic Lupus Erythematosus
- Being tested
- NNC 0151-0000-0000, placebo
- Medical subject headings
- Inflammation, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC 0151-0000-0000Drug
Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)
placeboDrug
Multiple doses of placebo (no active ingredients) administered subcutaneously (under the skin)
| Study group | Role | What they receive |
|---|---|---|
| Placebo arm | Placebo comparator | Not described Receives: Drug: placebo |
| Cohort 1 | Experimental | Not described Receives: Drug: NNC 0151-0000-0000 |
| Cohort 2 | Experimental | Not described Receives: Drug: NNC 0151-0000-0000 |
| Cohort 3 | Experimental | Not described Receives: Drug: NNC 0151-0000-0000 |
| Cohort 4 | Experimental | Not described Receives: Drug: NNC 0151-0000-0000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed adverse events
Measured: From day -28 to day 113
Secondary outcomes (4)
Number of adverse Events (including injection site reactions)
Measured: Every visit through study completion (Day 113)
Pharmacokinetics: terminal half-life, trough values, serum concentrations
Measured: Day 1 through Day 113
Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies
Measured: Day 1 through Day 113
Clinical disease endpoints: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), British Isles Lupus Assessment Group (BILAG), and Quality of Life by use of SF-36 (QOL)
Measured: Day 1 through Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: See detailed description
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018238
- Sponsor's protocol ID
- NN8209-3608
- Other IDs
- U1111-1112-1881
- Status last verified
- Jul 2014
- First submitted
- 16 Nov 2009
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT01018238
- Acronym / sponsor ID
- NN8209-3608
- Conditions
- Inflammation, Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: See detailed description
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 23 Nov 2009 (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 trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of increasing repeated doses of NNC 151-0000-0000 in subjects with Systemic Lupus Erythematosus (SLE).
Detailed description
The trial was terminated before any patients were exposed to the trial drug based on new findings indicating that dose escalation with multiple doses should be performed in a different trial population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo arm | Placebo comparator | Drug: placebo |
| Cohort 1 | Experimental | Drug: NNC 0151-0000-0000 |
| Cohort 2 | Experimental | Drug: NNC 0151-0000-0000 |
| Cohort 3 | Experimental | Drug: NNC 0151-0000-0000 |
| Cohort 4 | Experimental | Drug: NNC 0151-0000-0000 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of systemic lupus erythematosus (SLE)
- Disease duration: 6 months or longer
- Stable, mild to moderately active systemic lupus erythematosus (SLE)
- Receiving stable maintenance therapy
Key exclusion criteria (11 listed)
- Significant Lupus Nephritis
- Active central nervous system (CNS) disease
- Significant arterial or venous thrombosis (blood clots) within 12 months prior to trial start
- Body weight of 260 lbs/120 kg or more
- History of alcohol or substance abuse
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 |
|---|---|---|
| NNC 0151-0000-0000Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin) | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| placeboMultiple doses of placebo (no active ingredients) administered subcutaneously (under the skin) | Drug | Placebo arm |
Primary outcome
Observed adverse events
Time frame: From day -28 to day 113
4 secondary outcomes
Number of adverse Events (including injection site reactions)
Time frame: Every visit through study completion (Day 113)
Pharmacokinetics: terminal half-life, trough values, serum concentrations
Time frame: Day 1 through Day 113
Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies
Time frame: Day 1 through Day 113
Clinical disease endpoints: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), British Isles Lupus Assessment Group (BILAG), and Quality of Life by use of SF-36 (QOL)
Time frame: Day 1 through Day 113
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Clinical Trials at Novo NordiskLink 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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC 0151-0000-0000 in people with Inflammation and Systemic Lupus Erythematosus, run by Novo Nordisk A/S at 1 site 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 11 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: withdrawn, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
Observed adverse events (time frame: From day -28 to day 113). 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 15 Aug 2014.