InflammationPhase 1NCT01689025
An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing NNC0114-0006 in people with Inflammation and Systemic Lupus Erythematosus, run by Novo Nordisk A/S at 5 sites in 4 countries.
Trial summary
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Inflammation, Systemic Lupus Erythematosus
- What is being tested?
- NNC0114-0006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Sep 2012to Feb 2014
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women (not pregnant and not nursing)
- Subjects with SLE meeting the American College of Rheumatology (ACR) criteria, with a disease duration of at least 6 months
- Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA)
- If taken, background medication must be stable
Who cannot join
- Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months
- Body mass index (BMI) below 18 kg/m^2 or above 38 kg/m^2
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
Novo Nordisk Clinical Trial Call Center
Houston, Texas, 77034
Novo Nordisk Clinical Trial Call Center
La Jolla, California, 92093
About this study
Official title: A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.
- Conditions
- Inflammation, Systemic Lupus Erythematosus
- Being tested
- NNC0114-0006, 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.
NNC0114-0006Drug
Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.
placeboDrug
Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.
| Study group | Role | What they receive |
|---|---|---|
| NNC0114-0006 | Experimental | Not described Receives: Drug: NNC0114-0006 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: From first administration of the trial product and up to week 26
Secondary outcomes (5)
PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)
Measured: After the last dosing (Week 6)
PK endpoint from serum NNC0114-0006: Accumulation based on the concentration
Measured: 2 weeks after the first (week 2) and the last dose (week 8)
Change in serum levels of total IL-21 (Interleukin-21)
Measured: Week 0, week 26
Change in disease activity (SELENA-SLEDAI)
Measured: Week 0, week 12
Change in corticosteroid usage
Measured: Week 0, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2014
- Study completionFeb 2014
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 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
- NCT01689025
- Sponsor's protocol ID
- NN8828-4002
- Other IDs
- 2011-005699-41, U1111-1125-9646
- Status last verified
- Apr 2014
- First submitted
- 14 Sep 2012
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01689025
- Acronym / sponsor ID
- NN8828-4002
- Conditions
- Inflammation, Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Sep 2012 (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 Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0114-0006 | Experimental | Drug: NNC0114-0006 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women (not pregnant and not nursing)
- Subjects with SLE meeting the American College of Rheumatology (ACR) criteria, with a disease duration of at least 6 months
- Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA)
- If taken, background medication must be stable
Key exclusion criteria (2 listed)
- Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months
- Body mass index (BMI) below 18 kg/m^2 or above 38 kg/m^2
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 |
|---|---|---|
| NNC0114-0006Administered subcutaneously (s.c., under the skin) every second week to a total of four doses. | Drug | NNC0114-0006 |
| placeboAdministered subcutaneously (s.c., under the skin) every second week to a total of four doses. | Drug | Placebo |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: From first administration of the trial product and up to week 26
5 secondary outcomes
PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)
Time frame: After the last dosing (Week 6)
PK endpoint from serum NNC0114-0006: Accumulation based on the concentration
Time frame: 2 weeks after the first (week 2) and the last dose (week 8)
Change in serum levels of total IL-21 (Interleukin-21)
Time frame: Week 0, week 26
Change in disease activity (SELENA-SLEDAI)
Time frame: Week 0, week 12
Change in corticosteroid usage
Time frame: Week 0, week 12
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 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
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0114-0006 in people with Inflammation and Systemic Lupus Erythematosus, run by Novo Nordisk A/S at 5 sites in 4 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 2 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 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Hungary, Poland, Serbia. 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. 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?
Incidence of Adverse Events (AEs) (time frame: From first administration of the trial product and up to week 26). 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 8 Apr 2014.