InflammationPhase 1NCT01611688
First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis
A Phase 1 study testing NNC0215-0384 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this trial is to describe the safety and tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammation, Rheumatoid Arthritis
- What is being tested?
- NNC0215-0384
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jun 2012to 17 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active RA, characterised by a DAS28 (CRP)(Disease Activity Score based on 28 joints and CRP) above 3.2 and a minimum of two swollen joints based on a 68/66 joint count at screening
- Concomitant treatment with MTX (7.5 - 25 mg/week both inclusive) for at least 16 weeks, with a stable dose for at least 6 weeks prior to dosing
Who cannot join
- Subjects with chronic inflammatory autoimmune disease other than RA
- History of or current inflammatory joint disease other than RA such as gout (crystal proven), psoriatic arthritis, juvenile idiopathic arthritis, current reactive arthritis or Lyme disease
- Any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
- Clinically significant cardiac or cardiovascular disease
- Past or current malignancy
- Latent or active tuberculosis (TB) as documented by: A positive QuantiFeron® test (test can be performed up to 2 months prior to dosing). One retest is allowed in case of inconclusive results.- A history of active TB within the last 3 years even, if treated effectively. - A history of active TB more than 3 years ago, if there is no documentation that the prior anti-TB treatment was appropriate in duration and type
Trial locations and contacts
1 site in 1 country.
About this study
This trial is conducted in Europe. The aim of this trial is to describe the safety and tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment.
- Conditions
- Inflammation, Rheumatoid Arthritis
- Being tested
- NNC0215-0384, placebo
- Medical subject headings
- Inflammation, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0215-0384Drug
I.v.(intravenous) dose-escalation. Highest dose planned for i.v. administration is 10 mg/kg
placeboDrug
Administered i.v.(intravenous) or s.c. (subcutaneous, under the skin).
NNC0215-0384Drug
The s.c. (subcutaneous, under the skin) part will not start until at least two i.v. dose levels have been evaluated for safety and pharmacokinetics. Highest dose planned for s.c. administration is 4 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: NNC0215-0384 |
| 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: Up to 10 weeks after trial product administration
Secondary outcomes (6)
I.v. administration: AUC, Area under the curve
Measured: Up to 10 weeks after drug administration
I.v. administration: terminal half-life (t½)
Measured: Up to 10 weeks after drug administration
S.c. administration: AUC, Area under the curve
Measured: Up to 10 weeks after drug administration
S.c. administration: terminal half-life (t½)
Measured: Up to 10 weeks after drug administration
Maximum level and duration of full C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils
Measured: Up to 10 weeks after drug administration
Maximum and minimum levels of relevant serum and plasma biomarkers related to NNC0215-0384 safety, efficacy or mechanism of action (MoA)
Measured: Up to 10 weeks after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study start4 Jun 2012
- Primary completion17 Jun 2013
- Study completion17 Jun 2013
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
- 36 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
- NCT01611688
- Sponsor's protocol ID
- NN8210-3926
- Other IDs
- 2011-003008-19, U1111-1122-3474
- Status last verified
- Feb 2017
- First submitted
- 1 Jun 2012
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01611688
- Acronym / sponsor ID
- NN8210-3926
- Conditions
- Inflammation, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2012 (actual)
- Primary completion
- 17 Jun 2013 (actual)
- Study completion
- 17 Jun 2013 (actual)
- First posted
- 5 Jun 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. The aim of this trial is to describe the safety and tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: NNC0215-0384 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Active RA, characterised by a DAS28 (CRP)(Disease Activity Score based on 28 joints and CRP) above 3.2 and a minimum of two swollen joints based on a 68/66 joint count at screening
- Concomitant treatment with MTX (7.5 - 25 mg/week both inclusive) for at least 16 weeks, with a stable dose for at least 6 weeks prior to dosing
Key exclusion criteria (6 listed)
- Subjects with chronic inflammatory autoimmune disease other than RA
- History of or current inflammatory joint disease other than RA such as gout (crystal proven), psoriatic arthritis, juvenile idiopathic arthritis, current reactive arthritis or Lyme disease
- Any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
- Clinically significant cardiac or cardiovascular disease
- Past or current malignancy
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 |
|---|---|---|
| NNC0215-0384I.v.(intravenous) dose-escalation. Highest dose planned for i.v. administration is 10 mg/kg | Drug | Active |
| placeboAdministered i.v.(intravenous) or s.c. (subcutaneous, under the skin). | Drug | Placebo |
| NNC0215-0384The s.c. (subcutaneous, under the skin) part will not start until at least two i.v. dose levels have been evaluated for safety and pharmacokinetics. Highest dose planned for s.c. administration is 4 mg/kg | Drug | Active |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 10 weeks after trial product administration
6 secondary outcomes
I.v. administration: AUC, Area under the curve
Time frame: Up to 10 weeks after drug administration
I.v. administration: terminal half-life (t½)
Time frame: Up to 10 weeks after drug administration
S.c. administration: AUC, Area under the curve
Time frame: Up to 10 weeks after drug administration
S.c. administration: terminal half-life (t½)
Time frame: Up to 10 weeks after drug administration
Maximum level and duration of full C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils
Time frame: Up to 10 weeks after drug administration
Maximum and minimum levels of relevant serum and plasma biomarkers related to NNC0215-0384 safety, efficacy or mechanism of action (MoA)
Time frame: Up to 10 weeks after drug administration
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 27 Feb 2017.
- 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 NNC0215-0384 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 1 site in Germany.
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 2 inclusion and 6 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 27 Feb 2017. 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 Germany. 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?
Incidence of adverse events (AEs) (time frame: Up to 10 weeks after trial product administration). 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 27 Feb 2017.