InflammationPhase 1NCT00927927
First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
A Phase 1 study testing NNC0142-0002 in people with Inflammation and Rheumatoid Arthritis, run by Janssen Research & Development, LLC at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis. 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?
- NNC0142-0002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Dec 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration
- Aged between 18 and 75 years (both inclusive)
- Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
- Use of highly effective contraception during the trial (both males and females)
Who cannot join
- A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)
- An active or latent tuberculosis
- Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
- A known significant cardio-vascular disease
- Vaccination against live virus or bacteria within 4 weeks prior to randomization
- The use of concomitant medications that are prohibited in the trial (e.g., certain DMARDs (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
- A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B and/or hepatitis C, or tuberculosis skin test
- Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.
- Conditions
- Inflammation, Rheumatoid Arthritis
- Being tested
- NNC0142-0002, 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.
NNC0142-0002Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
NNC0142-0002Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
NNC0142-0002Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
NNC0142-0002Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
NNC0142-0002Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
NNC0142-0002Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
NNC0142-0002Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
NNC0142-0002Drug
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
placeboDrug
Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
NNC0142-0002Drug
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
NNC0142-0002Drug
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
NNC0142-0002Drug
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
NNC0142-0002Drug
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
NNC0142-0002Drug
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
placeboDrug
Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
| Study group | Role | What they receive |
|---|---|---|
| SD 0.0002 mg/kg | Experimental | Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg Receives: Drug: NNC0142-0002 |
| SD 0.0012 mg/kg | Experimental | Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg Receives: Drug: NNC0142-0002 |
| SD 0.007 mg/kg | Experimental | Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg Receives: Drug: NNC0142-0002 |
| SD 0.035 mg/kg | Experimental | Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg Receives: Drug: NNC0142-0002 |
| SD 0.175 mg/kg | Experimental | Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg Receives: Drug: NNC0142-0002 |
| SD 0.7 mg/kg | Experimental | Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg Receives: Drug: NNC0142-0002 |
| SD 2.5 mg/kg | Experimental | Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg Receives: Drug: NNC0142-0002 |
| SD 7.5 mg/kg | Experimental | Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg Receives: Drug: NNC0142-0002 |
| SD Placebo | Experimental | Subjects were injected once with placebo Receives: Drug: placebo |
| MD 0.02 mg/kg | Experimental | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg Receives: Drug: NNC0142-0002 |
| MD 0.3 mg/kg | Experimental | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg Receives: Drug: NNC0142-0002 |
| MD 1.0 mg/kg | Experimental | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg Receives: Drug: NNC0142-0002 |
| MD 1.6 mg/kg | Experimental | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg Receives: Drug: NNC0142-0002 |
| MD 4.0 mg/kg | Experimental | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg Receives: Drug: NNC0142-0002 |
| MD Placebo | Experimental | Subjects were injected biweekly four times with placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.
Measured: Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.
Secondary outcomes (1)
Area Under the Concentration-time Curve (AUC)
Systemic exposure to NNC0142-0002.
Measured: Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britta Væver Bysted, DVM, PhD, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927927
- Sponsor's protocol ID
- NN8555-3618
- Other IDs
- 2008-008703-18, 2008
- Status last verified
- Aug 2016
- First submitted
- 24 Jun 2009
- Last updated
- 3 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00927927
- Acronym / sponsor ID
- NN8555-3618
- Conditions
- Inflammation, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Posted 21 Oct 2013
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 clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| SD 0.0002 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg |
| SD 0.0012 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg |
| SD 0.007 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg |
| SD 0.035 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg |
| SD 0.175 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg |
| SD 0.7 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg |
| SD 2.5 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg |
| SD 7.5 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg |
| SD Placebo | Experimental | Drug: placeboSubjects were injected once with placebo |
| MD 0.02 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg |
| MD 0.3 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg |
| MD 1.0 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg |
| MD 1.6 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg |
| MD 4.0 mg/kg | Experimental | Drug: NNC0142-0002Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg |
| MD Placebo | Experimental | Drug: placeboSubjects were injected biweekly four times with placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration
- Aged between 18 and 75 years (both inclusive)
- Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
- Use of highly effective contraception during the trial (both males and females)
Key exclusion criteria (8 listed)
- A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)
- An active or latent tuberculosis
- Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
- A known significant cardio-vascular disease
- Vaccination against live virus or bacteria within 4 weeks prior to randomization
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 |
|---|---|---|
| NNC0142-0002Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 | Drug | SD 0.0002 mg/kg |
| NNC0142-0002Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 | Drug | SD 0.0012 mg/kg |
| NNC0142-0002Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 | Drug | SD 0.007 mg/kg |
| NNC0142-0002Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 | Drug | SD 0.035 mg/kg |
| NNC0142-0002Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 | Drug | SD 0.175 mg/kg |
| NNC0142-0002Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 | Drug | SD 0.7 mg/kg |
| NNC0142-0002Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 | Drug | SD 2.5 mg/kg |
| NNC0142-0002Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1 | Drug | SD 7.5 mg/kg |
| placeboSingle dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times | Drug | SD Placebo |
| NNC0142-0002Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly | Drug | MD 0.02 mg/kg |
| NNC0142-0002Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly | Drug | MD 0.3 mg/kg |
| NNC0142-0002Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly | Drug | MD 1.0 mg/kg |
| NNC0142-0002Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly | Drug | MD 1.6 mg/kg |
| NNC0142-0002Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly | Drug | MD 4.0 mg/kg |
| placeboSingle dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times | Drug | MD Placebo |
Primary outcome
Frequency of Adverse Events
Time frame: Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.
Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.
1 secondary outcome
Area Under the Concentration-time Curve (AUC)
Time frame: Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Britta Væver Bysted, DVM, PhD 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 NNC0142-0002 in people with Inflammation and Rheumatoid Arthritis, run by Janssen Research & Development, LLC 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 4 inclusion and 8 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 3 Oct 2016. 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. 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?
Yes. Results are posted in the registry (first posted 21 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of Adverse Events (time frame: Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.). 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 3 Oct 2016.