InflammationPhase 1NCT00818064
Safety and Tolerability of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis
A Phase 1 study testing anti-IL-20 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 1 site in Netherlands.
Trial summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of single doses of Anti-IL-20 in healthy volunteers (HV) and patients with rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Rheumatoid Arthritis, Healthy
- What is being tested?
- anti-IL-20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2008to Jan 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For healthy volunteers (HV) the following applies:
- Subjects who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the Investigator
- Females who are post-menopausal, surgically sterile or of non-child-bearing potential
- For rheumatoid arthritis (RA) patients the following applies:
- A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least three months' duration prior to dosing
- Active RA, characterised by a Disease Activity Score 28 (DAS28) greater than 3.2
- Methotrexate treatment (stable doses of maximally 25.0 mg/week for at least 4 weeks) and concomitant intake of folic acid 1 mg/day or 5 mg/week
- Females who are post-menopausal, surgically sterile or of non-child-bearing potential
Who cannot join
- For healthy volunteers (HV) the following applies:
- Male subjects who do not accept to use double barrier methods of birth control from first dosing until 3 moths after their last visit
- Body mass index (BMI) below 18.5 or above 35.0 kg/m2
- Clinically significant cardiac or cardiovascular disease
- Abnormal blood pressure and heart rate
- Hepatic insufficiency
Show all 31Show fewer
- Renal insufficiency
- Positive for humane immunodeficiency virus (HIV)
- Positive for hepatitis B (HBV) or hepatitis C (HCV)
- Lymphoproliferative disease
- History or signs of malignancy (except adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to dosing)
- History of any autoimmune or current inflammatory conditions including rheumatoid arthritis or any other joint disease
- Active or latent tuberculosis: For tuberculosis unvaccinated subjects detected as a positive Mantoux test. For subjects vaccinated against tuberculosis detected as a positive QuantiFeron-test
- Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within the last 2 weeks prior to administration of trial drug
- Any vaccination within the last month before dosing
- Known active viral, bacterial or fungal infection, including herpes, herpes zoster or cold sores 14 days prior to dosing
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 2 weeks prior to dosing, unless in the opinion of the Investigator the medication will not interfere with the trial procedures or compromise the safety of the subject
- History of or current drug and/or alcohol abuse
- Blood donation within the last 3 months (more than 0.45 L)
- For rheumatoid arthritis (RA) patients the following applies:
- Male subjects who do not accept to use double barrier methods of birth control from first dosing until 3 months after their last visit
- Body mass index (BMI) below 18.5 or above 35.0 kg/m2
- Subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis (except secondary Sjögren's syndrome)
- History of or current inflammatory joint disease other than rheumatoid arthritis (e.g. gout, psoriatic or reactive arthritis, Lyme's disease, juvenile arthritis)
- Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within the last 2 weeks prior to dosing
- Any vaccination within the last month before dosing
- Known active viral, bacterial or fungal infection, including herpes, herpes zoster or cold sores 14 days prior to administration of trial product
- Lymphoproliferative disease
- History or signs of malignancy (except adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to dosing)
- Use of selective cyclooxygenase-2 (COX-2) inhibitors within the last 2 weeks prior to randomisation
- Concomitant medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Single- Dose, Dose-escalation Trial of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of single doses of Anti-IL-20 in healthy volunteers (HV) and patients with rheumatoid arthritis (RA).
- Conditions
- Inflammation, Rheumatoid Arthritis, Healthy
- Being tested
- anti-IL-20, 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.
anti-IL-20Drug
Also called NN8226
Single s.c. injection (per dose cohort)
placeboDrug
Also called NN8226
Single s.c. injection (per dose cohort)
| Study group | Role | What they receive |
|---|---|---|
| A, HV | Experimental | Dose cohort 1 (3 subjects active, 1 placebo) Receives: Drug: anti-IL-20; Drug: placebo |
| B, HV | Experimental | Dose cohort 2 (3 subjects active, 1 placebo) Receives: Drug: anti-IL-20; Drug: placebo |
| C, HV | Experimental | Dose cohort 3 (3 subjects active, 1 placebo) Receives: Drug: anti-IL-20; Drug: placebo |
| D, HV | Experimental | Dose cohort 4 (3 subjects active, 1 placebo) Receives: Drug: anti-IL-20; Drug: placebo |
| E, HV | Experimental | Dose cohort 5 (3 subjects active, 1 placebo) Receives: Drug: anti-IL-20; Drug: placebo |
| A, RA | Experimental | Dose cohort 1 (3 subjects active, 1 placebo) Receives: Drug: anti-IL-20; Drug: placebo |
| B, RA | Experimental | Dose cohort 2 (3 subjects active, 1 placebo) Receives: Drug: anti-IL-20; Drug: placebo |
| C, RA | Experimental | Dose cohort 3 (3 subjects active, 1 placebo) Receives: Drug: anti-IL-20; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, including injection site tolerability
Measured: during treatment
Secondary outcomes (5)
Terminal serum half-life (t½)
Measured: during treatment
Maximum observed serum concentration (Cmax)
Measured: during treatment
Time to reach maximum serum concentration (tmax)
Measured: during treatment
Area under the serum concentration-time curve (AUC0-t and AUC)
Measured: during treatment
Relevant biomarkers in serum and plasma, as well as synovial fluid (if applicable)
Measured: during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2010
- Study completionJan 2010
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 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
- 32 participants (estimated)
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
- NCT00818064
- Sponsor's protocol ID
- NN8226-3703
- Other IDs
- 2008-005529-13, EudraCT No: 2008-005529-13, 2008
- Status last verified
- Feb 2017
- First submitted
- 30 Dec 2008
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lundblad MS, Overgaard RV, Gothberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7.
PubMed 25749867
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Single- Dose, Dose-escalation Trial of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00818064
- Acronym / sponsor ID
- NN8226-3703
- Conditions
- Inflammation, Rheumatoid Arthritis, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Jan 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 Europe. The aim of this clinical trial is to investigate the safety and tolerability of single doses of Anti-IL-20 in healthy volunteers (HV) and patients with rheumatoid arthritis (RA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A, HV | Experimental | Drug: anti-IL-20, Drug: placeboDose cohort 1 (3 subjects active, 1 placebo) |
| B, HV | Experimental | Drug: anti-IL-20, Drug: placeboDose cohort 2 (3 subjects active, 1 placebo) |
| C, HV | Experimental | Drug: anti-IL-20, Drug: placeboDose cohort 3 (3 subjects active, 1 placebo) |
| D, HV | Experimental | Drug: anti-IL-20, Drug: placeboDose cohort 4 (3 subjects active, 1 placebo) |
| E, HV | Experimental | Drug: anti-IL-20, Drug: placeboDose cohort 5 (3 subjects active, 1 placebo) |
| A, RA | Experimental | Drug: anti-IL-20, Drug: placeboDose cohort 1 (3 subjects active, 1 placebo) |
| B, RA | Experimental | Drug: anti-IL-20, Drug: placeboDose cohort 2 (3 subjects active, 1 placebo) |
| C, RA | Experimental | Drug: anti-IL-20, Drug: placeboDose cohort 3 (3 subjects active, 1 placebo) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For healthy volunteers (HV) the following applies:
- Subjects who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the Investigator
- Females who are post-menopausal, surgically sterile or of non-child-bearing potential
- For rheumatoid arthritis (RA) patients the following applies:
- A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least three months' duration prior to dosing
Key exclusion criteria (31 listed)
- For healthy volunteers (HV) the following applies:
- Male subjects who do not accept to use double barrier methods of birth control from first dosing until 3 moths after their last visit
- Body mass index (BMI) below 18.5 or above 35.0 kg/m2
- Clinically significant cardiac or cardiovascular disease
- Abnormal blood pressure and heart rate
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 |
|---|---|---|
| anti-IL-20Also: NN8226Single s.c. injection (per dose cohort) | Drug | A, HV, A, RA, B, HV, B, RA, C, HV, C, RA, D, HV, E, HV |
| placeboAlso: NN8226Single s.c. injection (per dose cohort) | Drug | A, HV, A, RA, B, HV, B, RA, C, HV, C, RA, D, HV, E, HV |
Primary outcome
Adverse events, including injection site tolerability
Time frame: during treatment
5 secondary outcomes
Terminal serum half-life (t½)
Time frame: during treatment
Maximum observed serum concentration (Cmax)
Time frame: during treatment
Time to reach maximum serum concentration (tmax)
Time frame: during treatment
Area under the serum concentration-time curve (AUC0-t and AUC)
Time frame: during treatment
Relevant biomarkers in serum and plasma, as well as synovial fluid (if applicable)
Time frame: during treatment
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 9 Feb 2017.
- Results publication: PubMed 25749867Lundblad MS, Overgaard RV, Gothberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7.
- 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 anti-IL-20 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 1 site in Netherlands.
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 8 inclusion and 31 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 9 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 Netherlands. 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?
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?
Adverse events, including injection site tolerability (time frame: during treatment). 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 NCT00818064, 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 9 Feb 2017.