InflammationPhase 1NCT01208506

First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis

A Phase 1 study testing NNC0114-0000-0005 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug), pharmacodynamic biomarkers (biomarkers related to anti-IL-21 expected mode of action) and signs of clinical efficacy of increasing single doses, at 9… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Inflammation, Rheumatoid Arthritis, Healthy
What is being tested?: NNC0114-0000-0005
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteGermany
Study dates: Sep 2010to Feb 2012
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

For all subjects the following applies:
Male subjects, if not sterilized, must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the trial corresponding to up to three months following trial drug administration. Male subjects must also agree to refrain from sperm donation from screening (trial start) until 120 days beyond trial drug administration
For healthy subjects (HS) the following additional criteria applies:
Male subjects, aged between 18 and 60 years (both inclusive) and in good health, as determined by past medical history, physical examination, vital signs, (electrocardiogram) ECG, and laboratory tests at screening (trial start)
For subjects with rheumatoid arthritis (RA) the following additional criteria applies:
Diagnosed with RA at least 3 months prior to trial drug administration

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Active RA, characterised by a Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) greater than 3.2
Effective methods of contraception
Male and female subjects aged greater and equal to 18 and greater and equal to 75 years
Females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year). If female of child-bearing potential must be willing to use highly effective method of birth control during the trial until their final visit
Methotrexate treatment (MTX) treatment for at least 12 weeks at a stable dose (dose at least 7.5 mg/week and maximum 25 mg/week inclusive) for at least 4 weeks prior to trial product administration
Concomitant medication according to specific list

Who cannot join

For all subjects the following applies:
Body mass index (BMI) between 20.0-38.0 kg/m2 (both inclusive)
Females with a positive pregnancy test
History of regular alcohol consumption exceeding 14 drinks per week for females or 21 drinks per week for men
Donation or loss of at least 400 mL of blood within 8 weeks prior to trial product administration
For healthy subjects (HS) the following additional criteria applies:

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Body weight greater than 110.0 kg
For subjects with rheumatoid arthritis (RA) the following additional criteria applies:
Chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)
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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Novo Nordisk Investigational Site
Berlin, 10117

Other trials in Germany

About this study

Official title: First Human Dose Trial of NNC0114-0000-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis

Conditions: Inflammation, Rheumatoid Arthritis, Healthy
Being tested: NNC0114-0000-0005, 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.

NNC0114-0000-0005Drug
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.
NNC0114-0000-0005Drug
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. In addition a single dose of NNC0114-0000-0005 administered s.c. (under the skin) in healthy subjects.
NNC0114-0000-0005Drug
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. In addition a single dose of NNC0114-0000-0005 may be administered s.c. (under the skin) in healthy subjects based on safety data.
NNC0114-0000-0005Drug
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. In addition a single dose of NNC0114-0000-0005 may be administered s.c. (under the skin) in healthy subjects based on safety data.
NNC0114-0000-0005Drug
A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA.
placeboDrug
A single dose of NNC0114-0000-0005 placebo.

Study groups in NCT01208506
Study group	Role	What they receive
Dose level 1	Experimental	Not described Receives: Drug: NNC0114-0000-0005; Drug: placebo
Dose level 2	Experimental	Not described Receives: Drug: NNC0114-0000-0005; Drug: placebo
Dose level 3	Experimental	Not described Receives: Drug: NNC0114-0000-0005; Drug: placebo
Dose level 4	Experimental	Not described Receives: Drug: NNC0114-0000-0005; Drug: placebo
Dose level 5	Experimental	Not described Receives: Drug: NNC0114-0000-0005; Drug: placebo
Dose level 6	Experimental	Not described Receives: Drug: NNC0114-0000-0005; Drug: placebo
Dose level 7	Experimental	Not described Receives: Drug: NNC0114-0000-0005; Drug: placebo
Dose level 8	Experimental	Not described Receives: Drug: NNC0114-0000-0005; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of adverse events
Measured: at least 12 weeks after dose administration

Secondary outcomes (3)

Area under the serum concentration-time curve
Measured: at least 12 weeks after dose administration
Maximum level of free IL-21 and maximum level of bound IL-21 in peripheral blood
Measured: at least 12 weeks after dose administration
Change in Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) in subjects with RA
Measured: at least 12 weeks after dose administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Feb 2012

First posted24 Sep 2010 (estimated)
Study startSep 2010
Primary completionFeb 2012
Study completionFeb 2012

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: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01208506
Sponsor's protocol ID: NN8828-3837
Other IDs: 2010-018347-33, U1111-1116-2585
Status last verified: Feb 2017
First submitted: 23 Sep 2010
Last updated: 8 Feb 2017
Results posted: No
Data monitoring committee: No

Publications

First in human study with recombinant anti-IL-21 monoclonal antibody in healthy subjects and patients with rheumatoid arthritis. Arthritis and Rheumatism 2012; 64 (10 (supplement)): Abstract 1279

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: First Human Dose Trial of NNC0114-0000-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01208506
Acronym / sponsor ID: NN8828-3837
Conditions: Inflammation, Rheumatoid Arthritis, Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 24 Sep 2010 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Dose level 1	Experimental	Drug: NNC0114-0000-0005, Drug: placebo
Dose level 2	Experimental	Drug: NNC0114-0000-0005, Drug: placebo
Dose level 3	Experimental	Drug: NNC0114-0000-0005, Drug: placebo
Dose level 4	Experimental	Drug: NNC0114-0000-0005, Drug: placebo
Dose level 5	Experimental	Drug: NNC0114-0000-0005, Drug: placebo
Dose level 6	Experimental	Drug: NNC0114-0000-0005, Drug: placebo
Dose level 7	Experimental	Drug: NNC0114-0000-0005, Drug: placebo
Dose level 8	Experimental	Drug: NNC0114-0000-0005, Drug: placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

For all subjects the following applies:
Male subjects, if not sterilized, must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the trial corresponding to up to three months following trial drug administration. Male subjects must also agree to refrain from sperm donation from screening (trial start) until 120 days beyond trial drug administration
For healthy subjects (HS) the following additional criteria applies:
Male subjects, aged between 18 and 60 years (both inclusive) and in good health, as determined by past medical history, physical examination, vital signs, (electrocardiogram) ECG, and laboratory tests at screening (trial start)
For subjects with rheumatoid arthritis (RA) the following additional criteria applies:

Key exclusion criteria (10 listed)

For all subjects the following applies:
Body mass index (BMI) between 20.0-38.0 kg/m2 (both inclusive)
Females with a positive pregnancy test
History of regular alcohol consumption exceeding 14 drinks per week for females or 21 drinks per week for men
Donation or loss of at least 400 mL of blood within 8 weeks prior to trial product administration

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
NNC0114-0000-0005A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.	Drug	Dose level 1, Dose level 2, Dose level 3, Dose level 7
NNC0114-0000-0005A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. In addition a single dose of NNC0114-0000-0005 administered s.c. (under the skin) in healthy subjects.	Drug	Dose level 4
NNC0114-0000-0005A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. In addition a single dose of NNC0114-0000-0005 may be administered s.c. (under the skin) in healthy subjects based on safety data.	Drug	Dose level 5
NNC0114-0000-0005A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. In addition a single dose of NNC0114-0000-0005 may be administered s.c. (under the skin) in healthy subjects based on safety data.	Drug	Dose level 6
NNC0114-0000-0005A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA.	Drug	Dose level 8
placeboA single dose of NNC0114-0000-0005 placebo.	Drug	Dose level 1, Dose level 2, Dose level 3, Dose level 4, Dose level 5, Dose level 6, Dose level 7, Dose level 8

Primary outcome

Incidence of adverse events
Time frame: at least 12 weeks after dose administration

3 secondary outcomes

Area under the serum concentration-time curve
Time frame: at least 12 weeks after dose administration
Maximum level of free IL-21 and maximum level of bound IL-21 in peripheral blood
Time frame: at least 12 weeks after dose administration
Change in Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) in subjects with RA
Time frame: at least 12 weeks after dose 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 8 Feb 2017.
Results publicationFirst in human study with recombinant anti-IL-21 monoclonal antibody in healthy subjects and patients with rheumatoid arthritis. Arthritis and Rheumatism 2012; 64 (10 (supplement)): Abstract 1279
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Active, not recruitingObservational study
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RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
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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 NNC0114-0000-0005 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 12 inclusion and 10 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 8 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. 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 (time frame: at least 12 weeks after dose administration). 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 NCT01208506, 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 8 Feb 2017.