InflammationPhase 1NCT01370902
Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis
A Phase 1 study testing NNC 0141-0000-0100 in people with Inflammation and Rheumatoid Arthritis, run by Innate Pharma at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of NNC141-0100 in subjects with… 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?
- NNC 0141-0000-0100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR1987 classification) of at least 3 months duration prior to randomisation
- Active Rheumatoid Arthritis (RA) characterised by a DAS28-CRP (Disease Activity Score of 28 joints, calculated with CRP (C-reactive protein) value) greater than or equal to 3.2
- Females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year) or be willing to use highly effective method of birth control
- Males must be willing to use highly effective contraception
- Subjects on stable doses of methotrexate (7.5 to 25 mg/week, both inclusive) for at least 4 weeks prior to randomisation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Single-dose and Multiple-dose, Dose-escalation Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis
This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of NNC141-0100 in subjects with Rheumatoid Arthritis.
- Conditions
- Inflammation, Rheumatoid Arthritis
- Being tested
- NNC 0141-0000-0100, 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.
NNC 0141-0000-0100Drug
Single dose administered subcutaneously (under the skin), up to six dose levels. Progression to next dose will be based on safety evaluation. Initiation of the MD s.c. phase will depend on the results from the SD i.v. cohorts as well as the first two dose cohorts of the SD s.c. part
placeboDrug
Single dose administered subcutaneously (under the skin) as a comparator at all dose levels
NNC 0141-0000-0100Drug
Multiple doses administered subcutaneously (under the skin) at 4 different occasions with a dosing interval of two weeks, at five different dose levels.
placeboDrug
Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels
NNC 0141-0000-0100Drug
Single dose administered intravenously (into a vein), up to nine dose levels. Progression to next dose will be based on safety evaluation. Initiation of the SD s.c. phase will depend on the results from the first three dose cohorts of the SD i.v. part
placeboDrug
Single dose administered intravenously (into a vein), as a comparator at all dose levels
| Study group | Role | What they receive |
|---|---|---|
| Single-dose (SD) trial part (i.v.) | Experimental | Not described Receives: Drug: NNC 0141-0000-0100; Drug: placebo |
| Single-dose (SD) trial part (s.c.) | Experimental | Not described Receives: Drug: NNC 0141-0000-0100; Drug: placebo |
| Multiple-dose (MD) trial part (s.c.) | Experimental | Not described Receives: Drug: NNC 0141-0000-0100; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: from trial product administration to week 12
Secondary outcomes (4)
Antibodies against NNC141-0100
Measured: from trial product administration until final visit (week 12 or longer if applicable)
Area under the serum concentration-time curve - SD trial part
Measured: from trial product administration until final visit (week 12 or longer if applicable)
Terminal half-life (t½) - SD trial part
Measured: from trial product administration until final visit (week 12 or longer if applicable)
Terminal half-life (t½) - MD trial part
Measured: from trial product administration until final visit (week 12 or longer if applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2014
- Study completionMar 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.
- 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innate Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renaud Buffet, Study director, Innate Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370902
- Sponsor's protocol ID
- NN8765-3658
- Other IDs
- 2010-019234-28, U1111-1120-2542
- Status last verified
- Dec 2014
- First submitted
- 31 May 2011
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Single-dose and Multiple-dose, Dose-escalation Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01370902
- Acronym / sponsor ID
- NN8765-3658
- Conditions
- Inflammation, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Innate PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Jun 2011 (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 dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of NNC141-0100 in subjects with Rheumatoid Arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single-dose (SD) trial part (i.v.) | Experimental | Drug: NNC 0141-0000-0100, Drug: placebo |
| Single-dose (SD) trial part (s.c.) | Experimental | Drug: NNC 0141-0000-0100, Drug: placebo |
| Multiple-dose (MD) trial part (s.c.) | Experimental | Drug: NNC 0141-0000-0100, Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR1987 classification) of at least 3 months duration prior to randomisation
- Active Rheumatoid Arthritis (RA) characterised by a DAS28-CRP (Disease Activity Score of 28 joints, calculated with CRP (C-reactive protein) value) greater than or equal to 3.2
- Females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year) or be willing to use highly effective method of birth control
- Males must be willing to use highly effective contraception
- Subjects on stable doses of methotrexate (7.5 to 25 mg/week, both inclusive) for at least 4 weeks prior to randomisation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NNC 0141-0000-0100Single dose administered subcutaneously (under the skin), up to six dose levels. Progression to next dose will be based on safety evaluation. Initiation of the MD s.c. phase will depend on the results from the SD i.v. cohorts as well as the first two dose cohorts of the SD s.c. part | Drug | Single-dose (SD) trial part (s.c.) |
| placeboSingle dose administered subcutaneously (under the skin) as a comparator at all dose levels | Drug | Single-dose (SD) trial part (s.c.) |
| NNC 0141-0000-0100Multiple doses administered subcutaneously (under the skin) at 4 different occasions with a dosing interval of two weeks, at five different dose levels. | Drug | Multiple-dose (MD) trial part (s.c.) |
| placeboMultiple doses administered subcutaneously (under the skin) as a comparator at all dose levels | Drug | Multiple-dose (MD) trial part (s.c.) |
| NNC 0141-0000-0100Single dose administered intravenously (into a vein), up to nine dose levels. Progression to next dose will be based on safety evaluation. Initiation of the SD s.c. phase will depend on the results from the first three dose cohorts of the SD i.v. part | Drug | Single-dose (SD) trial part (i.v.) |
| placeboSingle dose administered intravenously (into a vein), as a comparator at all dose levels | Drug | Single-dose (SD) trial part (i.v.) |
Primary outcome
Incidence of adverse events
Time frame: from trial product administration to week 12
4 secondary outcomes
Antibodies against NNC141-0100
Time frame: from trial product administration until final visit (week 12 or longer if applicable)
Area under the serum concentration-time curve - SD trial part
Time frame: from trial product administration until final visit (week 12 or longer if applicable)
Terminal half-life (t½) - SD trial part
Time frame: from trial product administration until final visit (week 12 or longer if applicable)
Terminal half-life (t½) - MD trial part
Time frame: from trial product administration until final visit (week 12 or longer if applicable)
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 23 Dec 2014.
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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.
Renaud Buffet study director
Innate Pharma
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 NNC 0141-0000-0100 in people with Inflammation and Rheumatoid Arthritis, run by Innate Pharma 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 5 inclusion and 0 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 23 Dec 2014. 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: from trial product administration to week 12). 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 23 Dec 2014.