InflammationPhase 1NCT01261767
First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects
A Phase 1 study testing anti-IL-20 in people with Inflammation and Psoriasis, run by Novo Nordisk A/S at 16 sites in United States.
Trial summary
This trial is conducted in the United States of America (USA). The aim of this clinical trial is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to determine the preliminary efficacy in an expansion phase of this trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammation, Psoriasis
- 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
- 55 participants
- Where
- 16 sitesUnited States
- Study dates
- Apr 2008to Jan 2011
- 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
- Subjects with moderate to severe stable chronic plaque psoriasis for at least 6 months, with or without psoriatic arthritis
- Affected body surface area (BSA) greater than or equal to 15%
- Physician's Global Assessment (PGA) score of 3 or more
- Female subjects of non-childbearing potential or postmenopausal for at least 1 year. Male subjects must agree to use effective method of birth control
- Body Mass Index (BMI) less than or equal to 38.0 kg/m2
Who cannot join
- Concomitant anti-psoriatic treatment
- Infectious disease requiring systemic anti-infectious treatment within the 2 weeks prior to administration of trial drug
- Known history of Human Immunodeficiency Virus (HIV)
- Hepatitis B and/or C (determined by test)
- Live virus or bacteria vaccines within the last month before drug administration
- Known active herpes/herpes zoster/cold sores
Show all 10Show fewer
- Kidney insufficiency
- Liver insufficiency
- Lymphoproliferative disease
- History or signs of malignancy within the last 5 years
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Novo Nordisk Investigational Site
Baltimore, Maryland, 21225
Novo Nordisk Investigational Site
Birmingham, Alabama, 35294
Novo Nordisk Investigational Site
Boston, Massachusetts, 02111-1526
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46256-4697
Novo Nordisk Investigational Site
Los Angeles, California, 90036
Novo Nordisk Investigational Site
New Brunswick, New Jersey, 08903
Novo Nordisk Investigational Site
New York, New York, 10010
Novo Nordisk Investigational Site
New York, New York, 10029
Novo Nordisk Investigational Site
Norfolk, Virginia, 23507-1970
Novo Nordisk Investigational Site
Portland, Oregon, 97210-5102
Novo Nordisk Investigational Site
Portland, Oregon, 97239-4501
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84132-0002
Novo Nordisk Investigational Site
Skokie, Illinois, 60077
Novo Nordisk Investigational Site
St Louis, Missouri, 63117-1206
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Single and Multiple Dose, Dose-escalation Trial of Anti-IL-20 (109-0012) 100 mg/Vial in Psoriatic Subjects, Followed by an Expansion Phase
This trial is conducted in the United States of America (USA). The aim of this clinical trial is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to determine the preliminary efficacy in an expansion phase of this trial.
This trial consists of 3 parts: A single dose (SD) dose-escalation phase for 16 weeks, a multiple dose (MD) dose-escalation phase for 22 weeks, and a MD expansion phase for 22 weeks.
Initiation of the MD expansion phase will depend on results from the SD and MD dose-escalation phases and only if an acceptable safety profile is present. Subjects participating in the expansion phase are not allowed to have participated in the previous phases (SD and MD dose-escalation phases) of the trial.
- Conditions
- Inflammation, Psoriasis
- Being tested
- anti-IL-20, placebo
- Medical subject headings
- Inflammation, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-IL-20Drug
Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection
placeboDrug
Placebo for subcutaneous (under the skin) injection
| Study group | Role | What they receive |
|---|---|---|
| Anti-IL-20 | Experimental | Not described Receives: Drug: anti-IL-20 |
| 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.
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase
Measured: from week 0 until end of trial observation period at week 16
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD and MD expansion phases
Measured: from week 0 until end of trial observation period at week 22
Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase
Measured: at weeks 1-7, 9-15, 22
Secondary outcomes (6)
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD expansion phase
Measured: from week 0 until end of trial observation period at week 22
Improvement psoriasis area and severity index score by 75% (PASI75) - SD and MD phases
Measured: SD: at weeks 1, 3, 9, 13 and 16. MD: at weeks 1, 3, 5, 7, 9, 15, 22
Pharmacokinetics (the rate at which the body eliminates the trial drug) - SD and MD phases
Measured: SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7)
Pharmacokinetics (the rate at which the body eliminates the trial drug) - MD expansion phase
Measured: prior to dosing (week 1) and at each dosing visit (week 2-7)
Pharmacodynamics (the effect of the investigated drug on the body) - SD and MD phases
Measured: SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7)
Pharmacodynamics (the effect of the investigated drug on the body) - MD expansion phase
Measured: prior to dosing (week 1) and at each dosing visit (week 2-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startApr 2008
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Trial discontinued due to apparent lack of response in psoriasis measures. No safety concerns were present
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 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
- NCT01261767
- Sponsor's protocol ID
- NN8226-1848
- Other IDs
- U1111-1118-2792
- Status last verified
- Feb 2017
- First submitted
- 14 Dec 2010
- 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 25749867Gottlieb AB, Krueger JG, Sandberg Lundblad M, Gothberg M, Skolnick BE. First-In-Human, Phase 1, Randomized, Dose-Escalation Trial with Recombinant Anti-IL-20 Monoclonal Antibody in Patients with Psoriasis. PLoS One. 2015 Aug 7;10(8):e0134703. doi: 10.1371/journal.pone.0134703. eCollection 2015.
PubMed 26252485
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 and Multiple Dose, Dose-escalation Trial of Anti-IL-20 (109-0012) 100 mg/Vial in Psoriatic Subjects, Followed by an Expansion Phase
- ClinicalTrials.gov ID
- NCT01261767
- Acronym / sponsor ID
- NN8226-1848
- Conditions
- Inflammation, Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial discontinued due to apparent lack of response in psoriasis measures. No safety concerns were present
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Dec 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.
This trial is conducted in the United States of America (USA). The aim of this clinical trial is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to determine the preliminary efficacy in an expansion phase of this trial.
This trial consists of 3 parts: A single dose (SD) dose-escalation phase for 16 weeks, a multiple dose (MD) dose-escalation phase for 22 weeks, and a MD expansion phase for 22 weeks.
Initiation of the MD expansion phase will depend on results from the SD and MD dose-escalation phases and only if an acceptable safety profile is present. Subjects participating in the expansion phase are not allowed to have participated in the previous phases (SD and MD dose-escalation phases) of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-IL-20 | Experimental | Drug: anti-IL-20 |
| 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 (5 listed)
- Subjects with moderate to severe stable chronic plaque psoriasis for at least 6 months, with or without psoriatic arthritis
- Affected body surface area (BSA) greater than or equal to 15%
- Physician's Global Assessment (PGA) score of 3 or more
- Female subjects of non-childbearing potential or postmenopausal for at least 1 year. Male subjects must agree to use effective method of birth control
- Body Mass Index (BMI) less than or equal to 38.0 kg/m2
Key exclusion criteria (10 listed)
- Concomitant anti-psoriatic treatment
- Infectious disease requiring systemic anti-infectious treatment within the 2 weeks prior to administration of trial drug
- Known history of Human Immunodeficiency Virus (HIV)
- Hepatitis B and/or C (determined by test)
- Live virus or bacteria vaccines within the last month before drug 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 |
|---|---|---|
| anti-IL-20Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection | Drug | Anti-IL-20 |
| placeboPlacebo for subcutaneous (under the skin) injection | Drug | Placebo |
Primary outcome
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase
Time frame: from week 0 until end of trial observation period at week 16
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD and MD expansion phases
Time frame: from week 0 until end of trial observation period at week 22
Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase
Time frame: at weeks 1-7, 9-15, 22
6 secondary outcomes
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD expansion phase
Time frame: from week 0 until end of trial observation period at week 22
Improvement psoriasis area and severity index score by 75% (PASI75) - SD and MD phases
Time frame: SD: at weeks 1, 3, 9, 13 and 16. MD: at weeks 1, 3, 5, 7, 9, 15, 22
Pharmacokinetics (the rate at which the body eliminates the trial drug) - SD and MD phases
Time frame: SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7)
Pharmacokinetics (the rate at which the body eliminates the trial drug) - MD expansion phase
Time frame: prior to dosing (week 1) and at each dosing visit (week 2-7)
Pharmacodynamics (the effect of the investigated drug on the body) - SD and MD phases
Time frame: SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7)
Pharmacodynamics (the effect of the investigated drug on the body) - MD expansion phase
Time frame: prior to dosing (week 1) and at each dosing visit (week 2-7)
Results and safety
The study was stopped early (reason given: Trial discontinued due to apparent lack of response in psoriasis measures. No safety concerns were present). Results are not available in the source record.
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.
- Derived from this study: PubMed 26252485Gottlieb AB, Krueger JG, Sandberg Lundblad M, Gothberg M, Skolnick BE. First-In-Human, Phase 1, Randomized, Dose-Escalation Trial with Recombinant Anti-IL-20 Monoclonal Antibody in Patients with Psoriasis. PLoS One. 2015 Aug 7;10(8):e0134703. doi: 10.1371/journal.pone.0134703. eCollection 2015.
- 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
16 sites 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 Psoriasis, run by Novo Nordisk A/S at 16 sites in United States.
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 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: stopped early, 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 16 sites in United States. 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 was stopped early (reason given: Trial discontinued due to apparent lack of response in psoriasis measures. No safety concerns were present). Results are not available in the source record.
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?
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase (time frame: from week 0 until end of trial observation period at week 16). The study lists 3 primary outcomes in all. 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 NCT01261767, which also lists 2 linked publications.
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.