PsoriasisPhase 1NCT00925574
A Study of the Safety and How the Body Affects a Drug (CNTO 1959) in Healthy Volunteers and in Patients With Psoriasis
A Phase 1 study of Psoriasis, run by Centocor, Inc. at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and how the body affects a drug (CNTO 1959) in healthy volunteers and in patients with psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 Jun 2009to 11 Oct 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female with no clinically significant abnormalities and have a body weight of 50 to 100 kg (Enrollment of healthy volunteers closed on 23SEP09)
- Patients with moderate to severe psoriasis and have a body weight not greater than 120 kg.
Who cannot join
- Current or a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the patient, including (but not limited to) cardiovascular disease, neuromuscular, hematological disease, respiratory disease, hepatic or GI disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- Known or recent history of alcohol or drug abuse
- Major or traumatic surgery within 12 weeks of screening
- Donated blood greater than 500 ml within 56 days of screening
- Pregnant or nursing
- Have recently received phototherapy or any systemic medications/treatments that could affect psoriasis
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Baltimore, Maryland
Study site
Los Angeles, California
Study site
Miramar, Florida
Study site
New York, New York
Study site
Overland Park, Kansas
Study site
Portland, Oregon
Study site
San Diego, California
Study site
St Louis, Missouri
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 Following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects and in Subjects With Moderate to Severe Psoriasis
The purpose of this study is to evaluate the safety and how the body affects a drug (CNTO 1959) in healthy volunteers and in patients with psoriasis.
Read the detailed description
CNTO 1959 is an experimental drug. In this study, CNTO 1959 will be tested to see if it may be useful in treating psoriasis. This disease causes inflammation of skin and nails. This is a Randomized (study drug assigned by chance), Double-blind (neither physician nor patient knows the name of the assigned drug), Placebo-controlled study of the experimental drug CNTO 1959 in both healthy patients as well as patients with psoriasis. This study will compare the effects (both good and bad) of CNTO 1959 to those of placebo. The purpose of this study is to evaluate the safety and potential side effects of CNTO 1959 given to healthy volunteers and patients with moderate to severe psoriasis. In addition, the investigators will measure how much study drug is in the blood following a dose of CNTO 1959, and determine if the body makes antibodies to it. (An antibody is a protein made by the body in response to a foreign substance). Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. This is the first time that CNTO 1959 will be studied in humans. There will be 2 parts to this study. The first part of this study will involve healthy volunteers, and the second part of the study will involve patients with psoriasis. About 47 healthy volunteers and 24 patients with moderate to severe psoriasis will take part in the study. Enrollment for the healthy volunteer part is closed as of 23SEP09. CNTO 1959 will be administered as either an intravenous (IV) infusion or subcutaneous (SC) injection. Duration of participation may be up to 28 weeks.
- Conditions
- Psoriasis
- Being tested
- CNTO 1959; Placebo
- Keywords
- CNTO 1959, Healthy Volunteers, Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 1959; PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of CNTO 1959 in healthy volunteers and patients with psoriasis.
Measured: Assessments will occur at each study visit and up to 24 weeks following administration of study agent
Secondary outcomes (4)
Pharmacokinetics.
Measured: Assessments will occur at study visits through 24 weeks following administration of study agent.
Pharmacodynamics
Measured: Assessments will occur at study visits through 24 weeks following administration of study agent.
Immune Response
Measured: Assessments will occur at study visits through 24 weeks following administration of study agent.
Clinical Response
Measured: Assessments will occur at study visits through 24 weeks following administration of study agent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study start4 Jun 2009
- Primary completion11 Oct 2010
- Study completion11 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Single group
- Masking
- Double blind
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925574
- Sponsor's protocol ID
- CR015817
- Other IDs
- CNTO1959PSO1001, CR015817
- Status last verified
- Aug 2017
- First submitted
- 16 Jun 2009
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 Following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects and in Subjects With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT00925574
- Acronym / sponsor ID
- CR015817
- Conditions
- Psoriasis
- Keywords
- CNTO 1959, Healthy Volunteers, Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2009 (actual)
- Primary completion
- 11 Oct 2010 (actual)
- Study completion
- 11 Oct 2010 (actual)
- First posted
- 22 Jun 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.
The purpose of this study is to evaluate the safety and how the body affects a drug (CNTO 1959) in healthy volunteers and in patients with psoriasis.
Detailed description
CNTO 1959 is an experimental drug. In this study, CNTO 1959 will be tested to see if it may be useful in treating psoriasis. This disease causes inflammation of skin and nails. This is a Randomized (study drug assigned by chance), Double-blind (neither physician nor patient knows the name of the assigned drug), Placebo-controlled study of the experimental drug CNTO 1959 in both healthy patients as well as patients with psoriasis. This study will compare the effects (both good and bad) of CNTO 1959 to those of placebo. The purpose of this study is to evaluate the safety and potential side effects of CNTO 1959 given to healthy volunteers and patients with moderate to severe psoriasis. In addition, the investigators will measure how much study drug is in the blood following a dose of CNTO 1959, and determine if the body makes antibodies to it. (An antibody is a protein made by the body in response to a foreign substance). Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. This is the first time that CNTO 1959 will be studied in humans. There will be 2 parts to this study. The first part of this study will involve healthy volunteers, and the second part of the study will involve patients with psoriasis. About 47 healthy volunteers and 24 patients with moderate to severe psoriasis will take part in the study. Enrollment for the healthy volunteer part is closed as of 23SEP09. CNTO 1959 will be administered as either an intravenous (IV) infusion or subcutaneous (SC) injection. Duration of participation may be up to 28 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male or female with no clinically significant abnormalities and have a body weight of 50 to 100 kg (Enrollment of healthy volunteers closed on 23SEP09)
- Patients with moderate to severe psoriasis and have a body weight not greater than 120 kg.
Key exclusion criteria (6 listed)
- Current or a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the patient, including (but not limited to) cardiovascular disease, neuromuscular, hematological disease, respiratory disease, hepatic or GI disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- Known or recent history of alcohol or drug abuse
- Major or traumatic surgery within 12 weeks of screening
- Donated blood greater than 500 ml within 56 days of screening
- Pregnant or nursing
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 |
|---|---|---|
| CNTO 1959; Placebo | Drug | – |
Primary outcome
Safety and tolerability of CNTO 1959 in healthy volunteers and patients with psoriasis.
Time frame: Assessments will occur at each study visit and up to 24 weeks following administration of study agent
4 secondary outcomes
Pharmacokinetics.
Time frame: Assessments will occur at study visits through 24 weeks following administration of study agent.
Pharmacodynamics
Time frame: Assessments will occur at study visits through 24 weeks following administration of study agent.
Immune Response
Time frame: Assessments will occur at study visits through 24 weeks following administration of study agent.
Clinical Response
Time frame: Assessments will occur at study visits through 24 weeks following administration of study agent.
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 5 Sep 2017.
- Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects and in Subjects with Moderate to Severe PsoriasisLink 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.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Psoriasis, run by Centocor, Inc. at 8 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 2 inclusion and 6 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 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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?
Safety and tolerability of CNTO 1959 in healthy volunteers and patients with psoriasis. (time frame: Assessments will occur at each study visit and up to 24 weeks following administration of study agent). 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 5 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.