Chronic Plaque-type PsoriasisPhase 1NCT01828086
Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis
A Phase 1 study testing CJM112 and Secukinumab in people with Chronic Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 18 sites in United States.
Trial summary
A randomized, double-blind, placebo and positive controlled, single and multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in chronic plaque-type psoriasis patients. This trial never made it to the Phase II part of this trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Plaque-type Psoriasis
- What is being tested?
- CJM112 and Secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 18 sitesUnited States
- Study dates
- Jun 2013to Oct 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women 18-65 years of age at time of consent
- Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
- At randomization, moderate to severe psoriasis as defined by:
- PASI score of 12 or greater and,
- IGA score of 3 or greater and,
- Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
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- Female patients may be included according to the following:
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, using highly effective methods of contraception during dosing and for 5 times the terminal half-life of study treatment.
- Male subjects must agree to comply with two highly effective contraceptive methods
Who cannot join
- Forms of psoriasis other than chronic plaque-type (incl. drug induced psoriasis)
- Ongoing use of prohibited psoriasis treatments and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
- Previous treatment with IL-17 or IL17R blocking agents, including secukinumab
- Any live vaccines (including nasal-spray flu vaccine) starting from 6 weeks before screening, during the study, and up to 24 weeks after the last dose of CJM112 or secukinumab
- Evidence of active tuberculosis at screening
- Active systemic infections (other than common cold)
- Pregnant or nursing (lactating) women
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Novartis Investigative Site
Anaheim, California, 92801
Novartis Investigative Site
Anniston, Alabama, 36207
Novartis Investigative Site
Austin, Texas, 78759
Novartis Investigative Site
Cincinnati, Ohio, 45255
Novartis Investigative Site
Crowley, Louisiana, 70526
Novartis Investigative Site
Encino, California, 91436
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Miami, Florida, 33136
Novartis Investigative Site
Miami, Florida, 33175
Novartis Investigative Site
Normal, Illinois, 61761
Novartis Investigative Site
North Hollywood, California, 91606
Novartis Investigative Site
Oklahoma City, Oklahoma, 73112
Novartis Investigative Site
Orlando, Florida, 32809
Novartis Investigative Site
Overland Park, Kansas, 66211
Novartis Investigative Site
Philadelphia, Pennsylvania, 19103
Novartis Investigative Site
Raleigh, North Carolina, 27612
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
Tampa, Florida, 33609
About this study
Official title: A Randomized, Double-blind, Placebo and Positive Controlled, Single and Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJM112 in Chronic Plaque-type Psoriasis Patients
A randomized, double-blind, placebo and positive controlled, single and multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in chronic plaque-type psoriasis patients. This trial never made it to the Phase II part of this trial.
- Conditions
- Chronic Plaque-type Psoriasis
- Being tested
- CJM112, Secukinumab, Placebo
- Keywords
- Psoriasis, chronic plaque-type psoriasis, IL17, monoclonal antibody
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJM112Biological
Monoclonal antibody
SecukinumabBiological
Also called AIN475
Monoclonal antibody
PlaceboOther
Liquid for subcutaneous injection without active drug.
| Study group | Role | What they receive |
|---|---|---|
| CJM112 | Experimental | CJM112 in different doses; single ascending and multiple ascending Receives: Biological: CJM112 |
| Placebo | Placebo comparator | Placebo to match Receives: Other: Placebo |
| Secukinumab | Active comparator | Active investigational drug. Receives: Biological: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety
Safety as assessed by the number of participants with adverse events as measured by laboratory parameters, vital signs, electrocardiogram and the collection of serious and non-serious adverse events.
Measured: 19 weeks
Secondary outcomes (3)
Psoriasis Area and Severity Index (PASI)
Measured: 19 weeks
Total CJM112 Concentrations in Serum
Measurement of drug levels in the blood of treated patients.
Measured: 19 weeks
Concentration of anti-CJM112 Antibodies in Serum
Assessment of the ability of the compound to evoke an immune response. Assessed in blood of treated patients.
Measured: 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Plaque-type PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828086
- Sponsor's protocol ID
- CCJM112X2101
- Status last verified
- Mar 2019
- First submitted
- 5 Apr 2013
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo and Positive Controlled, Single and Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJM112 in Chronic Plaque-type Psoriasis Patients
- ClinicalTrials.gov ID
- NCT01828086
- Acronym / sponsor ID
- CCJM112X2101
- Conditions
- Chronic Plaque-type Psoriasis
- Keywords
- Psoriasis, chronic plaque-type psoriasis, IL17, monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Apr 2013 (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.
A randomized, double-blind, placebo and positive controlled, single and multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in chronic plaque-type psoriasis patients. This trial never made it to the Phase II part of this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CJM112 | Experimental | Biological: CJM112CJM112 in different doses; single ascending and multiple ascending |
| Placebo | Placebo comparator | Other: PlaceboPlacebo to match |
| Secukinumab | Active comparator | Biological: SecukinumabActive investigational drug. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women 18-65 years of age at time of consent
- Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
- At randomization, moderate to severe psoriasis as defined by:
- PASI score of 12 or greater and,
- IGA score of 3 or greater and,
Key exclusion criteria (7 listed)
- Forms of psoriasis other than chronic plaque-type (incl. drug induced psoriasis)
- Ongoing use of prohibited psoriasis treatments and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
- Previous treatment with IL-17 or IL17R blocking agents, including secukinumab
- Any live vaccines (including nasal-spray flu vaccine) starting from 6 weeks before screening, during the study, and up to 24 weeks after the last dose of CJM112 or secukinumab
- Evidence of active tuberculosis at screening
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 |
|---|---|---|
| CJM112Monoclonal antibody | Biological | CJM112 |
| SecukinumabAlso: AIN475Monoclonal antibody | Biological | Secukinumab |
| PlaceboLiquid for subcutaneous injection without active drug. | Other | Placebo |
Primary outcome
Number of participants with adverse events as a measure of safety
Time frame: 19 weeks
Safety as assessed by the number of participants with adverse events as measured by laboratory parameters, vital signs, electrocardiogram and the collection of serious and non-serious adverse events.
3 secondary outcomes
Psoriasis Area and Severity Index (PASI)
Time frame: 19 weeks
Total CJM112 Concentrations in Serum
Time frame: 19 weeks
Concentration of anti-CJM112 Antibodies in Serum
Time frame: 19 weeks
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 11 Dec 2020.
- Results for CCJM112X2101 from the Novartis Trial Results databaseLink provided by the sponsor.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
18 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 CJM112 and Secukinumab in people with Chronic Plaque-type Psoriasis, run by Novartis Pharmaceuticals at 18 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 9 inclusion and 7 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 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 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?
Number of participants with adverse events as a measure of safety (time frame: 19 weeks). 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 11 Dec 2020.