PsoriasisPhase 1NCT03337022
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CC-90006 in Subjects With Mild to Moderate Plaque-type Psoriasis
A Phase 1 study testing CC-90006 in people with Psoriasis, run by Celgene at 4 sites in 2 countries.
Trial summary
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and immunogenicity of CC-90006 following administration of multiple subcutaneous doses in subjects with mild to moderate plaque-type psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- CC-90006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 4 Jan 2018to 26 Apr 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The following is a summary of the inclusion criteria:
- Males or non-pregnant females between the ages of 18 and 60 years (inclusive) at the time of signing the ICF, and be willing to adhere to the requirements of contraception use throughout the study.
- Female subjects who claim to be surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingo-oophorectomy; proper documentation required) must have undergone the procedure at least 6 months before screening,
- Females who claim to be postmenopausal (defined as 24 consecutive months without menses before screening, should have a confirmed follicle-stimulating hormone [FSH] level of > 40 IU/L at screening).
- All other females must:
- Have two negative pregnancy tests (at screening and baseline) as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
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- Either commit to true abstinence from heterosexual contact or agree to use two forms of reliable contraception simultaneously. One must be a highly effective method and one additional effective (barrier) method, and both must be practiced without interruption, 28 days prior to starting investigational product, during the study therapy (including dose interruptions), and for 4 months after discontinuation of study therapy.
- Males must practice true abstinence1 (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural [animal] membrane [latex condoms are recommended]) during sexual contact with a pregnant female or FCBP2 while participating in the study, during dose interruptions, and for at least 4 months after the last dose of IP, even if he has undergone a successful vasectomy.
- Must be diagnosed with mild to moderate plaque-type psoriasis at least 6 months prior to baseline (Day 1).
- Must have a PASI ≤ 15 at screening and baseline (Day 1).
- Must have a body surface area affected score (BSA) ≥ 1 and sPGA ≥ 3 at screening and baseline (Day 1).
- Must have at least two plaques, at least 3 x 3 centimeters(cm) in diameter. One plaque will be used for punch biopsy and the other for TPSS evaluation.
- Other than the diagnosed condition of mild to moderate plaque-type psoriasis, the subject must be in good health as determined by a physical examination (PE) at screening.
- Has a body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 at screening.
- For all other clinical laboratory safety test parameters, the subject has results within normal limits or judged to be not clinically significant by the Investigator.
Who cannot join
- The following is a summary of the exclusion criteria:
- Presence of any significant medical condition, laboratory abnormality, or psychiatric illness which places him or her at unacceptable risk by participating in the study, or that would that would prevent the subject from participating in the study for other reasons, or would confound the ability to interpret data from the study.
- History of cancer.
- Presence of cancer or pre-cancerous conditions,
- Presence of confirmed cervical dysplasia.
- Presence of a systemic infection or any potentially opportunistic infections (eg, atypical mycobacterial, CMV, Clostridium difficile, multifocal herpetic, etc).
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- (Immunologic disorders such as rheumatoid arthritis, lupus, asthma, and any immunodeficiency are exclusionary.)
- Presence of latent tuberculosis infection and/or active tuberculosis disease, as tested using QuantiFERON-TB Gold test (or equivalent). Subjects with a history of TB who have completed treatment (documented) may be eligible for the study.
- History of serum hepatitis, or a confirmed carrier of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcA), or hepatitis C virus antibody (HCV Ab), or who has a positive HIV antibody test.
- Presence of non-plaque psoriasis (erythrodermic, guttate, inverse, or pustular psoriasis).
- Presence of dermatological diseases other than plaque psoriasis, including but not limited to seborrheic dermatitis, lichen simplex chronicus, atopic dermatitis, nummular eczema, superficial fungal infections, subacute cutaneous lupus erythematosus, pityriasis rubra pilaris, crusted scabies, cutaneous T cell lymphoma
- Use of topical therapy for psoriasis within 14 days of first dosing (including but not limited to corticosteroids, retinoids, vitamin D analog, calcineurin inhibitors, salicylic acid).
- Use of systemic therapy for psoriasis within 30 days of first dose administration.
- Use of phototherapy for psoriasis within 30 days of first dose administration.
- Use of systemic biologics treatment for psoriasis within 24 weeks of first dose administration.
- Exposure to an immunosuppressive or immunomodulatory drug within 30 days of first dose administration, or five half-lives of the drug (whichever is longer).
- Exposure to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or five half-lives of that investigational drug, if known (whichever is longer).
- Smoking > 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).
- Vaccination within 30 days prior to the first dose administration or subject has plans to receive a vaccination during the course of the study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
TKL Research
Fair Lawn, New Jersey, 07410
About this study
Official title: A Phase 1, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 Administered Subcutaneously in Patients With Plaque-type Psoriasis
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and immunogenicity of CC-90006 following administration of multiple subcutaneous doses in subjects with mild to moderate plaque-type psoriasis.
Read the detailed description
The study will be conducted in subjects with mild to moderate plaque-type psoriasis.
The study will consist of escalating multiple (three) doses in sequential groups. Approximately 40 subjects with plaque-type psoriasis will be enrolled into approximately 4 planned dose cohorts.
Each cohort will study a different CC-90006 dose level and have ten subjects; eight subjects will receive CC-90006 and two subjects will receive placebo. Subjects will be dosed according to a computer-generated randomization scheme. Dosing will occur on Days 1, 15 (Week 2), and 29 (Week 4). During the study, blood samples and punch biopsies will be collected to determine the amount of CC-90006 in the body and to evaluate its effect on the subject's condition. Subjects will return to the clinic for regular follow up visits for safety, PK, and PD. A follow up phone call to each subject to determine general health will occur on Day 141 (week 20).
- Conditions
- Psoriasis
- Being tested
- CC-90006, Placebo
- Keywords
- Psoriasis, CC-90006, Mild to moderate plaque-type psoriasis, Safety, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-90006Drug
CC-90006
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CC-90006; Dose level 1 | Experimental | CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29. Receives: Drug: CC-90006 |
| CC-90006; Dose level 2 | Experimental | CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29. Receives: Drug: CC-90006 |
| CC-90006; Dose level 3 | Experimental | CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29. Receives: Drug: CC-90006 |
| CC-90006; Dose level 4 | Experimental | CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29. Receives: Drug: CC-90006 |
| Placebo | Placebo comparator | Placebo (saline) will be administered subcutaneously (SC) on days 1, 15, and 29. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Number of participants with adverse events
Measured: Up to approximately Week 20
Secondary outcomes (9)
Pharmacokinetics: Cmax
Observed maximum concentration of CC-90006 in serum
Measured: Up to approximately 16 weeks
Pharmacokinetics - Tmax
Time to reach the observed maximum concentration of CC-90006 in serum
Measured: Up to approximately 16 weeks
Pharmacokinetics - AUC 0-t
Area under that serum-concentration time curve calculated from time zero to the last measured time point
Measured: Up to approximately 16 weeks
Pharmacokinetics - AUC 0-∞
Area under that serum-concentration time curve calculated from time zero to ∞
Measured: Up to approximately 16 weeks
Pharmacokinetics - t1/2
Terminal elimination half-life
Measured: Up to approximately 16 weeks
Pharmacokinetics - CL/F
Apparent clearance of drug from serum after extravascular administration
Measured: Up to approximately 16 weeks
Pharmacokinetics - Vz/F
Apparent volume of distribution during the terminal phase
Measured: Up to approximately 16 weeks
Pharmacokinetics - Rac [AUCτ]
Accumulation ratio based on Cmax (Rac [Cmax]) and AUCτ
Measured: Up to approximately 16 weeks
Fraction of subjects with Anti-drug antibody (ADA)
Measure of the body's immune response to CC-90006
Measured: Up to approximately 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start4 Jan 2018
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
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.
- More trials run by CelgeneThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leon Carayannopoulos, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337022
- Sponsor's protocol ID
- CC-90006-CP-002
- Status last verified
- May 2020
- First submitted
- 7 Nov 2017
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 Administered Subcutaneously in Patients With Plaque-type Psoriasis
- ClinicalTrials.gov ID
- NCT03337022
- Acronym / sponsor ID
- CC-90006-CP-002
- Conditions
- Psoriasis
- Keywords
- Psoriasis, CC-90006, Mild to moderate plaque-type psoriasis, Safety, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 8 Nov 2017 (actual)
- 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 is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and immunogenicity of CC-90006 following administration of multiple subcutaneous doses in subjects with mild to moderate plaque-type psoriasis.
Detailed description
The study will be conducted in subjects with mild to moderate plaque-type psoriasis.
The study will consist of escalating multiple (three) doses in sequential groups. Approximately 40 subjects with plaque-type psoriasis will be enrolled into approximately 4 planned dose cohorts.
Each cohort will study a different CC-90006 dose level and have ten subjects; eight subjects will receive CC-90006 and two subjects will receive placebo. Subjects will be dosed according to a computer-generated randomization scheme. Dosing will occur on Days 1, 15 (Week 2), and 29 (Week 4). During the study, blood samples and punch biopsies will be collected to determine the amount of CC-90006 in the body and to evaluate its effect on the subject's condition. Subjects will return to the clinic for regular follow up visits for safety, PK, and PD. A follow up phone call to each subject to determine general health will occur on Day 141 (week 20).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CC-90006; Dose level 1 | Experimental | Drug: CC-90006CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29. |
| CC-90006; Dose level 2 | Experimental | Drug: CC-90006CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29. |
| CC-90006; Dose level 3 | Experimental | Drug: CC-90006CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29. |
| CC-90006; Dose level 4 | Experimental | Drug: CC-90006CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (saline) will be administered subcutaneously (SC) on days 1, 15, and 29. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Males or non-pregnant females between the ages of 18 and 60 years (inclusive) at the time of signing the ICF, and be willing to adhere to the requirements of contraception use throughout the study.
- Must be diagnosed with mild to moderate plaque-type psoriasis at least 6 months prior to baseline (Day 1).
- Must have a PASI ≤ 15 at screening and baseline (Day 1).
- Must have a body surface area affected score (BSA) ≥ 1 and sPGA ≥ 3 at screening and baseline (Day 1).
- Must have at least two plaques, at least 3 x 3 centimeters(cm) in diameter. One plaque will be used for punch biopsy and the other for TPSS evaluation.
Key exclusion criteria (19 listed)
- Presence of any significant medical condition, laboratory abnormality, or psychiatric illness which places him or her at unacceptable risk by participating in the study, or that would that would prevent the subject from participating in the study for other reasons, or would confound the ability to interpret data from the study.
- History of cancer.
- Presence of cancer or pre-cancerous conditions,
- Presence of confirmed cervical dysplasia.
- Presence of a systemic infection or any potentially opportunistic infections (eg, atypical mycobacterial, CMV, Clostridium difficile, multifocal herpetic, etc).
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 |
|---|---|---|
| CC-90006CC-90006 | Drug | CC-90006; Dose level 1, CC-90006; Dose level 2, CC-90006; Dose level 3, CC-90006; Dose level 4 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Adverse Events (AEs)
Time frame: Up to approximately Week 20
Number of participants with adverse events
9 secondary outcomes
Pharmacokinetics: Cmax
Time frame: Up to approximately 16 weeks
Pharmacokinetics - Tmax
Time frame: Up to approximately 16 weeks
Pharmacokinetics - AUC 0-t
Time frame: Up to approximately 16 weeks
Pharmacokinetics - AUC 0-∞
Time frame: Up to approximately 16 weeks
Pharmacokinetics - t1/2
Time frame: Up to approximately 16 weeks
Pharmacokinetics - CL/F
Time frame: Up to approximately 16 weeks
Pharmacokinetics - Vz/F
Time frame: Up to approximately 16 weeks
Pharmacokinetics - Rac [AUCτ]
Time frame: Up to approximately 16 weeks
Fraction of subjects with Anti-drug antibody (ADA)
Time frame: Up to approximately 16 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 7 May 2020.
- 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.
Leon Carayannopoulos, MD study director
Celgene Corporation
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-90006 in people with Psoriasis, run by Celgene at 4 sites in 2 countries.
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 15 inclusion and 19 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
Adverse Events (AEs) (time frame: Up to approximately Week 20). 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 7 May 2020.