ParapsoriasisPhase 1NCT02502188
Phase 1 Study of CC-90005 in Healthy Subjects and Subjects With Moderate to Severe Plaque-type Psoriasis
A Phase 1 study testing CC-90005 in people with Parapsoriasis and Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
To evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of CC-90005 in healthy subjects and subjects with moderate to severe plaque-type psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parapsoriasis, Healthy Volunteers
- What is being tested?
- CC-90005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2015to 2 Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1 (Healthy Subjects)
- Subjects must satisfy the following criteria to be enrolled in the study:
- Female or male subject is ≥ 18 and ≤ 65 years of age at the time of signing the informed consent form (ICF).
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject is in good health as determined by a physical examination at screening.
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- Female subjects of childbearing potential (FCBP) 1 must:
- Have two negative pregnancy tests as verified by the Investigator prior to the first dose of Investigational Product (IP). She must agree to ongoing pregnancy testing during the course of the study, and prior to discharge from the clinical site. This applies even if the FCBP subject practices true abstinence from heterosexual contact.
- Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective contraception without interruption, during the study (including dose interruptions) and for at least 28 days after discontinuation of IP.
- The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).
- Female subjects NOT of childbearing potential must:
- Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone [FSH] level of > 40 IU/L at screening)
- Male subjects must:
- Practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to use a condom during sexual contact with a pregnant female or FCBP while participating in the study, during dose interruptions and for at least 28 days after discontinuation of IP, even if he has undergone a successful vasectomy.
- Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
- Subject has platelet count, absolute neutrophil count, and absolute lymphocyte count above the lower limit of normal at screening.
- Subject has liver function tests below the upper limit of normal at screening.
- For all other clinical laboratory safety test parameters, the subject has results within normal limits or acceptable to the Investigator.
- Subject is afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg, supine diastolic BP ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 110 bpm at screening.
- Subject has a normal or clinically-acceptable 12-lead ECG at screening. In addition:
- If male, subject has a QTcF value ≤ 430 msec at screening.
- If female, subject has a QTcF value ≤ 450 msec at screening.
- Part 2 (Subjects with Moderate to Severe Plaque-type Psoriasis)
- Subjects must satisfy the following criteria to be enrolled in the study:
- Female or male subject is ≥ 18 and ≤ 70 years of age at the time of signing the ICF.
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject is generally healthy, with the exception of the underlying psoriasis, as determined by medical history review, physical examination, 12-lead ECG, clinical chemistry, hematology, and urinalysis at screening.
- Subject has a clinical diagnosis of stable moderate to severe plaque-type psoriasis at least 6 months prior to screening, defined as:
- PASI score ≥ 12;
- BSA ≥ 10%; and
- sPGA score ≥ 3.
- FCBP must:
- Have two negative pregnancy tests as verified by the Investigator prior to the first dose of IP. She must agree to ongoing pregnancy testing during the course of the study, and prior to discharge from the clinical site. This applies even if the FCBP subject practices true abstinence from heterosexual contact.
- Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective contraception without interruption, during the study (including dose interruptions) and for at least 28 days after discontinuation of IP.
- The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).
- Female subjects NOT of childbearing potential must:
- Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a FSH level of > 40 IU/L at screening)
- Male subjects must:
- Practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to use a condom during sexual contact with a pregnant female or FCBP while participating in the study, during dose interruptions and for at least 28 days after discontinuation of IP, even if he has undergone a successful vasectomy.
- Subject is a candidate for photo/systemic therapy. A subject is considered a candidate for photo/systemic therapy if, in the judgment of the Investigator, the subject requires any ultraviolet (UV) radiation or systemic therapy (eg, ultraviolet light B [UVB], psoralens and long-wave ultraviolet radiation [PUVA], methotrexate, cyclosporine, corticosteroids, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, or approved biological agent) to control psoriasis, whether or not the subject has a history of receiving systemic therapy.
- Subject has an antitetanus immunoglobulin (Ig) G titer ≥ 0.15 IU/mL to ensure prior exposure of tetanus toxoid (Bingham, 2010).
Who cannot join
- Part 1 (Healthy Subjects)
- The presence of any of the following will exclude a subject from enrollment:
- Subject has any significant and relevant medical condition (including but not limited to neurological, gastrointestinal (GI), renal, hepatic, CV, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject is pregnant or breastfeeding.
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- Subject was exposed 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).
- Subject has used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days prior to the first dose administration.
- Subject has used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days prior to the first dose administration.
- Subject has used CYP3A inducers and/or inhibitors (including St. John's wort) within 30 days prior to the first dose administration. The Indiana University "Cytochrome P450 Drug Interaction Table" should be utilized to determine inhibitors and/or inducers of CYP3A (http://medicine.iupui.edu/clinpharm/ddis/table.aspx).
- Subject has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion, eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable.
- Subject donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
- Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before the first dose administration, or positive drug screening test reflecting consumption of illicit drugs.
- Subject has a history of alcohol abuse (as defined by the current version of the DSM) within 2 years before the first dose administration, or positive alcohol screen.
- Subject is known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening.
- Subject smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).
- Subject had systemic infection within 30 days prior to the first dose administration.
- Subject has a previous history of autoimmune disease.
- Subject is part of the clinical staff personnel or a family member of the clinical site staff.
- Part 2 (Subjects with Moderate to Severe Plaque-type Psoriasis)
- The presence of any of the following will exclude a subject from enrollment:
- Subject has any significant and relevant medical condition (including but not limited to neurological, GI, renal, hepatic, CV, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major uncontrolled disease), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject is pregnant or breastfeeding.
- Subject has known active, current or history of recurrence of bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease, and herpes zoster), HIV, or any major episode of infection requiring hospitalization or treatment with intravenous or oral antibiotics within 4 weeks prior to screening.
- Subject completed treatment for mycobacterial infection (ie, TB) at least 3 years prior to screening but lacks documentation.
- Subject has a positive QuantiFERON-Gold test or two successive indeterminate QuantiFERON-Gold tests at screening. Subjects with a history of TB who have undergone treatment (documented) may be eligible for study entry.
- Subject has a history of incompletely treated Mycobacterium tuberculosis infection, as indicated by:
- Subject's medical records documenting incomplete treatment for Mycobacterium tuberculosis.
- Subject's self-reported history of incomplete treatment for Mycobacterium tuberculosis.
- Subject has any clinically significant findings/abnormalities on chest X-ray at screening.
- Subject is known to have serum hepatitis or known to be a carrier of HBsAg or HCV Ab, or have a positive result to the test for HIV antibodies at screening.
- Subject has a history of positive congenital and acquired immunodeficiencies (eg, Common Variable Immunodeficiency [CVID]).
- Subject has a history of solid tumors and hematologic malignancies. Note: Subjects with a history of squamous or basal cell carcinoma of the skin or cervical intraepithelial neoplasia (CIN) or in situ cervical carcinoma that has been excised and cured > 5 years from screening are eligible for study entry.
- Subject has psoriasis flare within 4 weeks before screening, defined as a sudden intensification of psoriasis requiring prescribed medical intervention or a diagnosis of erythrodermic, guttate, or pustular psoriasis.
- Subject has evidence of skin conditions that would interfere with evaluations related to the effect of IP on psoriasis.
- Subject received topical therapy within 14 days prior to the first dose administration (including but not limited to topical corticosteroids, topical retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin). Exceptions: low potency corticosteroids will be allowed as background therapy for treatment of the face, axillae and groin in accordance with the manufacturers' suggested usage during the course of the study. Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. Eucerin® cream (the standard emollient for this study) will also be permitted for body lesions only. Subjects must not use these treatments within 24 hours prior to each check-in.
- Subject received systemic therapy for psoriasis within 4 weeks prior to the first dose administration (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, fumaric acid esters, and apremilast).
- Subject used phototherapy (eg, UVB, PUVA) within 4 weeks prior to the first dose administration.
- Subject used adalimumab, etanercept, efalizumab or infliximab within 12 weeks prior to the first dose administration.
- Subject used alefacept omalizumab, rituximab, ustekinumab, briakinumab, or other therapeutic antibody products within 24 weeks prior to the first dose administration.
- Subject was exposed 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).
- Subject has a history of alcohol, drug or chemical abuse within 6 months prior to screening.
- Subject had a major surgery within 8 weeks prior to screening and/or planned major surgery during the entire length of the study.
- Subject has prolonged sun exposure or uses tanning booths or other UV light sources.
- Subject received tetanus vaccination within 5 years prior to the first dose administration.
- Subject self-reports a history of hypersensitivity to any component of TENIVAC® or any other tetanus or diphtheria toxoid-containing vaccine, including hypersensitivity to latex.
- Subject self-reports any previous unacceptable adverse reaction, ie, extreme hypersensitivity or allergy, to Candida albicans antigen or to a similar product, immunization, or shellfish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Multicenter, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CC-90005 in Healthy Subjects and Subjects With Moderate to Severe Plaque-type Psoriasis
To evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of CC-90005 in healthy subjects and subjects with moderate to severe plaque-type psoriasis.
Read the detailed description
This is a 2-part study to be conducted at multiple study centers. Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90005 following a single oral dose in healthy subjects. During the course of Part 1, each subject will participate in a screening phase, baseline phase(s), treatment phase(s) and a follow up visit. There will be a total of 3 planned cohorts, each of which will consist of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC 90005 and 2 subjects will receive placebo depending on the randomization schedule. Each cohort will receive a minimum of 2 doses, with one of the cohorts receiving a third dose (up to three study periods per cohort). Administration of study drug at the next higher dose level will not begin until the safety and tolerability of the preceding dose have been evaluated and deemed acceptable by the investigator and sponsor's medical monitor. Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90005 following multiple oral doses in subjects with moderate to severe plaque-type psoriasis. During the course of Part 2, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow up visit. There will be a total of 4 planned cohorts, each of which will consist of a different dose level, with 12 subjects per cohort. In each cohort, 9 subjects will receive a dose of CC-90005 and 3 subjects will receive placebo depending on the randomization schedule. It is planned for study drug to be administered twice daily for 28 days. Proposed dose levels in Part 2 may be modified and/or eliminated based on data obtained from Part 1 and/or from previous data obtained in Part 2.
- Conditions
- Parapsoriasis, Healthy Volunteers
- Being tested
- CC-90005, Placebo
- Keywords
- Healthy Subjects, Severe Plaque Psoriasis, Moderate, Phase 1, Safety, Tolerability, CC-90005
- Medical subject headings
- Parapsoriasis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-90005Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - CC-90005 and Placebo | Experimental | CC-90005 or Placebo will be administered orally from low to high dose Receives: Drug: CC-90005; Drug: Placebo |
| Part 2 - CC-90005 and Placebo | Experimental | CC-90005 or Placebo will be administered orally from low to high dose Receives: Drug: CC-90005; Drug: 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 12 months
Secondary outcomes (15)
Pharmacokinetics- Cmax
Maximum observed plasma concentration
Measured: Up to 28
Pharmacokinetics- Tmax
Time to Cmax (Maximum observed plasma concentration)
Measured: Up to 28
Pharmacokinetics- AUC∞
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Measured: Up to 28 days
Pharmacokinetics- AUCt
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Measured: Up to 28 days
Pharmacokinetics- AUC24
Area under the plasma concentration-time curve from time zero to 24 hours post dose
Measured: Up to 28 days
Pharmacokinetics- AUCτ
Area under the plasma concentration-time curve from time zero to tau (τ), where τ is the dosing interval
Measured: Up to 28 days
Pharmacokinetics- t1/2
Terminal elimination half-life
Measured: Up to 28 days
Pharmacokinetics- CL/F
Apparent total plasma clearance when dosed orally
Measured: Up to 28 days
Pharmacokinetics- Vz/F
Apparent total volume of distribution when dosed orally, based on the terminal phase
Measured: Up to 28 days
Pharmacokinetics- RAc
Ratio of accumulation
Measured: Up to 28 days
Quality of Life Analysis
Dermatology Life Quality Index will be used to assess quality of life throughout study
Measured: Up to Day 36
Body Surface Area Involvement
Standard body surface area grading scale will be used to assess severity of psoriasis throughout study
Measured: Up to Day 36
Psoriasis Area and Severity Index Scores
Standard psoriasis area and severity index scale will be used to assess severity of psoriasis throughout study
Measured: Up to Day 36
Static Physicians Global Assessment score
Static physicians global assessment score will be used to assess severity of psoriasis throughout study
Measured: Up to Day 36
Effect of CC-90005 on ECG parameters
12-lead ECGs will be extracted from continuous Holter recordings and used to assess the effect of CC-90005 on ECG parameters
Measured: Up to 50 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study start17 Jul 2015
- Primary completion2 Nov 2015
- Study completion2 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParapsoriasisStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Palmisano, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502188
- Sponsor's protocol ID
- CC-90005-CP-001
- Status last verified
- Nov 2019
- First submitted
- 16 Jul 2015
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CC-90005 in Healthy Subjects and Subjects With Moderate to Severe Plaque-type Psoriasis
- ClinicalTrials.gov ID
- NCT02502188
- Acronym / sponsor ID
- CC-90005-CP-001
- Conditions
- Parapsoriasis, Healthy Volunteers
- Keywords
- Healthy Subjects, Severe Plaque Psoriasis, Moderate, Phase 1, Safety, Tolerability, CC-90005
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2015 (actual)
- Primary completion
- 2 Nov 2015 (actual)
- Study completion
- 2 Nov 2015 (actual)
- First posted
- 20 Jul 2015 (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.
To evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of CC-90005 in healthy subjects and subjects with moderate to severe plaque-type psoriasis.
Detailed description
This is a 2-part study to be conducted at multiple study centers. Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90005 following a single oral dose in healthy subjects. During the course of Part 1, each subject will participate in a screening phase, baseline phase(s), treatment phase(s) and a follow up visit. There will be a total of 3 planned cohorts, each of which will consist of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC 90005 and 2 subjects will receive placebo depending on the randomization schedule. Each cohort will receive a minimum of 2 doses, with one of the cohorts receiving a third dose (up to three study periods per cohort). Administration of study drug at the next higher dose level will not begin until the safety and tolerability of the preceding dose have been evaluated and deemed acceptable by the investigator and sponsor's medical monitor. Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90005 following multiple oral doses in subjects with moderate to severe plaque-type psoriasis. During the course of Part 2, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow up visit. There will be a total of 4 planned cohorts, each of which will consist of a different dose level, with 12 subjects per cohort. In each cohort, 9 subjects will receive a dose of CC-90005 and 3 subjects will receive placebo depending on the randomization schedule. It is planned for study drug to be administered twice daily for 28 days. Proposed dose levels in Part 2 may be modified and/or eliminated based on data obtained from Part 1 and/or from previous data obtained in Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 - CC-90005 and Placebo | Experimental | Drug: CC-90005, Drug: PlaceboCC-90005 or Placebo will be administered orally from low to high dose |
| Part 2 - CC-90005 and Placebo | Experimental | Drug: CC-90005, Drug: PlaceboCC-90005 or Placebo will be administered orally from low to high dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (42 listed)
- Part 1 (Healthy Subjects)
- Female or male subject is ≥ 18 and ≤ 65 years of age at the time of signing the informed consent form (ICF).
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject is in good health as determined by a physical examination at screening.
Key exclusion criteria (49 listed)
- Part 1 (Healthy Subjects)
- Subject has any significant and relevant medical condition (including but not limited to neurological, gastrointestinal (GI), renal, hepatic, CV, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject is pregnant or breastfeeding.
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-90005 | Drug | Part 1 - CC-90005 and Placebo, Part 2 - CC-90005 and Placebo |
| Placebo | Drug | Part 1 - CC-90005 and Placebo, Part 2 - CC-90005 and Placebo |
Primary outcome
Adverse Events (AEs)
Time frame: Up to 12 months
Number of participants with adverse events
15 secondary outcomes
Pharmacokinetics- Cmax
Time frame: Up to 28
Pharmacokinetics- Tmax
Time frame: Up to 28
Pharmacokinetics- AUC∞
Time frame: Up to 28 days
Pharmacokinetics- AUCt
Time frame: Up to 28 days
Pharmacokinetics- AUC24
Time frame: Up to 28 days
Pharmacokinetics- AUCτ
Time frame: Up to 28 days
Pharmacokinetics- t1/2
Time frame: Up to 28 days
Pharmacokinetics- CL/F
Time frame: Up to 28 days
Pharmacokinetics- Vz/F
Time frame: Up to 28 days
Pharmacokinetics- RAc
Time frame: Up to 28 days
Quality of Life Analysis
Time frame: Up to Day 36
Body Surface Area Involvement
Time frame: Up to Day 36
Psoriasis Area and Severity Index Scores
Time frame: Up to Day 36
Static Physicians Global Assessment score
Time frame: Up to Day 36
Effect of CC-90005 on ECG parameters
Time frame: Up to 50 hours
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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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.
Maria Palmisano, MD study director
Celgene Corporation
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 CC-90005 in people with Parapsoriasis and Healthy Volunteers, run by Celgene at 1 site 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 42 inclusion and 49 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 18 Nov 2019. 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 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 was stopped early. 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?
Adverse Events (AEs) (time frame: Up to 12 months). 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 18 Nov 2019.