PsoriasisPhase 2NCT00684593
A Study to Assess the Clinical Effects of Navarixin in Participants With Psoriasis (MK-7123-009)
A Phase 2 study testing Navarixin 10 mg in people with Psoriasis, run by Merck Sharp & Dohme LLC.
Trial summary
This study was conducted: 1) to assess the clinical effect of Navarixin on the Psoriasis Activity and Severity Index (PASI), 2) to determine the effects of Navarixin on the Physician's Global Assessment (PGA), 3) to evaluate the safety and tolerability of Navarixin, and 4) to determine the multiple-dose… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Navarixin 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2007to 1 Oct 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) 19 to 34, BMI = weight (kg)/height (m^2).
- Must have a diagnosis of psoriasis vulgaris (PASI >8) present for at least 1 year. Participants with an on-therapy PASI <=8 at Screening may be considered for inclusion. Participants must be discussed with the Sponsor prior to enrollment and the subject must have indicated that they are not satisfied with current therapy. To be included, participants must have a PASI >8 following washout of their current psoriasis therapy.
- Target lesion selected must be located on the head, trunk, arms or legs and be at least 10 cm^2 in size. The lesion's total numerical ratings for erythema, infiltration, and desquamation must be at least 6 out of the possible 12. Severity score for desquamation must be at least 2.
- Vital sign measurements (taken after ~3 minutes in a supine position) must be within the following ranges: oral body temperature between 35.0°C to 37.5°C; systolic blood pressure, 90 to 160 mm Hg; diastolic blood pressure, 45 to 90 mm Hg; pulse rate, 40 to 100 bpm.
- Have stable disease (ie, off treatment PASI during Screening period and Baseline PASI should not differ by more than 40%).
- Clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. Participants must have a neutrophil count of at least 2 x 10^9/L to be included.
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- Free of any clinically significant disease (other than psoriasis).
- Willing to give written informed consent and able to adhere to dose and visit schedules.
- For female participants: Negative serum pregnancy test (beta-hCG) and urine pregnancy test. Agree to use medically accepted methods of contraception during and for an appropriate pre-study period while receiving protocol specified medication, and for 1 month after stopping medication. Female participants of non-childbearing potential must be surgically sterilized or be postmenopausal.
- Male subject must agree to use an adequate form of contraception for the duration of the study.
- At Screening, ECG conduction intervals must be within gender specific normal range (ie, QTc for males <430 msec and females <450 msec) or if not within the normal range, the values must be considered clinically insignificant by the investigator and sponsor.
Who cannot join
- Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding.
- Participants who, in the opinion of the investigator, will not be able to participate optimally in the study.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
- History of any infectious disease within 4 weeks prior to drug administration and/or are positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
- Immunocompromised participants.
- Positive screen for drugs with a high potential for abuse or have a history of drug or alcohol abuse in the past 2 years.
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- History of mental instability or who have been treated for mood disorders.
- Donated blood in the past 60 days.
- Previous treatment with study medication.
- Currently participating in another clinical study or have participated in a clinical study within 30 days.
- Part of the study staff personnel or family members of the study staff personnel.
- Demonstrated clinically significant (requiring intervention) allergic reactions or who are known to be allergic to components of local anesthetics.
About this study
Official title: A Study to Assess the Clinical Effects of SCH 527123 in Psoriasis
This study was conducted: 1) to assess the clinical effect of Navarixin on the Psoriasis Activity and Severity Index (PASI), 2) to determine the effects of Navarixin on the Physician's Global Assessment (PGA), 3) to evaluate the safety and tolerability of Navarixin, and 4) to determine the multiple-dose pharmacokinetics of Navarixin.
- Conditions
- Psoriasis
- Being tested
- Navarixin 10 mg, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navarixin 10 mgDrug
Navarixin capsules orally, once daily for 28 days.
PlaceboOther
Matching placebo capsules to Navarixin orally, once daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Navarixin | Experimental | Navarixin 30 mg administered orally once daily for 28 days. Receives: Drug: Navarixin 10 mg |
| Placebo | Placebo comparator | Matching placebo to Navarixin administered orally once daily for 28 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29
PASI score is a means to qualify the extent and severity of psoriatic lesions. The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).
Measured: Baseline and Day 29
Secondary outcomes (5)
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
The PGA is a questionnaire that asks the treating physician to rate the participant's signs and symptoms on a scale where 0=worse, 1=unchanged, 2= slight improvement, 3= fair improvement, 4= good improvement, 5= excellent improvement, and 6=cleared, with higher scores indicating better outcomes.
Measured: Day 29
Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean Cmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.
Measured: Day 28
Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean AUC(0-24) at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.
Measured: Day 28
Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours to determine the mean T1/2 of Navarixin following oral administration at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.
Measured: Day 28
Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the Mean Tmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study start1 Jun 2007
- Primary completion1 Oct 2007
- Study completion1 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684593
- Sponsor's protocol ID
- P04481
- Other IDs
- 2006-006601-83, P04481
- Status last verified
- Jan 2019
- First submitted
- 22 May 2008
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Clinical Effects of SCH 527123 in Psoriasis
- ClinicalTrials.gov ID
- NCT00684593
- Acronym / sponsor ID
- P04481
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2007 (actual)
- Primary completion
- 1 Oct 2007 (actual)
- Study completion
- 1 Oct 2007 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 6 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted: 1) to assess the clinical effect of Navarixin on the Psoriasis Activity and Severity Index (PASI), 2) to determine the effects of Navarixin on the Physician's Global Assessment (PGA), 3) to evaluate the safety and tolerability of Navarixin, and 4) to determine the multiple-dose pharmacokinetics of Navarixin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navarixin | Experimental | Drug: Navarixin 10 mgNavarixin 30 mg administered orally once daily for 28 days. |
| Placebo | Placebo comparator | Other: PlaceboMatching placebo to Navarixin administered orally once daily for 28 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Body Mass Index (BMI) 19 to 34, BMI = weight (kg)/height (m^2).
- Must have a diagnosis of psoriasis vulgaris (PASI >8) present for at least 1 year. Participants with an on-therapy PASI <=8 at Screening may be considered for inclusion. Participants must be discussed with the Sponsor prior to enrollment and the subject must have indicated that they are not satisfied with current therapy. To be included, participants must have a PASI >8 following washout of their current psoriasis therapy.
- Target lesion selected must be located on the head, trunk, arms or legs and be at least 10 cm^2 in size. The lesion's total numerical ratings for erythema, infiltration, and desquamation must be at least 6 out of the possible 12. Severity score for desquamation must be at least 2.
- Vital sign measurements (taken after ~3 minutes in a supine position) must be within the following ranges: oral body temperature between 35.0°C to 37.5°C; systolic blood pressure, 90 to 160 mm Hg; diastolic blood pressure, 45 to 90 mm Hg; pulse rate, 40 to 100 bpm.
- Have stable disease (ie, off treatment PASI during Screening period and Baseline PASI should not differ by more than 40%).
Key exclusion criteria (12 listed)
- Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding.
- Participants who, in the opinion of the investigator, will not be able to participate optimally in the study.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
- History of any infectious disease within 4 weeks prior to drug administration and/or are positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
- Immunocompromised participants.
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 |
|---|---|---|
| Navarixin 10 mgNavarixin capsules orally, once daily for 28 days. | Drug | Navarixin |
| PlaceboMatching placebo capsules to Navarixin orally, once daily for 28 days. | Other | Placebo |
Primary outcome
Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29
Time frame: Baseline and Day 29
PASI score is a means to qualify the extent and severity of psoriatic lesions. The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).
5 secondary outcomes
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
Time frame: Day 29
Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28
Time frame: Day 28
Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28
Time frame: Day 28
Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28
Time frame: Day 28
Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Navarixin 10 mg in people with Psoriasis, run by Merck Sharp & Dohme LLC.
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 11 inclusion and 12 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 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29 (time frame: Baseline and Day 29). 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 Feb 2019.