PsoriasisPhase 2NCT02872285
An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis
A Phase 2 study testing Drug: LYC-30937-EC in people with Psoriasis, run by Lycera Corp. at 7 sites in United States.
Trial summary
The objective of this Phase 2 trial is to determine the efficacy and safety of LYC-30937-EC in patients with moderate plaque-type psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Drug: LYC-30937-EC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Dec 2016to 22 Jun 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of plaque-type psoriasis for at least 6 months prior to screening.
- Must have chronic moderate plaque-type psoriasis confirmed at both screening and baseline visits. Moderate plaque-type psoriasis is defined as a PASI > 7, with body surface area (BSA) involvement 5-15% inclusive and overall lesion severity of "moderate" or "marked, " where "moderate" = plaque elevation (0.75mm), moderate red coloration, coarse scale predominates; "marked" = moderate plaque elevation (1.0mm), bright red coloration, and thick, non-tenacious scale predominates.
- Female subjects of childbearing potential must agree to use two highly effective forms of contraception during study participation and for 30 days after their last dose of treatment of study drug treatment.
- Male subjects with partners of childbearing potential must take appropriate precautions to avoid fathering a child while participating in the study and use appropriate barrier contraception or abstinence during the study and for 30 days after their last dose of study drug.
- Agree to avoid prolonged sun exposure and avoid tanning booths or ultraviolet (UV) light sources during the study.
- Ability to provide written informed consent and to be compliant with the schedule of events.
Who cannot join
- Non-plaque-type psoriasis (eg, pustular, erythrodermic, and guttate psoriasis).
- Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel blockers, or lithium).
- Spontaneously improving or rapidly deteriorating plaque psoriasis.
- Comorbid psoriatic arthritis that is not amenable to treatment with NSAIDs.
- Treatment with a biologic agent for psoriasis.
- Failed 2 or more systemic treatments for plaque psoriasis.
Show all 21Show fewer
- Received phototherapy or prolonged sun exposure or use of tanning booth or other ultraviolet light source within 4 weeks of initiating screening procedures.
- Received systemic drug therapy (non-biologic) for plaque psoriasis or any systemic medication that could affect psoriasis or its evaluation (PASI or IGA), including but not limited to oral or injectable corticosteroids, retinoids, sulfasalazine, within 4 weeks of initiating screening procedures.
- Received topical medication that could affect psoriasis or its evaluation (PASI or IGA), including but not limited to corticosteroids, retinoids, topical vitamin D derivatives, pimecrolimus, tacrolimus, calcipotriene, within 2 weeks of initiating screening procedures.
- Received immunosuppressant agents (eg, cyclosporine, azathioprine, methotrexate) within 8 weeks of initiating screening procedures.
- Any of the following laboratory abnormalities:
- liver function tests > 1.5 x the upper limit of normal (ULN) or direct bilirubin > 1.5 x ULN
- hemoglobin < 8.5 g/dl (international system units [SI]: < 85 g/L)
- neutrophils < 1500/mm3 (SI: < 1.5 x 109/L)
- white blood cell (WBC) count < 3,000/mm3 (SI: < 3.0 x 109/L)
- platelets < 80,000 mm3 (SI: 80 x 109/L)
- international normalized ratio (INR) > 1.5
- serum creatinine > 1.4 mg/dL for women or > 1.6 mg/dL for men
- Clinically relevant hepatic, neurological, pulmonary, dermatological, ophthalmological, gastrointestinal, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study.
- History of or currently active primary or secondary immunodeficiency.
- Treatment with an investigational agent within 30 days prior to initiating screening procedures.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Lycera Investigational Site
Andover, Massachusetts, 01810
Lycera Investigational Site
Broomall, Pennsylvania, 19008
Lycera Investigational Site
Carmel, Indiana, 46032
Lycera Investigational Site
East Windsor, New Jersey, 08520
Lycera Investigational Site
Fridley, Minnesota, 55432
Lycera Investigational Site
High Point, North Carolina, 27262
Lycera Investigational Site
Norfolk, Virginia, 23502
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of LYC-30937-EC in Subjects With Moderate Chronic Plaque-Type Psoriasis
The objective of this Phase 2 trial is to determine the efficacy and safety of LYC-30937-EC in patients with moderate plaque-type psoriasis.
Read the detailed description
Approximately 30 subjects will be enrolled in this double-blind, placebo-controlled study. The randomization will be stratified 2:1 into the LYC-30937-EC cohort (2) or the placebo cohort (1). The active cohort will receive LYC-30937-EC 25 mg once daily, which demonstrated safety and tolerability in Phase I trials.
The study is designed for patients with previously diagnosed moderate chronic plaque-type psoriasis and consists of the following:
- Screening period (initials assessment and eligibility scoring)
- Day 1: confirm eligibility, baseline efficacy assessments (PASI, IGA), randomize and initiate dosing
- Week 2: safety assessments including vital signs, body temperature, physical exam, clinical labs will be performed
- Week 4: efficacy (PASI, IGA) and safety assessments including vital signs, body temperature, physical exam, and clinical labs will be performed
- Week 8: efficacy (PASI, IGA) and safety assessments including vital signs, body temperature, physical exam, and clinical labs will be performed
- Week 12: final efficacy assessments (PASI, IGA), safety assessments including vital signs, body temperature, physical exam, ECG, and clinical labs will be performed
- Week 14: final safety assessments including vital signs, body temperature, and clinical labs
- Conditions
- Psoriasis
- Being tested
- Drug: LYC-30937-EC, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: LYC-30937-ECDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| LYC-30937-EC 25 mg PO once daily (QD) | Experimental | LYC-30937-EC 25 mg by mouth once daily for 12 weeks Receives: Drug: Drug: LYC-30937-EC |
| Matching Placebo PO QD | Placebo comparator | Placebo enteric coated (EC) by mouth once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mean Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI).
This endpoint was calculated in each treatment group by taking the Week 12 PASI score and subtracting the baseline PASI and dividing by the baseline PASI, then multiplying by 100 to get the percent change from baseline. The PASI is a measure of chronic plaque-type psoriasis disease. It combines lesion severity (erythema, thickness, scaling) and skin surface area involvement in 4 defined anatomical body regions (head, upper extremities, trunk, lower extremities). PASI score ranges from 0 to 72 with higher scores indicative of greater disease severity. Lesion severity (erythema, thickness, scaling) is scored on a scale of 0 (none) to 4 (very severe) on each of the 4 body regions. Degree of skin area involvement in each body region is scored on a scale of 0 (no involvement) to 6 (90-100% involvement).
Measured: Baseline to Week 12
Secondary outcomes (4)
The Number of Subjects Who Achieve a ≥ 75% Reduction From Baseline in PASI at Week 12.
This endpoint calculated the number of subjects achieving a ≥ 75% reduction in their Week 12 PASI score compared to their baseline PASI.
The PASI is a measure of chronic plaque-type psoriasis disease. It combines lesion severity (erythema, thickness, scaling) and skin surface area involvement in 4 defined anatomical body regions (head, upper extremities, trunk, lower extremities). PASI score ranges from 0 to 72 with higher scores indicative of greater disease severity. Lesion severity (erythema, thickness, scaling) is scored on a scale of 0 (none) to 4 (very severe) on each of the 4 body regions. Degree of skin area involvement in each body region is scored on a scale of 0 (no involvement) to 6 (90-100% involvement).
Measured: Baseline to Week 12
The Mean Percent Change From Baseline to Week 12 in Percent Body Surface Area (BSA).
Mean percent change from baseline to Week 12 in %BSA was calculated by taking the Week 12 %BSA and subtracting the baseline %BSA then dividing by the baseline %BSA and multiplying by 100. The mean percent change from baseline to Week 12 in each treatment group were compared using analysis of covariance with treatment as a factor and baseline as a covariate.
Measured: Baseline to Week 12
The Number of Subjects Who Achieve "Cleared" (Score = 0) or "Minimal" (Score = 1) on the Static Investigators Global Assessment at Week 12.
This endpoint is number of subjects who achieved a score of 0 or 1 on the static IGA at week 12. The static IGA is used to measure psoriasis severity. The static IGA used in this study was a 6-point scale: 0 = Cleared [no plaque elevation, erythema or scaling, hyperpigmentation may be present]; 1 = Minimal [minimal plaque elevation (=0.25mm), faint erythema, minimal scaling with occasional fine scale over < 5% of lesion]; 2 = Mild [mild plaque elevation (=0.5mm), light red coloration, fine scale predominates]; 3 = Moderate [moderate plaque elevation (=0.75mm), moderate red coloration, coarse scale predominates]; 4 = Marked (marked plaque elevation (=1mm), bright red coloration, thick non-tenacious scale predominates]; 5 = Severe (severe plaque elevation (≥1.25mm), dusky to deep red coloration, very thick tenacious scale predominates].
Measured: 12 weeks
The Number of Subjects Who Achieve a 2 Step Reduction on the Static Investigators Global Assessment (IGA) at Week 12.
This endpoint is based on number of subjects who achieved a 2 step reduction in the static IGA at week 12 (ie, a score of 5 at baseline to a score of 3 or less at Week 12). The static IGA is used to measure psoriasis severity. The static IGA used in this study was a 6-point scale: 0 = Cleared [no plaque elevation, erythema or scaling, hyperpigmentation may be present]; 1 = Minimal [minimal plaque elevation (=0.25mm), faint erythema, minimal scaling with occasional fine scale over < 5% of lesion]; 2 = Mild [mild plaque elevation (=0.5mm), light red coloration, fine scale predominates]; 3 = Moderate [moderate plaque elevation (=0.75mm), moderate red coloration, coarse scale predominates]; 4 = Marked (marked plaque elevation (=1mm), bright red coloration, thick non-tenacious scale predominates]; 5 = Severe (severe plaque elevation (≥1.25mm), dusky to deep red coloration, very thick tenacious scale predominates].
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start5 Dec 2016
- Primary completion22 Jun 2017
- Study completion22 Jun 2017
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lycera Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872285
- Sponsor's protocol ID
- LYC-30937-2003
- Status last verified
- Apr 2019
- First submitted
- 16 Aug 2016
- Last updated
- 10 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of LYC-30937-EC in Subjects With Moderate Chronic Plaque-Type Psoriasis
- ClinicalTrials.gov ID
- NCT02872285
- Acronym / sponsor ID
- LYC-30937-2003
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Lycera Corp.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Posted 2 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this Phase 2 trial is to determine the efficacy and safety of LYC-30937-EC in patients with moderate plaque-type psoriasis.
Detailed description
Approximately 30 subjects will be enrolled in this double-blind, placebo-controlled study. The randomization will be stratified 2:1 into the LYC-30937-EC cohort (2) or the placebo cohort (1). The active cohort will receive LYC-30937-EC 25 mg once daily, which demonstrated safety and tolerability in Phase I trials.
The study is designed for patients with previously diagnosed moderate chronic plaque-type psoriasis and consists of the following:
- Screening period (initials assessment and eligibility scoring)
- Day 1: confirm eligibility, baseline efficacy assessments (PASI, IGA), randomize and initiate dosing
- Week 2: safety assessments including vital signs, body temperature, physical exam, clinical labs will be performed
- Week 4: efficacy (PASI, IGA) and safety assessments including vital signs, body temperature, physical exam, and clinical labs will be performed
- Week 8: efficacy (PASI, IGA) and safety assessments including vital signs, body temperature, physical exam, and clinical labs will be performed
- Week 12: final efficacy assessments (PASI, IGA), safety assessments including vital signs, body temperature, physical exam, ECG, and clinical labs will be performed
- Week 14: final safety assessments including vital signs, body temperature, and clinical labs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LYC-30937-EC 25 mg PO once daily (QD) | Experimental | Drug: Drug: LYC-30937-ECLYC-30937-EC 25 mg by mouth once daily for 12 weeks |
| Matching Placebo PO QD | Placebo comparator | Drug: PlaceboPlacebo enteric coated (EC) by mouth once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a diagnosis of plaque-type psoriasis for at least 6 months prior to screening.
- Must have chronic moderate plaque-type psoriasis confirmed at both screening and baseline visits. Moderate plaque-type psoriasis is defined as a PASI > 7, with body surface area (BSA) involvement 5-15% inclusive and overall lesion severity of "moderate" or "marked, " where "moderate" = plaque elevation (0.75mm), moderate red coloration, coarse scale predominates; "marked" = moderate plaque elevation (1.0mm), bright red coloration, and thick, non-tenacious scale predominates.
- Female subjects of childbearing potential must agree to use two highly effective forms of contraception during study participation and for 30 days after their last dose of treatment of study drug treatment.
- Male subjects with partners of childbearing potential must take appropriate precautions to avoid fathering a child while participating in the study and use appropriate barrier contraception or abstinence during the study and for 30 days after their last dose of study drug.
- Agree to avoid prolonged sun exposure and avoid tanning booths or ultraviolet (UV) light sources during the study.
Key exclusion criteria (21 listed)
- Non-plaque-type psoriasis (eg, pustular, erythrodermic, and guttate psoriasis).
- Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel blockers, or lithium).
- Spontaneously improving or rapidly deteriorating plaque psoriasis.
- Comorbid psoriatic arthritis that is not amenable to treatment with NSAIDs.
- Treatment with a biologic agent for psoriasis.
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 |
|---|---|---|
| Drug: LYC-30937-EC | Drug | LYC-30937-EC 25 mg PO once daily (QD) |
| Placebo | Drug | Matching Placebo PO QD |
Primary outcome
The Mean Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI).
Time frame: Baseline to Week 12
This endpoint was calculated in each treatment group by taking the Week 12 PASI score and subtracting the baseline PASI and dividing by the baseline PASI, then multiplying by 100 to get the percent change from baseline. The PASI is a measure of chronic plaque-type psoriasis disease. It combines lesion severity (erythema, thickness, scaling) and skin surface area involvement in 4 defined anatomical body regions (head, upper extremities, trunk, lower extremities). PASI score ranges from 0 to 72 with higher scores indicative of greater disease severity. Lesion severity (erythema, thickness, scaling) is scored on a scale of 0 (none) to 4 (very severe) on each of the 4 body regions. Degree of skin area involvement in each body region is scored on a scale of 0 (no involvement) to 6 (90-100% involvement).
4 secondary outcomes
The Number of Subjects Who Achieve a ≥ 75% Reduction From Baseline in PASI at Week 12.
Time frame: Baseline to Week 12
The Mean Percent Change From Baseline to Week 12 in Percent Body Surface Area (BSA).
Time frame: Baseline to Week 12
The Number of Subjects Who Achieve "Cleared" (Score = 0) or "Minimal" (Score = 1) on the Static Investigators Global Assessment at Week 12.
Time frame: 12 weeks
The Number of Subjects Who Achieve a 2 Step Reduction on the Static Investigators Global Assessment (IGA) at Week 12.
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug: LYC-30937-EC in people with Psoriasis, run by Lycera Corp. at 7 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 6 inclusion and 21 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 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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 2 Apr 2019). 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?
The Mean Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI). (time frame: Baseline to Week 12). 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 10 Apr 2019.