An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis

NCT02872285 | Completed Phase 2 Results DMC

• 1 other identifier: LYC-30937-2003
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline to Week 12

Secondary Outcomes (4)

• The Number of Subjects Who Achieve a ≥ 75% Reduction From Baseline in PASI at Week 12.

  Baseline to Week 12

• The Mean Percent Change From Baseline to Week 12 in Percent Body Surface Area (BSA).

  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.

  12 weeks

• The Number of Subjects Who Achieve a 2 Step Reduction on the Static Investigators Global Assessment (IGA) at Week 12.

  12 weeks

Study Arms (2)

LYC-30937-EC 25 mg PO once daily (QD)

EXPERIMENTAL

LYC-30937-EC 25 mg by mouth once daily for 12 weeks

Drug: Drug: LYC-30937-EC

Matching Placebo PO QD

PLACEBO COMPARATOR

Placebo enteric coated (EC) by mouth once daily for 12 weeks

Drug: Placebo

Interventions

Drug: LYC-30937-EC DRUG

LYC-30937-EC 25 mg PO once daily (QD)

Placebo DRUG

Matching Placebo PO QD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Lycera Corp.: lead

Study Sites (7)

Lycera Investigational Site

Carmel, Indiana, 46032, United States

Location

Lycera Investigational Site

Andover, Massachusetts, 01810, United States

Location

Lycera Investigational Site

Fridley, Minnesota, 55432, United States

Location

Lycera Investigational Site

East Windsor, New Jersey, 08520, United States

Location

Lycera Investigational Site

High Point, North Carolina, 27262, United States

Location

Lycera Investigational Site

Broomall, Pennsylvania, 19008, United States

Location

Lycera Investigational Site

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: H. Jeffrey Wilkins MD, Chief Medical Officer
• Organization: Lycera Corp.

wilkins@lycera.com

484-243-6222

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 19, 2016
• Study Start: December 5, 2016
• Primary Completion: June 22, 2017
• Study Completion: June 22, 2017
• Last Updated: April 10, 2019
• Results First Posted: April 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)