Topical Double-blind, Randomized, Placebo-controlled Study in Psoriasis Patients

NCT01936337 | Completed Phase 2

• 1 other identifier: DLX105-003-002-001
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 3

Brief Summary

In this study, the safety, tolerability and efficacy of DLX105 administered topically onto the psoriatic lesion of mild-to-moderate psoriasis patients will be investigated.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (5)

• Assessment of local tolerability by the investigator

  using a validated score for each treatment area

  up to 6 weeks

• assessment of local tolerability sensations by the patient

  using a visual analogue scale for each treatment area

  up to 6 weeks

• collection of Adverse Events

  up to 6 weeks

• Determination of efficacy of DLX105 as compared to baseline

  assessment of Local PASI score per plaque measured at week 4 compared to baseline

  Baseline to Week 4

• Determination of efficacy of DLX105 as compared to Placebo at week 4

  Local PASI difference at week 4 between DLX105 and placebo

  baseline to week 4

Secondary Outcomes (2)

• Detection of Immunogenicity

  up to 6 weeks

• Detection of Pharmacokinetics

  up to 6 weeks

Study Arms (2)

DLX105 Hydrogel

ACTIVE COMPARATOR

Drug: DLX105 Hydrogel

Placebo Hydrogel

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DLX105 Hydrogel DRUG

topical administration on psoriatic plaque

DLX105 Hydrogel

Placebo DRUG

topical administration on psoriatic plaque

Placebo Hydrogel

Eligibility Criteria

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

You may qualify if:

• Signed and dated informed consent prior to initiation of any study procedures.
• Male or female Caucasian aged 18-75 years.
• Male or female patients with stable chronic mild-to-moderate plaque-type psoriasis (PASI ≤15).
• Male or female Caucasian patients with stable chronic mild-to-moderate plaque-type psoriasis (PASI ≤15) aged 18-75 years who must have at least two psoriasis lesions of \>9 cm2 (located at arms and/or trunk, excluding elbows and legs), stable for at least 3 months, local PASI score ≥8.
• Affected body surface area (BSA) ≤10%.
• Negative pregnancy test for females of child-bearing potential (pre-menopausal, \<2 years post-menopausal, not surgically sterile).
• Willing and able to participate in the trial as an outpatient and comply with all trial requirements.

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, plantar or nail disease) at screening.
• Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) prior to randomization
• Ongoing use of prohibited psoriasis treatments (duration of washout, i.e. discontinuation prior to randomization):
• Biological agents, e.g. adalimumab, etanercept, infliximab, ustekinumab, alefacept (12 weeks)
• Systemic therapy for psoriasis and psoriatic arthritis (other than above) e.g. methotrexate, cyclosporin, fumaric acid (derivatives), systemic steroids (4 weeks)
• Photochemotherapy e.g., ultraviolet A with psoralen (PUVA) (4 weeks)
• Phototherapy e.g., ultraviolet A (UVA) or ultraviolet B (UVB) (2 weeks)
• Topical therapies for the treatment of Ps such as corticosteroids, vitamin D analogues or retinoids within 14 days prior to baseline
• Other investigational psoriasis drugs (4 weeks or 5 half-lives, whichever is longer)
• Intake of any investigational drug or participation in a Clinical Trial within 4 weeks or 5 half-lives, (whichever is longer) prior to baseline.
• History or evidence of active tuberculosis. All patients will be tested for tuberculosis status using a blood test (QuantiFERON TB-Gold) unless this test has been performed within 4 months prior to randomization and was negative. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
• Active systemic infections (other than common cold) during the two weeks before randomization
• Positive test for hepatitis B or C at screening
• Positive test for HIV at screening
• History or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratosis, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

Sponsors & Collaborators

• Delenex Therapeutics AG: lead

Study Sites (3)

University Hospital AKH

Vienna, Austria

Location

University Hospital

Münster, Germany

Location

University Hospital

Tübingen, Germany

Location

Study Design

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

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 6, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 12, 2014

Record last verified: 2014-08

Locations

DE (2); AU (1)