Intra-dermal Injections of DLX105 Into Lesional Skin in Patients With Mild-to-moderate Psoriasis Vulgaris

NCT01595997 | Completed Phase 1 DMC

• 1 other identifier: DLX105-003-001-001
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

Brief Summary

The overall purpose of this study is to support the development of a DLX105 topical formulation for the indication mild to moderate psoriasis vulgaris.

Conditions

Mild-to-moderate Psoriasis Vulgaris

Keywords

safety tolerability and immunogenicity of two different doses of DLX105 applied intra-dermally into psoriatic lesion of mild-to-moderate psoriatic patients

Outcome Measures

Primary Outcomes (1)

• Local tolerability: Investigator's assessment of local tolerability using a validated score for each treatment area. Patient's assessment of subjective tolerability sensations (burning, itching, pain) recorded on a visual analogue scale (VAS) (0-10

  28 days

Secondary Outcomes (2)

• Safety variables:

  28 days

• Efficacy variables

  28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: DLX105

DLX105

EXPERIMENTAL

Drug: DLX105

Interventions

DLX105 DRUG

intradermal injections (volume: 0.1 mL) of 0.02 mg (low dose cohort), 1 mg (high dose cohort) DLX105, days: Day 1, Day 4, Day 7 and Day 10

DLX105; Placebo

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
• 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 pronounced but not active lesions of \>9 cm2 each, stable for at least 3 months, local PASI score ≥8. Distance between lesions must be at least 30 cm.
• Affected body surface area (BSA) ≤10%
• Negative pregnancy test for females of child bearing potential (pre-menopausal, \<2 years post-menopausal, not surgically sterile)

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type (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 psoriasis treatments (duration of washout, i.e. discontinuation prior to randomization):
• Alefacept (6 months)
• Biological agents other than alefacept, e.g. adalimumab, efalizumab, etanercept, infliximab, ustekinumab (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 treatments, except in face, scalp and genital area during screening (2 weeks)
• Other investigational psoriasis drugs (4 weeks or 5 half-lives, whichever is longer)
• Ongoing use of other (non-psoriasis) treatments (duration of washout, i.e. discontinuation prior to randomization):
• Investigational drugs, not psoriasis drugs (4 weeks or 5 half-lives, whichever is longer)
• Known immunosuppression
• 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

Sponsors & Collaborators

• Delenex Therapeutics AG: lead

Study Sites (2)

Universitätsklinikum

Vienna, Austria

Location

Universitätsklinikum Münster (UKM)

Münster, 48149, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 10, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

AU (1); DE (1)