Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Moleculin, LLC
ClinicalTrials.gov Identifier:
NCT01826201
First received: March 21, 2013
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine whether MOL4239 is effective in adult subjects with mild to moderate plaque psoriasis by comparing two target lesions in which each subject will apply MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days.


Condition Intervention Phase
Psoriasis
Drug: MOL4239
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Blinded, Paired Psoriasis Lesion, Comparative, Placebo-controlled Study to Evaluate the Safety, Preliminary Efficacy and Pharmacokinetics of Epidermal Administrations of MOL4239 in Adults With Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Moleculin, LLC:

Primary Outcome Measures:
  • Mean change from baseline to day 28 in PSS (Psoriasis Severity score) of the treatment target lesions compared to placebo target lesions [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
    Change from baseline to day 28 in mean PSS (Psoriasis Severity score) among treatment groups (i.e. MOL4239 versus placebo). The change from baseline will be determined as the difference between the means for the treatment period (day 28) and the baseline.


Secondary Outcome Measures:
  • Improvement in lesion appearance [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
    Photography of the MOL4239 and placebo treated lesions will be performed at baseline, Day 7, Day 14 and Day 28 to assess for the improvement in lesion appearance after drug treatment. The assessment will be completed by a blinded panel of dermatologists experienced in the assessment of psoriasis.

  • Physician's treatment preference [ Time Frame: Day 7, Day 14, Day 28 ] [ Designated as safety issue: No ]
    The physician's treatment preference utilizing visual assessment and selection of the most improved plaque. The determination will be either 1)right lesion is preferred compared to left, 2)left lesion is preferred compared to right, 3) no difference between the right and left lesion.

  • Treatment success [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
    Percent of patients achieving treatment success in the treatment group compared to the placebo group on day 28. Treatment success is defined as patient achieving a psoriasis severity score (PSS) of 3 or less, or an improvement of 5 points or more on the PSS.

  • Change in EIS area [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
    Change in Erythema, Induration and Scale (EIS) area. Total score will be the EIS x Area, and will be calculated at baseline, Day 7, Day 14 and Day 28. The EIS will represent the sum of individual scores of Erythema, Induration and Scale using the same scale utilized in the PSS. The area of active erythema, induration and scale will be measured and the total scores will be calculated from the EIS scores multiplied by the area in cm2.

  • Safety assessment [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: Yes ]
    Safety will be assessed based on reported adverse events, physical examination, vital signs, electrocardiograms, hematology, serum chemistry and urinalysis. Adverse events will be reported throughout the trial. Vital signs will be performed at screening, baseline, prior to the morning dose on Days 0, 1, 7, 14, 28, and at the follow up visit on Day 42. Physical examinations will be performed at Screening, baseline and Day 28. Hematology, serum chemistry and urinalysis will be performed at screening, baseline, Days 1, 7, 14, 28, and at the follow up visit on Day 42. ECGs will be performed at Screening, baseline and Day 28.


Other Outcome Measures:
  • Plasma MOL4239 concentration time data [ Time Frame: Before and after first dose on Day 0 and before and after the last dose on Day 28 ] [ Designated as safety issue: No ]
    Plasma MOL4239 concentration-time data at Days 0 and 28. Blood samples will be collected from 5 subjects on Day 0 (serial blood collections at 0 (pre-dose), 1, 2, 4, and 8 hours post-dose), and Day 28 (serial blood collections at 0 (pre-dose), 1, 2, 4, and 8 hours post-dose]. Individual pharmacokinetic samples will be taken, analyzed, and parameters will be summarized by descriptive statistics at Day 0 and Day 28. The descriptive statistics will include arithmetic mean, standard deviation, median, minimum, maximum, and geometric mean (log-transformed).


Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10% MOL4239 ointment & placebo ointment
10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Drug: MOL4239
10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days
Other Name: MOL4239
Drug: Placebo
placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Other Name: Placebo

Detailed Description:

This is a phase 2a, Randomized, Multi-center, Blinded, Paired Psoriasis Lesion, Comparative Placebo-Controlled study to evaluate the safety, preliminary efficacy and pharmacokinetics of MOL4239 in 30 adult subjects with mild to moderate plaque psoriasis. Eligible subject will have a diagnosis of mild to moderate plaque psoriasis affecting 9.9% body surface area (BSA) or less, and two designated similar target lesions with a Psoriasis Severity Score of at least 6 or higher. Each subject will apply 10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults, males or females, 18 to 72 years of age (both inclusive.)
  • Mild to moderate plaque psoriasis with lesions that in total are no more than 9.9% BSA and with a baseline Psoriasis Severity Score (PSS) of 6 or more.
  • Identification of bilaterally symmetrical or approximately equivalent target lesions of at least 2.5 x 2.5 cm (~6 cm2) on the trunk, arms or legs to mid calf with a Psoriasis Severity Score (PSS) of 6 or greater.
  • Willing to avoid tanning devices or exposure of the treated skin to the sun.
  • Willing to not use cosmetics, including lotions, creams, and moisturizers on the treated lesions.
  • Use of Eucerin® is allowed on all non-test site areas.
  • Willing to forgo systemic and other topical treatments for psoriasis during the course of the study.
  • Willing to avoid bathing or swimming for two hours after study drug treatment.
  • Negative urine pregnancy test at Screening and baseline for women of childbearing potential (WOCP).
  • Sexually active WOCP participating in the study must agree to use a medically acceptable method of contraception while on study.
  • Must have recovered from the effects of any surgery, other than minor office surgical procedures, and a minimum of 3 months must have elapsed from the day of surgery to the day of screening.

Exclusion Criteria:

  • Presence of significant abnormalities of liver or renal functions.
  • Presence of any clinically significant lab abnormalities at screening.
  • Any significant uncontrolled medical disease.
  • Use of the anti-tumor necrosis factor (TNF) biologic agents 4 months prior to randomization or use of Stelara 6 months prior to randomization.
  • Use, within one month prior to baseline or during the study, of: 1) systemic immunosuppressive drugs (e.g., tacrolimus), or 2) oral meds (e.g. methotrexate, retinoids, etc.).
  • Use within one month prior to baseline or during the study of: 1) Systemic corticosteroids, 2) Systemic antibiotics, 3) other systemic antipsoriatic treatment, 4) oral psoralen with ultraviolet A (PUVA) therapy, or 5) ultraviolet B (UVB) therapy.
  • Use within two weeks prior to baseline or during the study of: 1) topical anti-psoriatic drugs, 2) topical corticosteroids, 3) other topical retinoids, or 4) topical immunosuppressive agents.
  • Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis.
  • Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris.
  • Females who are pregnant, breast feeding, or planning a pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826201

Locations
United States, Florida
International Dermatology Research, Inc.
Miami, Florida, United States, 33144
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
Moleculin, LLC
Investigators
Principal Investigator: Eduardo Tschen, MD Academic Dermatology Associates
Principal Investigator: Javier Alonso-Llamazares, MD International Dermatology Research, Inc.
Principal Investigator: Steven Kempers, MD Minnesota Clinical Study Center
  More Information

No publications provided

Responsible Party: Moleculin, LLC
ClinicalTrials.gov Identifier: NCT01826201     History of Changes
Other Study ID Numbers: M-02
Study First Received: March 21, 2013
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Moleculin, LLC:
psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014