Trial to Assess the Potency of SOR007 Ointment in a Psoriasis Plaque Test

NCT03004339 | Completed Phase 1

• 1 other identifier: SOR007-2016-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluation of safety, pharmacokinetics, and anti-psoriatic efficacy to assess SOR007 Ointment in topical formulations

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Change in the thickness of the echolucent band (ELB)

  12 days

Secondary Outcomes (1)

• Evaluation of the antipsoriatic efficacy by clinical assessment using a 5-point score

  12 days

Other Outcomes (2)

• Safety analysis: Summary of Treatment-Emergent Adverse Events

  26 days

• Pharmacokinetic analysis: Maximum Plasma Concentration of Paclitaxel (Cmax)

  12 days

Study Arms (6)

SOR007 Ointment 2.0%

EXPERIMENTAL

Topical application once daily during a 12-day treatment period (10 treatments)

Drug: SOR007 Ointment 2.0%

SOR007 Ointment 1.0%

EXPERIMENTAL

Topical application once daily during a 12-day treatment period (10 treatments)

Drug: SOR007 Ointment 1.0%

SOR007 Ointment 0.3%

EXPERIMENTAL

Topical application once daily during a 12-day treatment period (10 treatments)

Drug: SOR007 Ointment 0.3%

SOR007 Ointment 0.15%

EXPERIMENTAL

Topical application once daily during a 12-day treatment period (10 treatments)

Drug: SOR007 Ointment 0.15%

SOR007 Ointment Placebo

PLACEBO COMPARATOR

Topical application once daily during a 12-day treatment period (10 treatments)

Drug: SOR007 Ointment Placebo

Taclonex® Ointment

ACTIVE COMPARATOR

Topical application once daily during a 12-day treatment period (10 treatments)

Drug: Taclonex® Ointment

Interventions

SOR007 Ointment 2.0% DRUG

SOR007 Ointment 2.0%

SOR007 Ointment 1.0% DRUG

SOR007 Ointment 1.0%

SOR007 Ointment 0.3% DRUG

SOR007 Ointment 0.3%

SOR007 Ointment 0.15% DRUG

SOR007 Ointment 0.15%

SOR007 Ointment Placebo DRUG

SOR007 Ointment Placebo

Taclonex® Ointment DRUG

Also known as: calcipotriene 0.005%/betamethasone dipropionate 0.064%

Taclonex® Ointment

Eligibility Criteria

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

You may qualify if:

• men and surgically sterile or post-menopausal (at least since 12 months amenorrhoea) women aged 18 years or older. The non-childbearing potential of women needs to be confirmed by medical record or in writing by a gynecologist, if that is not possible a follicle stimulating hormone (FSH) test will be performed on female subjects to confirm menopause, unless they are receiving hormonal replacement therapy for treatment of menopause symptoms;
• subjects with psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) with up to three plaque areas sufficient for six treatment fields;
• the target lesion(s) should be on the trunk or extremities (excluding palms/soles); psoriatic lesion on the knees or elbows are not to be used as a target lesion;
• plaques to be treated should have a comparable psoriatic infiltrate thickness of at least 200 μm;
• the physical examination of the skin must be without disease findings other than psoriasis vulgaris unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial;
• male volunteers must agree to sexual abstinence or use adequate contraception when sexually active in combination with their female partners, if they are of childbearing potential. That means the volunteer must be vasectomized or use a condom and his female partner must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, or non-DalKon Shield intra-uterine devices \[IUDs\]. This applies from signing of the informed consent form until 90 days after the last study drug administration. Methods of contraception must have been effective for at least 30 days on the day of signing the informed consent form. Male volunteers must also refrain from sperm donation from signing of the informed consent form until 90 days after the last study drug administration;
• written informed consent obtained.

You may not qualify if:

• pregnancy and nursing;
• other skin disease or condition noted on physical examination that is considered by the investigator to be relevant to the outcome of the trial;
• subjects with acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica and pustular psoriasis;
• any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar, except for salicylic acid and except for treatment on the face, ears and scalp) in the 4 weeks before first treatment and/or during the trial;
• systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids, dimethylfumarate in the three months before first treatment and during the trial;
• systemic treatment with biological treatments: ustekinumab or secukinumab within six months or adalimumab, infliximab and etanercept within three months before first treatment and during the trial;
• UV-therapy within four weeks before first treatment and during the trial;
• treatment with systemic or locally acting medications which might have countered or influenced the trial aim (medications which are known to provoke or aggravate psoriasis, e.g. antimalarial drugs, lithium) within eight weeks before first treatment and/or during the trial. Beta-blockers or angiotensin-converting enzyme (ACE) inhibitors are allowed if on a stable dose for 3 months before study medication initiation;
• intake of Anticoagulant Drugs, e.g. Warfarin, Coumadin. Antiplatelet Drugs e.g. Acetyl salicylic acid are permitted unless considered contraindicated by the investigator for blood withdrawal for PK analyses;
• known allergic reactions, irritations or sensitivity to the active ingredients or other components of the IPs;
• known allergic reactions, irritations or sensitivity to the comparator's active ingredient and/or components;
• contraindications according to summary of product characteristics of the active comparator;
• evidence of drug or alcohol abuse;
• symptoms of a clinically significant illness that may place the subject at risk by trial participation or influence the outcome of the trial in the four weeks before first treatment and during the trial;
• participation in the treatment phase of another clinical trial within the last four weeks prior to first treatment in this clinical trial;

Sponsors & Collaborators

• DFB Soria, LLC: lead
• Bioskin GmbH: collaborator
• US Biotest, Inc.: collaborator

Study Sites (2)

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

Related Publications (17)

• Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013 Feb;133(2):377-85. doi: 10.1038/jid.2012.339. Epub 2012 Sep 27.

  PMID: 23014338 BACKGROUND

• Nestle FO, Di Meglio P, Qin JZ, Nickoloff BJ. Skin immune sentinels in health and disease. Nat Rev Immunol. 2009 Oct;9(10):679-91. doi: 10.1038/nri2622. Epub 2009 Sep 18.

  PMID: 19763149 BACKGROUND

• Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.

  PMID: 19641206 BACKGROUND

• Schiff PB, Horwitz SB. Taxol stabilizes microtubules in mouse fibroblast cells. Proc Natl Acad Sci U S A. 1980 Mar;77(3):1561-5. doi: 10.1073/pnas.77.3.1561.

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• Mirzapoiazova T, Kolosova IA, Moreno L, Sammani S, Garcia JG, Verin AD. Suppression of endotoxin-induced inflammation by taxol. Eur Respir J. 2007 Sep;30(3):429-35. doi: 10.1183/09031936.00154206. Epub 2007 May 30.

  PMID: 17537765 BACKGROUND

• Zhang L, Dermawan K, Jin M, Liu R, Zheng H, Xu L, Zhang Y, Cai Y, Chu Y, Xiong S. Differential impairment of regulatory T cells rather than effector T cells by paclitaxel-based chemotherapy. Clin Immunol. 2008 Nov;129(2):219-29. doi: 10.1016/j.clim.2008.07.013. Epub 2008 Sep 3.

  PMID: 18771959 BACKGROUND

• Belotti D, Vergani V, Drudis T, Borsotti P, Pitelli MR, Viale G, Giavazzi R, Taraboletti G. The microtubule-affecting drug paclitaxel has antiangiogenic activity. Clin Cancer Res. 1996 Nov;2(11):1843-9.

  PMID: 9816139 BACKGROUND

• Ehrlich A, Booher S, Becerra Y, Borris DL, Figg WD, Turner ML, Blauvelt A. Micellar paclitaxel improves severe psoriasis in a prospective phase II pilot study. J Am Acad Dermatol. 2004 Apr;50(4):533-40. doi: 10.1016/j.jaad.2003.09.018.

  PMID: 15034502 BACKGROUND

• Dumas KJ, Scholtz JR. The psoriasis bio-assay for topical corticosteroid activity. Acta Derm Venereol. 1972;52(1):43-8. No abstract available.

  PMID: 4111105 BACKGROUND

• Bangha E, Elsner P. Evaluation of topical antipsoriatic treatment by chromametry, visiometry and 20-MHz ultrasound in the psoriasis plaque test. Skin Pharmacol. 1996;9(5):298-306. doi: 10.1159/000211428.

  PMID: 8990504 BACKGROUND

• Kvist PH, Svensson L, Hagberg O, Hoffmann V, Kemp K, Ropke MA. Comparison of the effects of vitamin D products in a psoriasis plaque test and a murine psoriasis xenograft model. J Transl Med. 2009 Dec 17;7:107. doi: 10.1186/1479-5876-7-107.

  PMID: 20017943 BACKGROUND

• Kragballe K, Noerrelund KL, Lui H, Ortonne JP, Wozel G, Uurasmaa T, Fleming C, Estebaranz JL, Hanssen LI, Persson LM. Efficacy of once-daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris. Br J Dermatol. 2004 Jun;150(6):1167-73. doi: 10.1111/j.1365-2133.2004.05986.x.

  PMID: 15214905 BACKGROUND

• Kaufmann R, Bibby AJ, Bissonnette R, Cambazard F, Chu AC, Decroix J, Douglas WS, Lowson D, Mascaro JM, Murphy GM, Stymne B. A new calcipotriol/betamethasone dipropionate formulation (Daivobet) is an effective once-daily treatment for psoriasis vulgaris. Dermatology. 2002;205(4):389-93. doi: 10.1159/000066440.

  PMID: 12444337 BACKGROUND

• Reich K, Bewley A. What is new in topical therapy for psoriasis? J Eur Acad Dermatol Venereol. 2011 Jun;25 Suppl 4:15-20. doi: 10.1111/j.1468-3083.2011.04061.x.

  PMID: 21507079 BACKGROUND

• Schmid-Ott G, Kunsebeck HW, Jager B, Sittig U, Hofste N, Ott R, Malewski P, Lamprecht F. Significance of the stigmatization experience of psoriasis patients: a 1-year follow-up of the illness and its psychosocial consequences in men and women. Acta Derm Venereol. 2005;85(1):27-32. doi: 10.1080/000155550410021583.

  PMID: 15848987 BACKGROUND

• Gupta MA, Gupta AK. Age and gender differences in the impact of psoriasis on quality of life. Int J Dermatol. 1995 Oct;34(10):700-3. doi: 10.1111/j.1365-4362.1995.tb04656.x.

  PMID: 8537157 BACKGROUND

• Remitz A, Reitamo S, Erkko P, Granlund H, Lauerma AI. Tacrolimus ointment improves psoriasis in a microplaque assay. Br J Dermatol. 1999 Jul;141(1):103-7. doi: 10.1046/j.1365-2133.1999.02927.x.

  PMID: 10417522 BACKGROUND

MeSH Terms

Interventions

calcipotriene

Study Officials

• Gere S diZerega, MD

  US Biotest, Inc./DFB Soria, LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: December 20, 2016
• First Posted: December 28, 2016
• Study Start: August 1, 2016
• Primary Completion: February 13, 2017
• Study Completion: February 13, 2017
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)