Safety and Efficacy Study of Etanercept (Qiangke®) to Treat Moderate to Severe Plaque Psoriasis

NCT02701205 | Unknown Phase 3

• 1 other identifier: QRSTPP
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 4

Brief Summary

This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) in the treatment of Moderate to Severe Plaque Psoriasis. The primary purpose is to assess the different maintaining treatment programme in Moderate to Severe plaque psoriasis by Qiangke®. And the second purpose is to assess the efficacy and safety of Qiangke® in Moderate to Severe Plaque Psoriasis. The trial will include 216 Moderate to Severe plaque psoriasis patients,and at the first stage they will be randomized divided into three group: full-dose of Qiangke® group, half-dose of Qiangke® group and placebo group.And the blind stage will last for 12 weeks. Then at the second stage, all patients will receive 50mg qw of Qiangke® for additional 12 weeks.

Conditions

Plaque Psoriasis; Psoriasis

Keywords

Plaque Psoriasis; Skin Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12

  Week 12

Secondary Outcomes (6)

• Proportion of subjects achieving PASI 90 & 50

  Week 12

• Proportion of subjects achieving PASI 90 & 50 & 75

  Week 24

• Physician's Global Assessment (PGA)

  Week 12 & 24

• Nail Psoriasis Severity Index (NAPSI)

  Week 12 & 24

• Dermatology Life Quality Index (DLQI)

  Week 12 & 24

Other Outcomes (1)

• Safety parameters - Number of Participants With Abnormal Laboratory Values and/or Adverse Events

  Week 12 & 24

Study Arms (3)

etanercept

EXPERIMENTAL

Recombinant Human TNF Receptor-Ig Fusion Protein for Injection（Qiangke®) 50mg twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week from Week 12 to Week 24

Biological: etanercept

etanercept (half dose)

EXPERIMENTAL

One vial of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection（Qiangke®） 25mg and one vial of placebo twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week from Week 12 to Week 24

Biological: etanercept (half dose)

Placebo

PLACEBO COMPARATOR

Two vials of Placebo twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection（Qiangke®) 25mg twice a week from Week 12 to Week 24

Drug: placebo

Interventions

etanercept BIOLOGICAL

Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.

Also known as: Qiangke®

etanercept

etanercept (half dose) BIOLOGICAL

Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.

Also known as: Qiangke®

etanercept (half dose)

placebo DRUG

two vials of placebo twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or Female, age 18-65,Asian.
• Freely provides both verbal and written informed consent.
• Consent to use effective contraception during the trial period.
• Participant had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
• Participant must have a Psoriasis Area Severity Index score greater than or equal to 12 at the baseline visit and Body Surface Area involvement greater than or equal to 10% at the baseline visit.
• Participant has previous exposure to systemic psoriasis therapy or phototherapy, but not ideal.
• Meet the following criteria for Tuberculosis screening: A. has no prior history of occult or active tuberculosis. B. No signs or symptoms of active tuberculosis in history and / or physical examination. C. in the first 6 weeks of the trial, tuberculosis screening test meet the requirements of the trial.
• Laboratory screening results:Hemoglobin≥110g/L.White blood cell≥4 \* 109 /L. Neutrophil≥1.5 \* 109/L.Platelet≥100 \* 109/L.Serum alanine aminotransferase and / or aspartate aminotransferase not more than 1.5 times of the upper limit of normal.Serum creatinine does not exceed 1.5 mg/dL (International units: ≤133 mol/L).
• During the first 2 weeks of the study, Participant must stop adjuvant therapy including traditional Chinese medicine and acupuncture.
• Hepatitis B (HBV) screening in compliance with the requirements of this test.
• Weight≥60Kg.

You may not qualify if:

• Pustular, erythrodermic, and/or guttate forms of psoriasis.
• Participant had treated with TNF antagonists within 6 weeks prior to the Baseline visit.
• Participant had treated with Other biological agents within 6 weeks prior to the Baseline visit.
• Participant had treated with Phototherapy or systemic antipsoriatic treatment (such as:Methotrexate（MTX）， acitretin, cyclosporine, Total Glucosides of Paeony（TGP）, treatment of psoriasis related Chinese medicines, etc.) and systemic corticosteroid treatment within 4 weeks prior to the Baseline visit.
• Participant had treated with Topical corticosteroid therapy, vitamin A or D analogue or Anthralin within 2 weeks prior to the Baseline visit.
• Participant received any drug that the drug's metabolism was less than 7 half lives before the Baseline visit.
• Participant plans to pregnant or breast feeding or father during the study.
• The history of occult or active granuloma infections, including histoplasmosis, coccidioidomycosis.
• Participant has suffered from Non Mycobacterium tuberculosis infection or opportunistic infections (such as cytomegalovirus sense of dyeing, Pneumocystis carinii pneumonia, aspergillosis) within 6 weeks prior to the Baseline visit.
• The close contact history of active tuberculosis patients or Tuberculosis screening results do not meet the requirements.
• Participant has suffered from severe infection (for example hepatitis, pneumonia, acute pyelonephritis or sepsis), or participant use intravenous antibiotics now because of infection within 6 weeks prior to the Baseline visit.
• Participant has suffered from chronic or recurrent infections before or at present, including (but not limited to) chronic kidney infection disease and chronic chest infectious diseases (such as bronchial dilation), sinusitis, recurrent urinary tract infections (such as recurrent pyelonephritis and chronic non remission cystitis), open, overflow liquid or infection of skin wound or ulcer.
• Human immunodeficiency virus (HIV) antibody positive.
• Hepatitis B virus (HBV) screening results do not meet the requirements.
• Hepatitis C virus (HCV) antibody positive.

Sponsors & Collaborators

• Shanghai Celgen Bio-Pharmaceutical Co.,Ltd: lead

Study Sites (4)

Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

RECRUITING

Institute of Dermatology and Skin Disease Hospital Chinese Academy of Medical Sciences

Nanjing, Jiangsu, 210042, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Changhai Hospital of The Second Military Medical University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (8)

• Gottlieb AB, Chamian F, Masud S, Cardinale I, Abello MV, Lowes MA, Chen F, Magliocco M, Krueger JG. TNF inhibition rapidly down-regulates multiple proinflammatory pathways in psoriasis plaques. J Immunol. 2005 Aug 15;175(4):2721-9. doi: 10.4049/jimmunol.175.4.2721.

  PMID: 16081850 BACKGROUND

• Gudjonsson JE, Elder JT. Psoriasis: epidemiology. Clin Dermatol. 2007 Nov-Dec;25(6):535-46. doi: 10.1016/j.clindermatol.2007.08.007.

  PMID: 18021890 BACKGROUND

• Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol. 1998 Nov;139(5):846-50. doi: 10.1046/j.1365-2133.1998.02511.x.

  PMID: 9892952 BACKGROUND

• Leonardi CL, Powers JL, Matheson RT, Goffe BS, Zitnik R, Wang A, Gottlieb AB; Etanercept Psoriasis Study Group. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003 Nov 20;349(21):2014-22. doi: 10.1056/NEJMoa030409.

  PMID: 14627786 RESULT

• Kivelevitch D, Mansouri B, Menter A. Long term efficacy and safety of etanercept in the treatment of psoriasis and psoriatic arthritis. Biologics. 2014 Apr 17;8:169-82. doi: 10.2147/BTT.S41481. eCollection 2014.

  PMID: 24790410 RESULT

• Papp KA, Tyring S, Lahfa M, Prinz J, Griffiths CE, Nakanishi AM, Zitnik R, van de Kerkhof PC, Melvin L; Etanercept Psoriasis Study Group. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005 Jun;152(6):1304-12. doi: 10.1111/j.1365-2133.2005.06688.x.

  PMID: 15948997 RESULT

• Sterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, Estojak J, Molta CT, Freundlich B. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010 Feb 2;340:c147. doi: 10.1136/bmj.c147.

  PMID: 20124563 RESULT

• Chiu HY, Wang TS, Cho YT, Tsai TF. Etanercept use for psoriasis in Taiwan: a case series study. Int J Dermatol. 2013 Jun;52(6):673-80. doi: 10.1111/j.1365-4632.2011.05273.x. Epub 2012 Feb 20.

  PMID: 22348620 RESULT

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Hongzhong Jin, M.D.

  Chinese Academy of Medical Sciences Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongzhong Jin, M.D.

CONTACT

8613693583080; jinhongzhong@263.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2016
• First Posted: March 8, 2016
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

CN (4)