A study to investigate what effects FX125L (taken by mouth) has on adults with chronic inflammatory diseases

• Conditions: AsthmaChronic obstructive pulmonary diseaseRheumatoid arthritisPsoriasis; MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-005036-26-GB
• Lead Sponsor: Funxional Therapeutics Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-31
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Willing and able to give written informed consent and to comply with the requirements of the study.
2.Male or female aged 18–77 years, inclusive.
3.Body mass index 18–35 kg/m2, inclusive.
4.Females of child-bearing potential must be using an adequate and medically acceptable contraception method.
5.Females of child-bearing potential must not be lactating or pregnant (negative serum beta-human chorionic gonadotropin on Screening or urine pregnancy test at Day -1 visit).
6.Male patients must agree not to donate sperm, and to take appropriate precautions to avoid fathering a child, throughout the study and until 90 days after the end of treatment.
7.Ability to produce an analysable sample of sputum at Screening. This is defined as a) a sputum plug with a weight exceeding 500 mg and b) more than 300 intact leukocytes on a cytospin slide.

In addition, patients must meet the inclusion criteria for a chronic inflammatory disease as follows:

Asthma:
1.Documented diagnosis of asthma at least 6 months prior to Screening or equivalent that confirms the diagnosis meets this criteria
2.Forced expiratory volume in 1 second =60% and =90% of predicted at Screening and Randomisation (Day -1).
3.Sputum eosinophilia =3% at Screening.

Chronic Obstructive Pulmonary Disorder:
1.Documented diagnosis of moderate to severe COPD, according to Global Initiative for Chronic Obstructive Lung Disease criteria, at least 6 months prior to the screening visit, and who meet the criteria for Stage II–III disease at Screening , and who meet the criteria for Stage II–III disease at Screening.
2.Stable disease for at least 1 month prior to Screening.
3.Sputum neutrophils = 40% at Screening.

Rheumatoid Arthritis:
1.Documented diagnosis of rheumatoid arthritis according to the 1996 American College or Rheumatology (ACR) / European League Against Rheumatism criteria.
2.Global functional class I, II or III according to the ACR 1991 revised criteria at Screening and Day -1.
3.At least six swollen joints and at least six tender joints during the 28-joint assessment performed at Screening and Day -1.
4.C-reactive protein =7.0 mg/L at Screening.
5.Presence of anti-cyclic citrullinated peptide antibodies >50 ELISA Units (or above the median titre among RA patients for the anti-cyclic citrullinated peptide assay used at the clinical site) at Screening.

Psoriasis
1.Documented diagnosis of moderate/severe chronic plaque psoriasis for more than 6 months, and eligible for systemic treatment , or equivalent that confirms the diagnosis meets this criteria.
2.Plaque psoriasis covering greater than 5% of total body surface area and a Psoriasis Area and Severity Index score of 12.0 or more at Screening and Day -1.
3.At least one evaluable plaque psoriasis lesion with a Psoriatic Lesion Severity Sum total score (erythema, induration and scaling) of 5–12 and an induration score of 2–4 at Screening and Day -1.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 119
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 119

Exclusion Criteria

1.Any condition, including findings in the medical history or in the pre-study assessments, which, in the opinion of the Investigator, constitute a risk or contraindication for the participation of the subject in the study, or that could interfere with the study objectives, conduct, or evaluation including, but not limited to:
-Any clinically significant abnormality in the results of screening safety laboratory tests.
-Positive test for drugs of abuse.
-Positive alcohol breath test.
-Positive results from serum tests for hepatitis B surface antigen (except if due to vaccination), hepatitis C, or HIV.
-History or presence of liver disease.
-History or presence of endocrine disorders or diseases affecting the hypothalamic-pituitary-adrenal axis, including acromegaly, growth hormone deficiency, adrenal insufficiency, Cushing’s syndrome, Grave’s Disease, Hashimoto’s Disease, uncontrolled diabetes mellitus, with the exception of idiopathic hypothyroidism in patients > 60 years.
-History of hypofertility.
-History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin and squamous cell carcinoma in situ of the skin)
2.History or presence of drug or alcohol abuse.
3.History or active manifestation of a serious psychiatric illness including depression, suicidal ideation or psychosis.
4.Positive test for latent tuberculosis.
5.Requirement for immunisations or vaccinations within 7 days of any visit during the entire study period (including the screening, treatment and follow-up phases).
6.Previous participation in the current study, or administration of any investigational product within 12 weeks (or at least 5 times the half-life of the product, if longer) prior to entry into the study.
7.Acute infection requiring a visit to a doctor or hospital, or treatment with a prescription-only medication, within 2 weeks prior to Day 1.
8.Any condition that may affect the absorption of an orally administered drug, for example, but not limited to, ulcerative colitis or resection of the stomach or small bowel.
9.Required to take a proscribed drug during the study.
10.History of treatment with corticosteroids, whether systemic, topical or inhaled, within 1 month of screening.
11.History of treatment with a biological anti-inflammatory therapy within 6 months of screening.
12.History of exposure to FX125L.

Patients must not meet any exclusion criteria for at least 1 of the chronic inflammatory disease(s) for which they met the disease-specific inclusion criteria:

Asthma:
1.Received treatment with topical or oral asthma or allergy medications except ß-agonists within 4 weeks prior to Screening.
2.Suffer from respiratory diseases, other than asthma or allergic rhinitis, which would interfere with asthma disease assessments.
3.Respiratory infections within 8 weeks prior to Day 1.
4.Asthma exacerbation leading to hospitalisation for >2 days within the last 6 months or a hospital accident and emergency visit due to asthma exacerbation in the last 3 months.

COPD:
1.Exacerbation of COPD requiring treatment with oral steroids or hospitalisation within 3 months prior to screening, or >2 such exacerbations with the 6 months prior to screening.
2.Suffer from respiratory diseases other than COPD that would interfere with COPD disease assessments.
3.Evidence of cor pulmonale, clinically significant pulmonary hypertension or chronic use of oxygen.
4.History of lung resection or lung reduction surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified