A randomized, placebo-controlled, double-blind, multicentre, multiple dose, cohort study with escalating doses to evaluate the safety and efficacy of the humanized monoclonal antibody (mab) BT061 administered subcutaneously or intravenously as 8 repeated doses to patients with moderate to severe chronic plaque psoriasis.

Phase 1

• Conditions: patients with moderate to severe chronic plaque psoriasis; MedDRA version: 12.0Level: LLTClassification code 10037153Term: Psoriasis; MedDRA version: 12.0Level: PTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2008-007458-37-HU
• Lead Sponsor: Biotest AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-22
• Study Completion: 2011-05-23
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

To participate in this trial, patients must meet all the following criteria:

1. Male and female patients with moderate, moderate to severe or severe chronic plaque psoriasis diagnosed = 12 months prior to Screening.
2. BSA involvement > 10% for more than 6 months.
3. PASI = 10.
4. Age = 18 to = 75 years.
5. Body mass index (BMI) of 18–30 kg/m2 with a body weight between 50 and 130 kg.
6. Patient on any medication prescribed for another indication must be at stable dose for at least 14 days prior to the administration of BT061 or placebo.
7. Cluster of differentiation 4 (CD4) cell count at Screening Visit is = 75% the lower limit of normal.
8. B cell count at Screening Visit is = 75% the lower limit of normal.
9. Written informed consent (signed and dated by patient).
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Erythrodermic, guttate or palmar pustular psoriasis
a. Mixed forms of plaque psoriasis (psoriasis vulgaris) with palmar pustular psoriasis, such as psoriasis vulgaris cum pustulatione, are allowed as long as psoriasis vulgaris is the predominant form.
b. Patients with a history of psoriasis guttata are admitted as long as psoriasis vulgaris is the predominant diagnosis at the time of inclusion
c. Patients with ongoing psoriasis guttata cannot be enrolled.
2. Treatment with a biological within less than 30 days or within less than 5 half-lives of the respective compound prior to administration of BT061/placebo. Compounds where 5 half-lives exceed 30 days have therefore to be washed out for at least 5 half-lives.
3. Treatment with systemic retinoids, corticosteroids and immunosuppressants within 4 weeks prior to the administration of BT061 or placebo.
4. Any other systemic psoriasis relevant treatment (hydroxychloroquine, chloroquine, lithium) within 4 weeks prior to the administration of BT061 or placebo.
5. High potency topical treatments (corticosteroids, keratolytics, coal tar) within 2 weeks prior to the administration of BT061 or placebo.
6. Psoralen and Ultraviolet A (PUVA) therapy within 4 weeks prior to the administration of BT061 or placebo.
7. Ultraviolet B (UVB) therapy within 2 weeks prior to the administration of BT061 or placebo.
8. Recent holiday (within the last 2 weeks) with greater than usual sun exposure or plans to go on such a holiday before Final Follow-up visit.
9. Treatment with leflunomide within 8 weeks prior to the administration of BT061 or placebo (except specific wash out procedure, i. e. 11 days with colestyramine or activated charcoal plus 30 days wash-out).
10. Clinically relevant abnormalities regarding haematocrit, haemoglobin or platelets, serum concentration of creatinine or bilirubin, or in complete cell count and differential cell count.
11. Kidney insufficiency as defined by creatinine clearance: < 60 ml/min (Cockcroft Gault equation).
12. Alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) = 3 times the upper limit of normal.
13. History of clinically significant major disease i.e., severe heart/ lung diseases New York Heart Association (NYHA) ? 3 (class III: patients with marked limitation of activity; comfortable only at rest).
14. Acute or clinically relevant abnormalities in electrocardiogram (ECG).
15. History of malignancy during 5 years prior to Screening visit (except squamous or basal cell carcinoma of the skin).
16. Serious local (e.g. abscess) or systemic infection (e.g. pneumonia, septicaemia) within 3 months prior to the administration of BT061 or placebo.
17. Presence or history of clinically significant immune deficiency or autoimmune disease (except psoriasis).
18. Presence or history of severe uncontrolled allergies or anaphylactic reactions.
19. Presence of severe uncontrolled hypertension or hypotension.
20. Presence of acute uncontrolled hypothyroidism or hyperthyroidism.
21. Positive diagnosis of latent or active tuberculosis.
22. Positive diagnosis for acute or chronic infections (i.e. Hepatitis C Virus [HCV], Hepatitis B Virus [HBV], Human Immunodeficiency Virus [HIV]) at Screening visit.
23. Positive cytomegalovirus (CMV) viral load in serum at Screening visit.
24. Positive Epstein-Barr Virus (EBV) immunoglobulin class M (IgM) titre or EBV viraemia at Screening visit. Patients with a positive polymerase chain reaction (PCR) result in lymphocyte de

Study & Design

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