A study to assess the safety, pharmacokinetics (the way thebody absorbs, distributes and eliminates the drug) and pharmacodynamics (effects of drug on the body) of UCB4940 in patients with psoriasis.
- Conditions
- Mild to moderate psoriasisMedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2012-002086-35-GB
- Lead Sponsor
- CB Celltech
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 39
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject prior to the initiation of any study-specific assessment at Screening.
2. Subject is considered reliable and capable of adhering to the protocol, according to the judgment of the Investigator, and has adequate reading and writing abilities (in his/her native
language) such that the subject can comprehend and answer the questions on the subject-completed assessments.
3. Subject is male or female, aged =18 years to =70 years at Screening. Female subjects must either be postmenopausal (at least 1 year), permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential, must be willing to use at least 2 effective methods of contraception, including a barrier method (eg, male condom,
female condom, or diaphragm with spermicide) during the study period. Effective methods of contraception are methods of birth control, which result in a low failure rate when used consistently and correctly, such as implants, injectables, oral contraceptives,
progesterone-releasing intrauterine systems or the TCu 380A intrauterine device, complete sexual abstinence, or vasectomized partner (where post vasectomy testing has demonstrated
sperm clearance). Male subjects with partners of childbearing potential must be willing to use a condom when sexually active. Both male and female subjects must use the above mentioned contraception for 20 weeks after administration of study drug (anticipated 5 half-lives).
4. Subject has had a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving =5% of BSA (excluding the scalp).
5. Subject has a body mass index of =35kg/m2 at Screening.
6. Subject has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy.
7. Subject has adequate venous access on inspection.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
;
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject prior to the initiation of any study-specific assessment at Screening.
2. Subject is considered reliable and capable of adhering to the protocol, according to the judgment of the Investigator, and has adequate reading and writing abilities (in his/her native
language) such that the subject can comprehend and answer the questions on the subject-completed assessments.
3. Subject is male or female, aged =18 years to =70 years at Screening. Female subjects must either be postmenopausal (at least 1 year), permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential, must be willing to use at least 2 effective methods of contraception, including a barrier method (eg, male condom,
female condom, or diaphragm with spermicide) during the study period. Effective methods of contraception are methods of birth control, which result in a low failure rate when used consistently and correctly, such as implants, injectables, oral contraceptives,
progesterone-releasing intrauterine systems or the TCu 380A intrauterine device, complete sexual abstinence, or vasectomized partner (where post vasectomy testing has demonstrated
sperm clearance). Male subjects with partners of childbearing potential must be willing to use a condom when sexually active. Both male and female subjects must use the above mentioned contraception for 20 weeks after administration of study drug (anticipated 5 half-lives).
4. Subject has had a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving =5% of BSA (excluding the scalp).
5. Subject has a body mass index of =35kg/m2 at Screening.
6. Subject has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy.
7. Subject has adequate venous access on inspection.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
;
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject prior to the initiation of any study-specific assessment at Screening.
2. Subject is considered reliable and capable of adhering to the protocol, according to the judgment of the Investigator, and has adequate reading and writing abilities (in his/her native
language) such that the subject can comprehend and answer the questions on the subject-completed assessments.
3. Subject is male or female, aged =18 years to =70 years at Screening. Female subjects must either be postmenopausal (at least 1 year), permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential, must be willing to use at least 2 effective methods of contraception, including a barrier method (eg, male condom,
female condom, or diaphragm with spermicide) during the study period. Effective methods of contraception are methods of birth control, which result in a low failure rate when used consistently and correctly, such as implants, injectables, oral contraceptives,
progesterone-releasing intrauterine systems or the TCu 380A intrauterine device, complete sexual abstinence, or vasectomized partner (where post vasectomy testing has demonstrated
sperm clearance). Male subjects with partners of childbearing potential must be willing to use a condom when sexually active. Both male and female subjects must use the above mentioned contraception for 20 weeks after administration of study drug (anticipated 5 half-lives).
4. Subject has had a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving =5% of BSA (excluding the scalp).
5. Subject has a body mass index of =35kg/m2 at Screening.
6. Subject has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy.
7. Subject has adequate venous access on inspection.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
1. Subject has a personal history of polysorbate 80, sorbitol, and/or fructose intolerance.
2. Subject has donated more than 400mL of blood or blood products within 90 days prior to check-in (Day -2) or plans to donate blood during the study.
3. Subject is legally institutionalized or has a mental health condition or related care provision (eg, guardianship) that would impede the subject from providing voluntary informed consent to participate in the study.
4. Subject is an employee or direct relative of an employee of PAREXEL or UCB.
5. Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method.
Exclusion criteria related to drugs:
6. Subject has received systemic nonbiologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening.
7. Subject has received treatment with biologic agents within 12 months prior to the study.
8. Subject has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study.
9. Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to IMP administration.
10. Subject has a history of drug allergy or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates his/her participation.
11. Subject requires treatment with a nonsteroidal anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic.
Exclusion criteria related to concomitant diseases:
12. Subject has a current or past history of gastrointestinal ulceration.
13. Subject has cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, stroke, peripheral arterial disease sufficient to cause symptoms and/or require therapy to maintain stable status.
14. Subject has diabetes mellitus of any type requiring insulin.
15. Subject has unstable/poorly-controlled Type 2 diabetes mellitus, defined as a glycosylated hemoglobin type A1c (HbA1c) level =8.5%.
16. Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration. When in doubt, the Investigator should confer with the UCB Study Physician.
17. Subject has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening that cannot be attributed to a prior Bacillus Calmette-Guérin
inoculation.
18. Subject has a positive hepatitis B surface antigen or positive hepatitis C antibody result within 3 months prior to Screening.
19. Subject has a positive test for human immunodeficiency virus (HIV) antibody.
20. Subject has any of the following hematology values at Screening:
- For women, hemoglobin <11g/dL; for men, <13g/dL
- ANC <1.5x109/L (<1500/µL)
21. Subject has 12-lead ECG with changes considered to be clinically significant, eg, QTc >450ms, bundle branch block, evidence of myocardial ischemia.
22. Subject has renal or liver impairment, defined as:
- For women, serum creatinine level =125µmol/L; for men, =135µmol/L, or
- ALT and as;
1. Subject has a personal history of polysorbate 80, sorbitol, and/or fructose intolerance.
2. Subject has donated more than 400mL of blood or blood products within 90 days prior to check-in (Day -2) or plans to donate blood during the study.
3. Subject is legally institutionalized or has a mental health condition or related care provision (eg, guardianship) that would impede the subject from providing voluntary informed consent to participate in the study.
4. Subject is an employee or direct relative of an employee of PAREXEL or UCB.
5. Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method.
Exclusion criteria related to drugs:
6. Subject has received systemic nonbiologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening.
7. Subject has received treatment with biologic agents within 12 months prior to the study.
8. Subject has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study.
9. Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to IMP administration.
10. Subject has a history of drug allergy or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates his/her participation.
11. Subject requires treatment with a nonsteroidal anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic.
Exclusion criteria related to concomitant diseases:
12. Subject has a current or past history of gastrointestinal ulceration.
13. Subject has cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, stroke, peripheral arterial disease sufficient to cause symptoms and/or require therapy to maintain stable status.
14. Subject has diabetes mellitus of any type requiring insulin.
15. Subject has unstable/poorly-controlled Type 2 diabetes mellitus, defined as a glycosylated hemoglobin type A1c (HbA1c) level =8.5%.
16. Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration. When in doubt, the Investigator should confer with the UCB Study Physician.
17. Subject has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening that cannot be attributed to a prior Bacillus Calmette-Guérin
inoculation.
18. Subject has a positive hepatitis B surface antigen or positive hepatitis C antibody result within 3 months prior to Screening.
19. Subject has a positive test for human immunodeficiency virus (HIV) antibody.
20. Subject has any of the following hematology values at Screening:
- For women, hemoglobin <11g/dL; for men, <13g/dL
- ANC <1.5x109/L (<1500/µL)
21. Subject has 12-lead ECG with changes considered to be clinically significant, eg, QTc >450ms, bundle branch block, evidence of myocardial ischemia.
22. Subject has renal or liver impairment, defined as:
- For women, serum creatinine level =125µmol/L; for men, =135µmol/L, or
- ALT and as;
1. Subject has a personal history of polysorbate 80, sorbitol, and/or fructose intolerance.
2. Subject has donated more than 400mL of blood or blood products within 90 days prior to check-in (Day -2) or plans to donate blood during the study.
3. Subject is legally institutionalized or has a mental health condition or related care provision (eg, guardianship) that would impede the subject from providing voluntary informed consent to participate in the study.
4. Subject is an employee or direct relative of an employee of PAREXEL or UCB.
5. Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method.
Exclusion criteria related to drugs:
6. Subject has received systemic nonbiologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening.
7. Subject has received treatment with biologic agents within 12 months prior to the study.
8. Subject has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study.
9. Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to IMP administration.
10. Subject has a history of drug allergy or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates his/her participation.
11. Subject requires treatment with a nonsteroidal anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic.
Exclusion criteria related to concomitant diseases:
12. Subject has a current or past history of gastrointestinal ulceration.
13. Subject has cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, stroke, peripheral arterial disease sufficient to cause symptoms and/or require therapy to maintain stable status.
14. Subject has diabetes mellitus of any type requiring insulin.
15. Subject has unstable/poorly-controlled Type 2 diabetes mellitus, defined as a glycosylated hemoglobin type A1c (HbA1c) level =8.5%.
16. Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration. When in doubt, the Investigator should confer with the UCB Study Physician.
17. Subject has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening that cannot be attributed to a prior Bacillus Calmette-Guérin
inoculation.
18. Subject has a positive hepatitis B surface antigen or positive hepatitis C antibody result within 3 months prior to Screening.
19. Subject has a positive test for human immunodeficiency virus (HIV) antibody.
20. Subject has any of the following hematology values at Screening:
- For women, hemoglobin <11g/dL; for men, <13g/dL
- ANC <1.5x109/L (<1500/µL)
21. Subject has 12-lead ECG with changes considered to be clinically significant, eg, QTc >450ms, bundle branch block, evidence of myocardial ischemia.
22. Subject has renal or liver impairment, defined as:
- For women, serum creatinine level =125µmol/L; for men, =135µmol/L, or
- ALT and as
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method