Mild to moderate psoriasis MedDRA version: 14.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: UCB4940
Product Code: UCB4940
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not available
CAS Number: Not availabl
Current Sponsor code: UCB4940
Other descriptive name:
Sponsors
UCB Celltech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 ;Inclusion criteria: 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 ;Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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;Exclusion criteria: 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 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;Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.;Secondary Objective: 1. PK of single ascending doses of UCB4940 administered by iv infusion. 2. Effect of single doses of UCB4940 on clinical features of plaque psoriasis.;Primary end point(s): Safety parameters that will be assessed: adverse events, vital signs including BP measurements, ECG data, and clinical laboratory tests. ;Timepoint(s) of evaluation of this end point: The assessments will be made at various timepoints from screnning through to the safety follow up visit.;Main Objective: To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.;Secondary Objective: 1. PK of single ascending doses of UCB4940 administered by iv infusion. 2. Effect of single doses of UCB4940 on clinical features of plaque psoriasis.;Primary end point(s): Safety parameters that will be assessed: adverse events, vital signs including BP measurements, ECG data, and clinical laboratory tests. ;Timepoint(s) of evaluation of this end point: The assessments will be made at various timepoints from screnning through to the safety follow up visit.;Main Objective: To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.;Secondary Objective: 1. PK of single ascending doses of UCB4940 administered by iv infusion. 2. Effect of single doses of UCB4940 on clinical features of plaque psoriasis.;Primary end point(s): Safety parameters that will be assessed: adverse events, vital signs including BP measurements, ECG data, and clinical laboratory tests. ;Timepoint(s) of evaluation of this end point: The assessments will be made at various timepoints from screnning through to the safety follow up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetic parameters that will be determined from plasma: Cmax, AUC0-8, AUC0-t, tmax, t1/2, ?z,CL, and Vz. Pharmacodynamic parameters that will be evaluated: the effect of UCB4940 on psoriatic plaques using the LSS, thickness of the plaque (measured in mm) and keratinocyte layer depth, lesion area, and the overall disease severity using the PGA and the PASI. ;Timepoint(s) of evaluation of this end point: The assessments will be made at various timepoints from screnning through to the safety follow up visit.;Secondary end point(s): Pharmacokinetic parameters that will be determined from plasma: Cmax, AUC0-8, AUC0-t, tmax, t1/2, ?z,CL, and Vz. Pharmacodynamic parameters that will be evaluated: the effect of UCB4940 on psoriatic plaques using the LSS, thickness of the plaque (measured in mm) and keratinocyte layer depth, lesion area, and the overall disease severity using the PGA and the PASI. ;Timepoint(s) of evaluation of this end point: The assessments will be made at various timepoints from screnning through to the safety follow up visit.;Secondary end point(s): Pharmacokinetic parameters that will be determined from plasma: Cmax, AUC0-8, AUC0-t, tmax, t1/2, ?z,CL, and Vz. Pharmacodynamic parameters that will be evaluated: the effect of UCB4940 on psoriatic plaques using the LSS, thickness of the plaque (measured in mm) and keratinocyte layer depth, lesion area, and the overall disease severity using the PGA and the PASI. ;Timepoint(s) of evaluation of this end point: The assessments will be made at various timepoints from screnning through to the safety follow up visit. | — |
Countries
United Kingdom
Contacts
Public ContactCT Registries & Result Disclosure;CT Registries & Result Disclosure;CT Registries & Result Disclosure ;;
UCB BIOSCIENCES GmbH;UCB BIOSCIENCES GmbH;UCB BIOSCIENCES GmbH
Outcome results
None listed