A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03073213
• Collaborator: (none)
• Enrollment: 32
• Locations: 3
• Arms: 3
• Actual Duration (Months): 25
• Patients Per Site: 10.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of the study is to research how much ixekizumab enters the bloodstream and how long the body takes to get rid of the drug and the safety of ixekizumab and any side effects that might be associated with it. The study has two parts: A single-dose part and multiple-dose part. The single dose part of this study will last up to 24 weeks, including the screening period. The multiple dose part of this study will last up to 32 weeks including the screening period.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: Ixekizumab	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Single- and Multiple-Dose Study to Assess the Safety and Pharmacokinetics of Ixekizumab (LY2439821) (Anti-IL-17 Humanized Antibody) in Chinese Patients With Psoriasis Vulgaris
• Actual Study Start Date: Apr 13, 2017
• Actual Primary Completion Date: May 14, 2019
• Actual Study Completion Date: May 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ixekizumab single dose Participants received single dose of 80mg Ixekizumab by subcutaneous injection.	Drug: Ixekizumab; Administered as subcutaneous (SC) injection; Other Names: LY2439821
Experimental: Ixekizumab Multiple Regimen 1 (80mg Q2W) Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.	Drug: Ixekizumab; Administered as subcutaneous (SC) injection; Other Names: LY2439821
Experimental: Ixekizumab Multiple Regimen 2 (80mg Q4W) Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.	Drug: Ixekizumab; Administered as subcutaneous (SC) injection; Other Names: LY2439821

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose) [Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141]

   Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.

2. Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose) [Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141]

   Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.

3. Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose) [day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197]

   Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.

4. Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose) [day 57 (Pre-dose), 59, 61, 64, 67, 71]

   Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose).

5. Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose) [day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85]

   Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males or females aged ≥18 years.

• Diagnosis of chronic plaque psoriasis for ≥6 months before baseline.

• Candidates for phototherapy and/or systemic therapy.

• ≥10% body surface area (BSA) involvement at screening and baseline.

• static Physician's Global Assessment (sPGA) score ≥3, and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline.

Exclusion Criteria:

• Clinically significant flare of psoriasis during the 12 weeks before baseline.

• Systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to baseline .

• Current or recent use of any biologic agent within the required washout periods.

• Clinical evidence or suspicion of active tuberculosis or previously had evidence of active tuberculosis and did not receive appropriate and documented treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiangya Hospital, Central South University	Changsha	Hunan	China
2	Second Affiliate Hospital of Zhejiang Medical University	Hangzhou	Zhejiang	China	310009
3	Ruijin Hospital Affiliated to Shanghai Jiao Tong University	Shanghai		China	200025

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

• Study Protocol - Jun 20, 2017
• Statistical Analysis Plan - Sep 28, 2018

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03073213
• Other Study ID Numbers: 15371; I1F-MC-RHBN
• First Posted: Mar 8, 2017
• Last Update Posted: Jul 22, 2020
• Last Verified: Jun 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Psoriasis; Ixekizumab

Study Results

Participant Flow

Recruitment Details	All the re-enrolled participants from single dose period (SDP) to multiple dose period (MDP) have been washed out and screened for eligibility to MDP.

Arm/Group Title	Ixekizumab Single Dose	Ixekizumab 80mg Q2W Multiple Dose	Ixekizumab 80mg Q4W Multiple Dose
Arm/Group Description	Participants received single dose of 80mg Ixekizumab by subcutaneous injection.	Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.	Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
Period Title: Single Dose Period
STARTED	12	0	0
COMPLETED	12	0	0
NOT COMPLETED	0	0	0
Period Title: Single Dose Period
STARTED	0	14	15
Participants Enrolled From Single Dose	0	7	2
COMPLETED	0	14	14
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	Ixekizumab Single Dose	Ixekizumab 80mg Q2W Multiple Dose	Ixekizumab 80mg Q4W Multiple Dose	Total
Arm/Group Description	Participants received single dose of 80mg Ixekizumab by subcutaneous injection.	Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.	Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.	Total of all reporting groups
Overall Participants	12	14	15	41
Age (years) [Mean (Standard Deviation) ]
Single Dose	49.0 (12.1)	49.0 (12.1)
Multiple Dose	45.6 (12.5)	45.5 (16.1)	45.6 (14.2)
Sex: Female, Male (Count of Participants)
Female	2 16.7%	0 0%	0 0%	2 4.9%
Male	10 83.3%	0 0%	0 0%	10 24.4%
Female	0 0%	3 21.4%	5 33.3%	8 19.5%
Male	0 0%	11 78.6%	10 66.7%	21 51.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	12 100%	0 0%	0 0%	12 29.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	14 100%	15 100%	29 70.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	12 100%	0 0%	0 0%	12 29.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	14 100%	15 100%	29 70.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Single Dose	12 100%	0 0%	0 0%	12 29.3%
Multiple Dose	0 0%	14 100%	15 100%	29 70.7%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)
Description	Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.
Time Frame	Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of Ixekizumab in single dose group and had evaluable PK data.

Arm/Group Title	Ixekizumab Single Dose
Arm/Group Description	Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
Measure Participants	12
Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter (ug/mL)]	6.90 (43)

2. Primary Outcome

Title	Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)
Description	Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.
Time Frame	Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of Ixekizumab in single dose group and had evaluable PK data.

Arm/Group Title	Ixekizumab Single Dose
Arm/Group Description	Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
Measure Participants	12
Geometric Mean (Geometric Coefficient of Variation) [Microgram*day per milliliter (ug*day/mL)]	147 (48)

3. Primary Outcome

Title	Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)
Description	Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.
Time Frame	day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of Ixekizumab in multiple dose group and had evaluable PK data.

Arm/Group Title	Ixekizumab 80mg Q2W Multiple Dose	Ixekizumab 80mg Q4W Multiple Dose
Arm/Group Description	Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.	Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
Measure Participants	14	14
Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter (ug/mL)]	19.9 (27)	13.4 (32)

4. Primary Outcome

Title	Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)
Description	Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose).
Time Frame	day 57 (Pre-dose), 59, 61, 64, 67, 71

Outcome Measure Data

Analysis Population Description

All randomized participants multiple dose period who received at least one dose of Ixekizumab and had evaluable PK data.

Arm/Group Title	Ixekizumab 80mg Q2W Multiple Dose	Ixekizumab 80mg Q4W Multiple Dose
Arm/Group Description	Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.	Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
Measure Participants	14	14
Geometric Mean (Geometric Coefficient of Variation) [Microgram*day per milliliter (ug*day/mL)]	224 (25)	136 (31)

5. Primary Outcome

Title	Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose)
Description	Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).
Time Frame	day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85

Outcome Measure Data

Analysis Population Description

All randomized participants in Ixekizumab Q4W arm who received at least one dose of Ixekizumab and had evaluable PK data.

Arm/Group Title	Ixekizumab 80mg Q4W Multiple Dose
Arm/Group Description	Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
Measure Participants	14
Geometric Mean (Geometric Coefficient of Variation) [Microgram*day per milliliter (ug*day/mL)]	213 (29)

Adverse Events

Time Frame	Baseline to end of the study (up to 20 weeks)
Adverse Event Reporting Description	All Randomized participants.
Arm/Group Title	Ixekizumab Single Dose		Ixekizumab 80mg Q2W Multiple Dose		Ixekizumab 80mg Q4W Multiple Dose
Arm/Group Description	Participants received single dose of 80mg Ixekizumab by subcutaneous injection.		Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.		Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
All Cause Mortality
	Ixekizumab Single Dose		Ixekizumab 80mg Q2W Multiple Dose		Ixekizumab 80mg Q4W Multiple Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/14 (0%)		0/15 (0%)
Serious Adverse Events
	Ixekizumab Single Dose		Ixekizumab 80mg Q2W Multiple Dose		Ixekizumab 80mg Q4W Multiple Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		1/14 (7.1%)		0/15 (0%)
Hepatobiliary disorders
Bile duct stone	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Cholecystitis	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Cholelithiasis	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Other (Not Including Serious) Adverse Events
	Ixekizumab Single Dose		Ixekizumab 80mg Q2W Multiple Dose		Ixekizumab 80mg Q4W Multiple Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/12 (91.7%)		11/14 (78.6%)		12/15 (80%)
Blood and lymphatic system disorders
Anaemia	1/12 (8.3%)	1	2/14 (14.3%)	2	0/15 (0%)	0
Thrombocytopenia	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Cardiac disorders
Cardiomegaly	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Sinus bradycardia	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Ventricular extrasystoles	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Eye disorders
Conjunctival hyperaemia	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Gastrointestinal disorders
Dental discomfort	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Diarrhoea	0/12 (0%)	0	3/14 (21.4%)	3	2/15 (13.3%)	2
Flatulence	3/12 (25%)	3	0/14 (0%)	0	0/15 (0%)	0
Frequent bowel movements	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Haematochezia	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Toothache	0/12 (0%)	0	2/14 (14.3%)	3	0/15 (0%)	0
General disorders
Asthenia	0/12 (0%)	0	2/14 (14.3%)	2	0/15 (0%)	0
Chest pain	0/12 (0%)	0	2/14 (14.3%)	5	0/15 (0%)	0
Injection site erythema	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Injection site pain	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Injection site pruritus	0/12 (0%)	0	1/14 (7.1%)	2	1/15 (6.7%)	1
Injection site reaction	0/12 (0%)	0	1/14 (7.1%)	2	1/15 (6.7%)	1
Injection site swelling	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Malaise	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Nodule	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Hepatobiliary disorders
Hepatic steatosis	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Infections and infestations
Bronchitis	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Fungal skin infection	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Gastroenteritis	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Gingivitis	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Nasopharyngitis	2/12 (16.7%)	2	1/14 (7.1%)	1	1/15 (6.7%)	1
Periodontitis	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Pharyngitis	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Pulpitis dental	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Tinea manuum	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Upper respiratory tract infection	2/12 (16.7%)	2	5/14 (35.7%)	5	3/15 (20%)	4
Urinary tract infection	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Investigations
Alanine aminotransferase increased	0/12 (0%)	0	2/14 (14.3%)	3	0/15 (0%)	0
Aspartate aminotransferase increased	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Blood alkaline phosphatase increased	1/12 (8.3%)	2	0/14 (0%)	0	0/15 (0%)	0
Blood cholesterol increased	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Blood glucose increased	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Blood potassium decreased	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Blood triglycerides increased	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Echocardiogram abnormal	0/12 (0%)	0	1/14 (7.1%)	1	1/15 (6.7%)	1
Electrocardiogram abnormal	1/12 (8.3%)	1	3/14 (21.4%)	4	2/15 (13.3%)	2
Glucose urine present	0/12 (0%)	0	1/14 (7.1%)	3	0/15 (0%)	0
Low density lipoprotein increased	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Neutrophil count decreased	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	2
Protein urine present	4/12 (33.3%)	4	2/14 (14.3%)	4	0/15 (0%)	0
Urine leukocyte esterase positive	1/12 (8.3%)	1	1/14 (7.1%)	2	0/15 (0%)	0
White blood cell count decreased	0/12 (0%)	0	0/14 (0%)	0	2/15 (13.3%)	4
White blood cells urine positive	0/12 (0%)	0	1/14 (7.1%)	2	0/15 (0%)	0
Metabolism and nutrition disorders
Diabetes mellitus	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Hypokalaemia	1/12 (8.3%)	1	0/14 (0%)	0	1/15 (6.7%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	0/12 (0%)	0	0/14 (0%)	0	2/15 (13.3%)	2
Back pain	1/12 (8.3%)	1	1/14 (7.1%)	1	0/15 (0%)	0
Musculoskeletal chest pain	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Musculoskeletal discomfort	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Pain in extremity	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Nervous system disorders
Dizziness	2/12 (16.7%)	2	1/14 (7.1%)	4	0/15 (0%)	0
Headache	1/12 (8.3%)	1	1/14 (7.1%)	5	0/15 (0%)	0
Hypoaesthesia	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Paraesthesia	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Renal and urinary disorders
Nocturia	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0
Breast pain	0/12 (0%)	0	1/14 (7.1%)	1	1/15 (6.7%)	1
Menstruation delayed	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Respiratory, thoracic and mediastinal disorders
Bronchial disorder	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Cough	1/12 (8.3%)	2	0/14 (0%)	0	1/15 (6.7%)	1
Nasal obstruction	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Oropharyngeal discomfort	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Oropharyngeal pain	2/12 (16.7%)	2	0/14 (0%)	0	2/15 (13.3%)	2
Productive cough	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Dermatitis allergic	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	2
Dry skin	1/12 (8.3%)	1	0/14 (0%)	0	2/15 (13.3%)	2
Eczema	0/12 (0%)	0	0/14 (0%)	0	1/15 (6.7%)	1
Erythema	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Nail psoriasis	0/12 (0%)	0	0/14 (0%)	0	2/15 (13.3%)	2
Papule	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Pruritus	5/12 (41.7%)	5	6/14 (42.9%)	10	2/15 (13.3%)	3
Seborrhoeic dermatitis	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Skin exfoliation	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Urticaria	2/12 (16.7%)	2	1/14 (7.1%)	1	1/15 (6.7%)	1
Vascular disorders
Hot flush	0/12 (0%)	0	1/14 (7.1%)	1	0/15 (0%)	0
Hypertension	1/12 (8.3%)	1	0/14 (0%)	0	0/15 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.