Safety and Efficacy of Secukinumab in Mild Psoriasis

• Sponsor: James G. Krueger, MD, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT03131570
• Collaborator: Novartis (Industry)
• Enrollment: 23
• Location: 1
• Arms: 2
• Actual Duration (Months): 49
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Mild psoriasis not only progresses to moderate-to-severe psoriasis but also precedes systemic inflammation that leads to psoriatic arthritis and cardiovascular comorbidities. By curing mild psoriasis with a short-term anti- interleukin (IL)-17A treatment, investigators may reduce the costs of treating psoriasis and associated medical conditions, including psoriatic arthritis, cardiovascular disease, and diabetes.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: Secukinumab; Drug: Placebo followed by Secukinumab	Phase 2

Detailed Description

Psoriasis is an immune-mediated disease of the skin that, even in mild disease, increases the risk of comorbidities such as cardiovascular disease and metabolic derangements. Mild psoriasis tends to be treated with topical drugs, while moderate-to-severe disease is optimally treated with systemic immune modulators. However, the treatment of "mild" psoriasis needs to be re-thought because recent studies have revealed that mild psoriasis is characterized by stronger expression of pathogenic molecules, such as interleukin (IL)-17A, and higher numbers of T cells in the skin, compared to severe psoriasis. A key distinction between mild and severe psoriasis is now discovered to be the higher expression of negative immune regulatory genes in mild lesions. Therefore, targeted immune therapy with anti-IL-17A, which is highly effective in severe psoriasis, might be equally (or even more) effective in mild disease. Also, restoration of immune tolerance might be more easily achieved in mild disease. Thus, short-term anti-IL-17A treatment of mild psoriasis might prevent the recurrence and eventually cure the disease. The aim of study is to test this hypothesis by exploring whether 3 months or 6 months of anti-IL17A treatment will prevent relapses after medication has been discontinued in mild psoriasis patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: To compare the secukinumab-receiving mild psoriasis subjects (Group 1) and the placebo-receiving mild psoriasis subjects (Group 2).To compare the secukinumab-receiving mild psoriasis subjects (Group 1) and the placebo-receiving mild psoriasis subjects (Group 2).
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Secukinumab in Adults With Chronic Plaque Type Psoriasis With a PASI Score of 6 to 12
• Actual Study Start Date: May 23, 2017
• Actual Primary Completion Date: Jan 8, 2020
• Actual Study Completion Date: Jun 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 6 months of Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period.	Drug: Secukinumab; Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).; Other Names: COSENTYX
Placebo Comparator: Group 2 Placebo followed by Secukinumab. 3 months of placebo followed by 3 months of Secukinumab at a dose of 300 mg with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period.	Drug: Placebo followed by Secukinumab; Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).; Other Names: Placebo followed by COSENTYX

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects Who Have 75% or More Reduction in [Psoriasis Area-and-severity Index Score (PASI)] (PASI75) [week 12]

   The percentage of subjects who have a reduction of 75% or more from baseline in the Psoriasis Area and Severity Index (PASI) at week 12 (PASI 75). Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)

Secondary Outcome Measures

1. Percentage of Subjects Who Have 90% or More Reduction in [Psoriasis Area-and-severity Index Score (PASI)] (PASI90) [week 12]

   The percentage of subjects who have a reduction of 90% or more from baseline in the Psoriasis Area and Severity Index (PASI) at week 12 (PASI 90). Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)

2. Percentage of Subjects Who Achieve a Score of 0 on a 5-point Modified Investigator's Global Assessment (IGA0) [week 12]

   The percentage of subjects who achieve a score of 0 (clear) on a 5-point modified investigator's global assessment (IGA) at week 12.

3. Percentage of Subjects Who Experience Psoriasis Relapse [week 24 through week 72]

   The percentage of subjects who experience a psoriasis relapse at any time between week 24 and week 72. Psoriasis relapse is defined as loss of > 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at week 24. Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)

4. Severity of Relapses [Observation Period: week 24 through week 72.]

   Severity of the relapses over the observation period.

5. Extent of Relapses Measured by the Percentage of Relapse Frequencies Between Subjects Who Achieve Clearance of Psoriasis and Subjects Who do Not Achieve Clearance of Psoriasis. [Observation Period: week 24 through week 72]

   Extent of relapses measured by the percentage of relapse frequencies between subjects who achieve a score of 0 (clear) on IGA (Investigator's Global Assessment) and subjects who do not achieve a score of 0 (clear) on IGA over the observation period.

6. Elapsed Time Until Relapse [week 24 until week 72]

   Elapsed time from week 24 until relapse occurs before week 72, measured in weeks.

7. Percentage of Subjects Who Have 90% or 100% Reduction in [Psoriasis Area-and-severity Index Score (PASI)] (PASI90 or PASI100) [week 12]

   The percentage of subjects who have a reduction of 90% or 100% from baseline in the Psoriasis Area and Severity Index (PASI) score (PASI90 or PASI100) at week 12. Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)

8. Frequency of Adverse Events and Serious Adverse Events [week 0 through week 72]

   Frequency of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).

9. Severity of Adverse Events and Serious Adverse Events [week 0 through week 72]

   Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed

2. 18 years of age or older

3. Chronic plaque-type psoriasis for at least 6 months

4. Negative PPD (negative chest w-ray if positive) or negative QuantiFERON-TB Gold

5. Have a PASI between 6 and 12 and Body Surface Area (BSA) affected by plaque-type psoriasis less than 10% at screening and baseline

6. Willing to wash off steroid creams and ultraviolet B light (UVB) therapy for 2 weeks prior to the baseline visit

Exclusion Criteria:

1. Has a nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular)

2. Has previously received Secukinumab or other biologics

3. History of Inflammatory Bowel Disease (IBD)

4. History of Rheumatoid Arthritis

5. Use of topical treatments for psoriasis, including steroids, vitamin D derivatives, vitamin A derivatives, salicylic acid, tar (except moisturizers) and/or ultraviolet A light (UVA)/UVB phototherapy within the last 2 weeks (if these have used them, the participant needs to wash off of them for at least 2 weeks after signing consent prior to baseline)

6. Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug

7. Has recently received or is planning to receive a vaccination while on the study

8. HIV positive

9. Chronic untreated hepatitis C, positive hepatitis B surface antigen and acute hepatitis A infection

10. Known tuberculosis (TB) or evidence of TB infection. Subjects with a positive QuantiFERON; TB test or a positive purified protein derivate (PPD) skin test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active TB.

11. Any severe, progressive or uncontrolled medical condition at screening that in the judgment of the investigator prevents the subject from participating in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Rockefeller Univesity	New York	New York	United States	10065

Sponsors and Collaborators

• James G. Krueger, MD, PhD
• Novartis

Investigators

• Principal Investigator: James G Krueger, MD, PhD, Rockefeller University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 19, 2021

More Information

Publications

• Kim J, Bissonnette R, Lee J, Correa da Rosa J, Suárez-Fariñas M, Lowes MA, Krueger JG. The Spectrum of Mild to Severe Psoriasis Vulgaris Is Defined by a Common Activation of IL-17 Pathway Genes, but with Key Differences in Immune Regulatory Genes. J Invest Dermatol. 2016 Nov;136(11):2173-2182. doi: 10.1016/j.jid.2016.04.032. Epub 2016 May 13.
• Kim J, Krueger JG. The immunopathogenesis of psoriasis. Dermatol Clin. 2015 Jan;33(1):13-23. doi: 10.1016/j.det.2014.09.002. Review.
• Kim J, Nadella P, Kim DJ, Brodmerkel C, Correa da Rosa J, Krueger JG, Suárez-Fariñas M. Histological Stratification of Thick and Thin Plaque Psoriasis Explores Molecular Phenotypes with Clinical Implications. PLoS One. 2015 Jul 15;10(7):e0132454. doi: 10.1371/journal.pone.0132454. eCollection 2015.
• Kim J, Oh CH, Jeon J, Baek Y, Ahn J, Kim DJ, Lee HS, Correa da Rosa J, Suárez-Fariñas M, Lowes MA, Krueger JG. Molecular Phenotyping Small (Asian) versus Large (Western) Plaque Psoriasis Shows Common Activation of IL-17 Pathway Genes but Different Regulatory Gene Sets. J Invest Dermatol. 2016 Jan;136(1):161-172. doi: 10.1038/JID.2015.378.

• Responsible Party: James G. Krueger, MD, PhD, Head of the Laboratory for Investigative Dermatology, Rockefeller University
• ClinicalTrials.gov Identifier: NCT03131570
• Other Study ID Numbers: JKR-0937
• First Posted: Apr 27, 2017
• Last Update Posted: Nov 1, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by James G. Krueger, MD, PhD, Head of the Laboratory for Investigative Dermatology, Rockefeller University: Psoriasis; Chronic Plaque Psoriasis; Secukinumab
• Additional relevant MeSH terms: Psoriasis; Antibodies, Monoclonal

Study Results

Participant Flow

Arm/Group Title	Secukinumab Only	Placebo Then Secukinumab
Arm/Group Description	6 months of Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. Secukinumab: Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).	Placebo followed by Secukinumab. 3 months of placebo followed by 3 months of Secukinumab at a dose of 300 mg with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Placebo followed by Secukinumab: Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).
Period Title: Overall Study
STARTED	12	11
COMPLETED	11	11
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Group 1	Group 2	Total
Arm/Group Description	6 months of Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. Secukinumab: Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).	Placebo followed by Secukinumab. 3 months of placebo followed by 3 months of Secukinumab at a dose of 300 mg with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Placebo followed by Secukinumab: Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).	Total of all reporting groups
Overall Participants	12	11	23
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 83.3%	11 100%	21 91.3%
>=65 years	2 16.7%	0 0%	2 8.7%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	47	43	44.0
Sex: Female, Male (Count of Participants)
Female	5 41.7%	2 18.2%	7 30.4%
Male	7 58.3%	9 81.8%	16 69.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 16.7%	5 45.5%	7 30.4%
Not Hispanic or Latino	9 75%	6 54.5%	15 65.2%
Unknown or Not Reported	1 8.3%	0 0%	1 4.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 8.3%	0 0%	1 4.3%
Asian	2 16.7%	1 9.1%	3 13%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	7 58.3%	6 54.5%	13 56.5%
More than one race	0 0%	1 9.1%	1 4.3%
Unknown or Not Reported	2 16.7%	3 27.3%	5 21.7%
Region of Enrollment (participants) [Number]
United States	12 100%	11 100%	23 100%
Psoriasis Area-Severity Index (PASI) (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	7.100	8.900	8.200

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Who Have 75% or More Reduction in [Psoriasis Area-and-severity Index Score (PASI)] (PASI75)
Description	The percentage of subjects who have a reduction of 75% or more from baseline in the Psoriasis Area and Severity Index (PASI) at week 12 (PASI 75). Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

One participant in Group 1 was not included in the data analysis due to a serious adverse event before the primary endpoint, unrelated to study medication or study participation.

Arm/Group Title	Group 1	Group 2
Arm/Group Description	6 months of Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. Secukinumab: Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).	Placebo followed by Secukinumab. 3 months of placebo followed by 3 months of Secukinumab at a dose of 300 mg with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Placebo followed by Secukinumab: Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).
Measure Participants	11	11
Count of Participants [Participants]	8 66.7%	0 0%

2. Secondary Outcome

Title	Percentage of Subjects Who Have 90% or More Reduction in [Psoriasis Area-and-severity Index Score (PASI)] (PASI90)
Description	The percentage of subjects who have a reduction of 90% or more from baseline in the Psoriasis Area and Severity Index (PASI) at week 12 (PASI 90). Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Percentage of Subjects Who Achieve a Score of 0 on a 5-point Modified Investigator's Global Assessment (IGA0)
Description	The percentage of subjects who achieve a score of 0 (clear) on a 5-point modified investigator's global assessment (IGA) at week 12.
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Percentage of Subjects Who Experience Psoriasis Relapse
Description	The percentage of subjects who experience a psoriasis relapse at any time between week 24 and week 72. Psoriasis relapse is defined as loss of > 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at week 24. Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)
Time Frame	week 24 through week 72

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Severity of Relapses
Description	Severity of the relapses over the observation period.
Time Frame	Observation Period: week 24 through week 72.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Extent of Relapses Measured by the Percentage of Relapse Frequencies Between Subjects Who Achieve Clearance of Psoriasis and Subjects Who do Not Achieve Clearance of Psoriasis.
Description	Extent of relapses measured by the percentage of relapse frequencies between subjects who achieve a score of 0 (clear) on IGA (Investigator's Global Assessment) and subjects who do not achieve a score of 0 (clear) on IGA over the observation period.
Time Frame	Observation Period: week 24 through week 72

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Elapsed Time Until Relapse
Description	Elapsed time from week 24 until relapse occurs before week 72, measured in weeks.
Time Frame	week 24 until week 72

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Percentage of Subjects Who Have 90% or 100% Reduction in [Psoriasis Area-and-severity Index Score (PASI)] (PASI90 or PASI100)
Description	The percentage of subjects who have a reduction of 90% or 100% from baseline in the Psoriasis Area and Severity Index (PASI) score (PASI90 or PASI100) at week 12. Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Frequency of Adverse Events and Serious Adverse Events
Description	Frequency of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).
Time Frame	week 0 through week 72

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Severity of Adverse Events and Serious Adverse Events
Description	Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).
Time Frame	week 0 through week 72

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	3 years
Arm/Group Title	Group 1		Group 2
Arm/Group Description	6 months of Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. Secukinumab: Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).		Placebo followed by Secukinumab. 3 months of placebo followed by 3 months of Secukinumab at a dose of 300 mg with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Placebo followed by Secukinumab: Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).
All Cause Mortality
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)
Serious Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		0/11 (0%)
Cardiac disorders
Acute coronary syndrome	1/12 (8.3%)	1	0/11 (0%)	0
Other (Not Including Serious) Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/12 (83.3%)		9/11 (81.8%)
Eye disorders
eye disorders- blepheritis	1/12 (8.3%)	1	0/11 (0%)	0
Gastrointestinal disorders
Diarrhea	1/12 (8.3%)	1	1/11 (9.1%)	1
Gastroesophageal reflux disease	1/12 (8.3%)	1	0/11 (0%)	0
Gingival pain	1/12 (8.3%)	1	0/11 (0%)	0
General disorders
Flu like symptoms	0/12 (0%)	0	1/11 (9.1%)	1
Fatigue	0/12 (0%)	0	1/11 (9.1%)	1
Non-cardiac chest pain	1/12 (8.3%)	1	1/11 (9.1%)	1
Immune system disorders
allergic reaction	1/12 (8.3%)	1	1/11 (9.1%)	1
Infections and infestations
tooth infection	0/12 (0%)	0	1/11 (9.1%)	1
upper respiratory infection	5/12 (41.7%)	5	1/11 (9.1%)	1
Injury, poisoning and procedural complications
Fall	0/12 (0%)	0	1/11 (9.1%)	1
Fracture	1/12 (8.3%)	1	0/11 (0%)	0
Investigations
Blood bilirubin increased	1/12 (8.3%)	1	0/11 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	1/12 (8.3%)	1	1/11 (9.1%)	1
Myalgia	1/12 (8.3%)	1	1/11 (9.1%)	1
Pain in extremity	0/12 (0%)	0	2/11 (18.2%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benig, malignant and unspecified (incl cysts and polyps), other: breast cyst	1/12 (8.3%)	1	0/11 (0%)	0
Nervous system disorders
Headache	1/12 (8.3%)	1	0/11 (0%)	0
Respiratory, thoracic and mediastinal disorders
Sore throat	2/12 (16.7%)	2	0/11 (0%)	0
Skin and subcutaneous tissue disorders
Pruritis	1/12 (8.3%)	1	0/11 (0%)	0
Rash maculopapular	0/12 (0%)	0	1/11 (9.1%)	1
skin and subcutaneous tissue disorders, other: folliculitis	1/12 (8.3%)	2	0/11 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.