Trial Outcomes & Findings for Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa (NCT NCT02670330)
NCT ID: NCT02670330
Last Updated: 2019-09-27
Results Overview
TEAEs were defined as adverse events that started or worsened on or after baseline visit.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
152 participants
Primary outcome timeframe
From baseline to 30 days after last application of study drug (up to a maximum of 37 months)
Results posted on
2019-09-27
Participant Flow
152 participants with epidermolysis bullosa (EB) were enrolled between 9 June 2015 and 5 July 2017 in this open-label, multi-center extension study. All enrolled participants had previously completed Study SD-005 (NCT02384460).
Analysis groups were defined based on prior treatment in Study SD-005: 77 participants who received placebo were allocated to the 'Placebo to Zorblisa™ (SD-101-6.0)' group and 75 participants who received SD-101-6.0 were allocated to the 'SD-101-6.0 to SD-101-6.0' group. All participants received SD-101-6.0 upon enrolling in Study SD-006.
Participant milestones
| Measure |
SD-101-6.0 to SD-101-6.0
Participants who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
Placebo to SD-101-6.0
Participants who received placebo in Study SD-005 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
77
|
|
Overall Study
Received At Least 1 Dose Of Study Drug
|
75
|
77
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
75
|
77
|
Reasons for withdrawal
| Measure |
SD-101-6.0 to SD-101-6.0
Participants who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
Placebo to SD-101-6.0
Participants who received placebo in Study SD-005 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
|---|---|---|
|
Overall Study
Protocol Deviation
|
1
|
0
|
|
Overall Study
Study Terminated By Sponsor
|
36
|
43
|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
34
|
29
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa
Baseline characteristics by cohort
| Measure |
SD-101-6.0 to SD-101-6.0
n=75 Participants
Participants who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
Placebo to SD-101-6.0
n=77 Participants
Participants who received placebo in Study SD-005 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.18 years
STANDARD_DEVIATION 13.381 • n=5 Participants
|
14.36 years
STANDARD_DEVIATION 13.599 • n=7 Participants
|
14.27 years
STANDARD_DEVIATION 13.447 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
65 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
EB Type
Simplex
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
EB Type
Recessive Dystrophic
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
EB Type
Junctional Non-Herlitz
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to 30 days after last application of study drug (up to a maximum of 37 months)Population: Safety Population: all participants who applied/were administered the study drug at least once.
TEAEs were defined as adverse events that started or worsened on or after baseline visit.
Outcome measures
| Measure |
SD-101-6.0 to SD-101-6.0
n=75 Participants
Participants who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
Placebo to SD-101-6.0
n=77 Participants
Participants who received placebo in Study SD-005 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
|---|---|---|
|
Number Of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE
|
51 Participants
|
58 Participants
|
|
Number Of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE Related To Study Drug
|
8 Participants
|
17 Participants
|
|
Number Of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Fatal TEAE
|
0 Participants
|
0 Participants
|
|
Number Of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Serious TEAE
|
11 Participants
|
14 Participants
|
|
Number Of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE Leading To Discontinuation
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, up to Month 30Population: Intent-to-treat (ITT) population: all participants who rolled over from Study SD-005 and had data available for analysis at each specified time point.
Lesional skin was defined as areas that contained any of the following: blisters, erosions, ulcerations, scabbing, bullae, or eschars, as well as areas that were weeping, sloughing, oozing, crusted, or denuded. The percentage, ranging from 0% to 100%, of affected body surface area (BSA) was recorded for each defined body region (that is, head/neck, upper limbs, trunk \[includes groin\], and lower limbs), multiplied by the weighting factor, then summed for all body regions to calculate the BSAI that would range from 0% to 100%. The BSA for lesional skin was to be assessed by the same study physician on each visit for a particular participant. The mean change from baseline in BSAI was assessed every 3 months. Only participants with data available for analysis at each time point are presented.
Outcome measures
| Measure |
SD-101-6.0 to SD-101-6.0
n=75 Participants
Participants who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
Placebo to SD-101-6.0
n=77 Participants
Participants who received placebo in Study SD-005 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
|---|---|---|
|
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30
Month 1
|
-0.76 Percentage of BSAI
Standard Deviation 4.185
|
-0.54 Percentage of BSAI
Standard Deviation 5.398
|
|
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30
Month 3
|
-1.87 Percentage of BSAI
Standard Deviation 5.999
|
-1.21 Percentage of BSAI
Standard Deviation 6.457
|
|
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30
Month 6
|
-1.77 Percentage of BSAI
Standard Deviation 6.015
|
-1.35 Percentage of BSAI
Standard Deviation 6.813
|
|
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30
Month 9
|
-2.48 Percentage of BSAI
Standard Deviation 9.436
|
0.31 Percentage of BSAI
Standard Deviation 10.117
|
|
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30
Month 12
|
-3.35 Percentage of BSAI
Standard Deviation 9.566
|
0.44 Percentage of BSAI
Standard Deviation 10.327
|
|
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30
Month 15
|
-1.90 Percentage of BSAI
Standard Deviation 7.337
|
2.15 Percentage of BSAI
Standard Deviation 12.546
|
|
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30
Month 18
|
-2.46 Percentage of BSAI
Standard Deviation 5.275
|
-4.24 Percentage of BSAI
Standard Deviation 8.207
|
|
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30
Month 21
|
-3.06 Percentage of BSAI
Standard Deviation 5.869
|
-1.58 Percentage of BSAI
Standard Deviation 10.442
|
|
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30
Month 24
|
-1.63 Percentage of BSAI
Standard Deviation 5.647
|
-0.64 Percentage of BSAI
Standard Deviation 5.981
|
|
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30
Month 27
|
-1.87 Percentage of BSAI
Standard Deviation 4.405
|
-0.16 Percentage of BSAI
Standard Deviation 6.514
|
|
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30
Month 30
|
-2.77 Percentage of BSAI
Standard Deviation 5.465
|
3.37 Percentage of BSAI
Standard Deviation 10.706
|
SECONDARY outcome
Timeframe: Baseline, up to Month 30Population: Intent-to-treat (ITT) population: all participants who rolled over from Study SD-005 and had data available for analysis at each specified time point.
A wound was defined as an open area on the skin (that is, epidermal covering disrupted). Total body wound burden was calculated using BSAI; the percentage, ranging from 0% to 100%, of affected BSA was recorded for each defined body region (that is, head/neck, upper limbs, trunk \[includes groin\], and lower limbs), multiplied by the weighting factor, then summed for all body regions to calculate the BSAI that would range from 0% to 100%. The BSAI for total body wound burden was to be assessed by the same study physician at each visit for a particular participant. The mean change from baseline in total body wound burden was assessed every 3 months. Only participants with data available for analysis at each time point are presented.
Outcome measures
| Measure |
SD-101-6.0 to SD-101-6.0
n=75 Participants
Participants who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
Placebo to SD-101-6.0
n=77 Participants
Participants who received placebo in Study SD-005 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
|---|---|---|
|
Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30
Month 1
|
-1.75 Percentage of BSAI
Standard Deviation 4.891
|
0.07 Percentage of BSAI
Standard Deviation 4.044
|
|
Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30
Month 3
|
-1.52 Percentage of BSAI
Standard Deviation 5.343
|
-0.80 Percentage of BSAI
Standard Deviation 3.001
|
|
Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30
Month 6
|
-1.54 Percentage of BSAI
Standard Deviation 4.322
|
-0.48 Percentage of BSAI
Standard Deviation 3.595
|
|
Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30
Month 9
|
-1.82 Percentage of BSAI
Standard Deviation 6.083
|
-0.42 Percentage of BSAI
Standard Deviation 3.586
|
|
Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30
Month 12
|
-1.38 Percentage of BSAI
Standard Deviation 5.497
|
-0.13 Percentage of BSAI
Standard Deviation 3.211
|
|
Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30
Month 15
|
-0.15 Percentage of BSAI
Standard Deviation 4.511
|
0.26 Percentage of BSAI
Standard Deviation 3.030
|
|
Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30
Month 18
|
-1.12 Percentage of BSAI
Standard Deviation 3.053
|
-1.31 Percentage of BSAI
Standard Deviation 4.665
|
|
Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30
Month 21
|
-1.44 Percentage of BSAI
Standard Deviation 3.150
|
-0.28 Percentage of BSAI
Standard Deviation 5.507
|
|
Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30
Month 24
|
-0.68 Percentage of BSAI
Standard Deviation 3.890
|
-0.01 Percentage of BSAI
Standard Deviation 2.898
|
|
Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30
Month 27
|
-0.43 Percentage of BSAI
Standard Deviation 2.924
|
0.31 Percentage of BSAI
Standard Deviation 3.615
|
|
Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30
Month 30
|
-1.55 Percentage of BSAI
Standard Deviation 2.883
|
1.69 Percentage of BSAI
Standard Deviation 5.933
|
Adverse Events
SD-101-6.0 to SD-101-6.0
Serious events: 11 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo to SD-101-6.0
Serious events: 14 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SD-101-6.0 to SD-101-6.0
n=75 participants at risk
Participants who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
Placebo to SD-101-6.0
n=77 participants at risk
Participants who received placebo in Study SD-005 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Cardiac disorders
Pericarditis
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Congenital, familial and genetic disorders
Congenital megaureter
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Eye disorders
Keratitis
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Faecaloma
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Implant site infection
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Infection
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Otitis media
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Skin infection
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Wound infection
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Wound infection bacterial
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Injury, poisoning and procedural complications
Stoma site extravasation
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Injury, poisoning and procedural complications
Stoma site inflammation
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Investigations
Body temperature increased
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary-mucinous carcinoma of pancreas
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Psychiatric disorders
Intermittent explosive disorder
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
Other adverse events
| Measure |
SD-101-6.0 to SD-101-6.0
n=75 participants at risk
Participants who received SD-101-6.0 in Study SD-005 continued to receive SD-101-6.0 in this open label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
Placebo to SD-101-6.0
n=77 participants at risk
Participants who received placebo in Study SD-005 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically once a day to the entire body.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
5/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
6.5%
5/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Congenital, familial and genetic disorders
Epidermolysis bullosa
|
4.0%
3/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
3.9%
3/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Constipation
|
6.7%
5/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
3.9%
3/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
3.9%
3/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.0%
3/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Oesophageal dilatation
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
4.0%
3/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
5.2%
4/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Toothache
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
3.9%
3/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
General disorders
Pain
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
General disorders
Pyrexia
|
6.7%
5/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
13.0%
10/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Bronchitis
|
6.7%
5/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Cellulitis
|
4.0%
3/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Cystitis
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Eye infection
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
3.9%
3/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Influenza
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
3.9%
3/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
10/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
7.8%
6/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Otitis media
|
4.0%
3/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Pharyngitis streptococcal
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
5.2%
4/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Pyoderma
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Rhinitis
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Sinusitis
|
5.3%
4/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Skin bacterial infection
|
5.3%
4/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
5.2%
4/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Skin infection
|
8.0%
6/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
15.6%
12/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Staphylococcal skin infection
|
5.3%
4/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
5.2%
4/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
4/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
6.5%
5/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Urinary tract infection
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Viral rash
|
0.00%
0/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Wound infection
|
4.0%
3/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
7.8%
6/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Wound infection bacterial
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
6.5%
5/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Wound infection pseudomonas
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Infections and infestations
Wound infection staphylococcal
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
3.9%
3/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.0%
3/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Injury, poisoning and procedural complications
Wound
|
4.0%
3/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
0.00%
0/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Psychiatric disorders
Anxiety
|
1.3%
1/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
3.9%
3/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
4/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
3.9%
3/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
1.3%
1/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
3/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
7.8%
6/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.7%
2/75 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
2.6%
2/77 • From baseline to 30 days after last application of study drug (up to a maximum of 37 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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 from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER