Trial Outcomes & Findings for Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis (NCT NCT02489227)
NCT ID: NCT02489227
Last Updated: 2020-04-08
Results Overview
The efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
545 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-04-08
Participant Flow
Participant milestones
| Measure |
CHS-1420
CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.
CHS-1420
|
Humira (Adalimumab) Reassigned to CHS-1420
Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to CHS-1420 40mg dose every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end.open label until study end.
Adalimumab
CHS-1420
|
Humira (Adalimumab)
Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to continue adalimumab treatment, 1 dose 40mg every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end..
Adalimumab
CHS-1420
|
|---|---|---|---|
|
Overall Study
STARTED
|
274
|
135
|
136
|
|
Overall Study
COMPLETED
|
220
|
101
|
117
|
|
Overall Study
NOT COMPLETED
|
54
|
34
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
CHS-1420
n=274 Participants
CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.
CHS-1420
|
Humira (Adalimumab) Reassigned to CHS-1420
n=135 Participants
Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to CHS-1420 40mg dose every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end.
Adalimumab
CHS-1420
|
Humira (Adalimumab)
n=136 Participants
Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to continue adalimumab treatment, 1 dose 40mg every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end.
Adalimumab
CHS-1420
|
Total
n=545 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
256 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
507 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
192 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
394 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established.
Outcome measures
| Measure |
Humira (Adalimumab)
n=271 Participants
Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to CHS-1420 or continue adalimumab treatment, 1 dose every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420 open label until study end.
CHS-1420
Adalimumab
|
CHS-1420
n=274 Participants
CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.
CHS-1420
|
|---|---|---|
|
Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12
|
203 Participants
|
211 Participants
|
Adverse Events
Treatment Period 1: CHS-1420
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
Treatment Period 1: Humira (Adalimumab)
Serious events: 6 serious events
Other events: 38 other events
Deaths: 0 deaths
Treatment Period 2: CHS-1420/CHS-1420
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Period 2: Humira/CHS-1420
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Teatment Period 2: Humira/Humira
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Period 3: Open Label CHS-1420 Extension
Serious events: 4 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment Period 1: CHS-1420
n=274 participants at risk
CHS-1420 40mg, 2 doses at Week 0/Day 0 then 40 mg, 1 dose every 2 weeks starting at Week 1 until Week 15
|
Treatment Period 1: Humira (Adalimumab)
n=271 participants at risk
Adalimumab (Humira) 40mg, 2 doses at Week 0/Day 0 then 40 mg, 1 dose every 2 weeks starting at Week 1 until Week 15.
|
Treatment Period 2: CHS-1420/CHS-1420
n=255 participants at risk
At week 16 subjects initially randomized to CHS-1420 will continue CHS-1420 treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24
|
Treatment Period 2: Humira/CHS-1420
n=126 participants at risk
At Week 16 subjects initially randomized to Humira (adalimumab) will be reassigned to CHS-1420 treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24
|
Teatment Period 2: Humira/Humira
n=130 participants at risk
At Week 16 subjects initially randomized to Humira (adalimumab) will continue adalimumab treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24
|
Treatment Period 3: Open Label CHS-1420 Extension
n=474 participants at risk
At week 24 all subjects will switch to CHS-1420 treatment 40 mg, 1 dose every 2 weeks, open label, starting at week 24 until study end
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.36%
1/274 • Number of events 1
|
0.00%
0/271
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/274
|
0.37%
1/271 • Number of events 1
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/274
|
0.37%
1/271 • Number of events 1
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Infections and infestations
Pneumonia
|
0.00%
0/274
|
0.37%
1/271 • Number of events 1
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.21%
1/474 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/274
|
0.37%
1/271 • Number of events 1
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/274
|
0.00%
0/271
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/274
|
0.37%
1/271 • Number of events 1
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/274
|
0.37%
1/271 • Number of events 1
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.36%
1/274 • Number of events 1
|
0.00%
0/271
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.36%
1/274 • Number of events 1
|
0.00%
0/271
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Respiratory, thoracic and mediastinal disorders
Chronic and obstructive pulmonary disease
|
0.00%
0/274
|
0.37%
1/271 • Number of events 1
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.36%
1/274 • Number of events 1
|
0.00%
0/271
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/274
|
0.00%
0/271
|
0.00%
0/255
|
0.79%
1/126 • Number of events 1
|
0.00%
0/130
|
0.00%
0/474
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/274
|
0.00%
0/271
|
0.39%
1/255 • Number of events 1
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/274
|
0.00%
0/271
|
0.39%
1/255 • Number of events 1
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Infections and infestations
Bronchitis
|
0.00%
0/274
|
0.00%
0/271
|
0.00%
0/255
|
0.79%
1/126 • Number of events 1
|
0.00%
0/130
|
0.00%
0/474
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/274
|
0.00%
0/271
|
0.00%
0/255
|
0.79%
1/126 • Number of events 1
|
0.00%
0/130
|
0.00%
0/474
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/274
|
0.00%
0/271
|
0.00%
0/255
|
0.00%
0/126
|
0.77%
1/130 • Number of events 1
|
0.00%
0/474
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/274
|
0.00%
0/271
|
0.39%
1/255 • Number of events 1
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/274
|
0.00%
0/271
|
0.39%
1/255 • Number of events 1
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Congenital, familial and genetic disorders
Congenital Cystic kidney disease
|
0.00%
0/274
|
0.00%
0/271
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.21%
1/474 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/274
|
0.00%
0/271
|
0.00%
0/255
|
0.79%
1/126 • Number of events 1
|
0.00%
0/130
|
0.00%
0/474
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/274
|
0.00%
0/271
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.21%
1/474 • Number of events 1
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/274
|
0.00%
0/271
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.21%
1/474 • Number of events 1
|
|
Vascular disorders
shock
|
0.00%
0/274
|
0.00%
0/271
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.21%
1/474 • Number of events 1
|
Other adverse events
| Measure |
Treatment Period 1: CHS-1420
n=274 participants at risk
CHS-1420 40mg, 2 doses at Week 0/Day 0 then 40 mg, 1 dose every 2 weeks starting at Week 1 until Week 15
|
Treatment Period 1: Humira (Adalimumab)
n=271 participants at risk
Adalimumab (Humira) 40mg, 2 doses at Week 0/Day 0 then 40 mg, 1 dose every 2 weeks starting at Week 1 until Week 15.
|
Treatment Period 2: CHS-1420/CHS-1420
n=255 participants at risk
At week 16 subjects initially randomized to CHS-1420 will continue CHS-1420 treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24
|
Treatment Period 2: Humira/CHS-1420
n=126 participants at risk
At Week 16 subjects initially randomized to Humira (adalimumab) will be reassigned to CHS-1420 treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24
|
Teatment Period 2: Humira/Humira
n=130 participants at risk
At Week 16 subjects initially randomized to Humira (adalimumab) will continue adalimumab treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24
|
Treatment Period 3: Open Label CHS-1420 Extension
n=474 participants at risk
At week 24 all subjects will switch to CHS-1420 treatment 40 mg, 1 dose every 2 weeks, open label, starting at week 24 until study end
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.8%
24/274 • Number of events 24
|
8.9%
24/271 • Number of events 24
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
17/274 • Number of events 17
|
5.2%
14/271 • Number of events 14
|
0.00%
0/255
|
0.00%
0/126
|
0.00%
0/130
|
0.00%
0/474
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place