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  1. Development & Approval Process | Drugs

Drug Trials Snapshot: COSENTYX (secukinumab)

HOW TO USE THIS SNAPSHOT:
The information provided in Snapshots highlights who participated in the clinical trials that  supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the COSENTYX Package Insert for complete information.

COSENTYX (secukinumab)
Koe-SEN-tix
Novartis Pharmaceuticals Corporation
Approval date: January 21, 2015


DRUG TRIALS SUMMARY: 

What is the drug for?

COSENTYX is used to treat moderate to severe plaque psoriasis in adults who do not respond well to medication applied directly to the skin.

How do I use this drug?

COSENTYX is an injection given once a week for five consecutive weeks followed by an injection once every four weeks.

What are the benefits of this drug?

Clinical trials showed that COSENTYX was better than a placebo in improving symptoms of plaque psoriasis and sustaining the improvement through a year of treatment.

What are the benefits of this drug (results of trials used to assess efficacy)?

The co-primary endpoints of the pivotal trials were:

  • The proportion of patients achieving a minimum 75% reduction in the  Psoriasis Area and Severity Index (PASI) score
  • The proportion of patients scoring 0 or 1 at Week 12 on the Investigator’s Global Assessment (IGA)

The Table below summarizes clinical response rates in the two pivotal trials.
Table 5. Results of the Co-primary Efficacy Endpoints at Week 12

  Trial 1 Trial 2
COSENTYX
300 mg
(N=245)
COSENTYX
150 mg
(N=245)
Placebo
(N=248)
COSENTYX
300 mg
(N=327)
COSENTYX
150 mg
(N=327)
Placebo
(N=326)
Biologic Active Comparator
(N=326)
Co-primary endpoints
IGA of clear or almost clear 160 (65%) 125 (51%) 6 (2%) 202 (62%) 167 (51%) 9 (3%) 88 (27%)
PASI 75 Response 200 (82%) 174 (71%) 11 (4%) 249 (76%) 219 (67%) 16 (5%) 142 (44%)

Source: FDA Clinical Review, Table 6

Were there any differences in how well the drug worked in clinical trials among sex, race and age?
Subgroup analyses were conducted for sex, race, and age.

  • Sex:  COSENTYX was similarly effective in men and women.
  • Race:  The number of non-white patients was limited; therefore, differences in response between white and non-white patients could not be determined.
  • Age: The number of patients above 65 years of age was limited; therefore, differences in response between patients above and below 65 years of age could not be determined.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age?

Table 6. IGA Success by Gender, Age, Race, and Weight for the Pivotal Trials (Trial 1 and Trial 2)

  Trial 1 Trial 2
COSENTYX Placebo
N=248
COSENTYX Placebo
N=326
Biologic active comparator
N=326
300 mg
N=245
150 mg
N=245
300 mg
N=327
150 mg
N=327
Sex

Female

51/76
(67%)
43/77
(56%)
5/76
(7%)
60/103
(58%)
58/91
(64%)
2/89
(2%)
25/94
(26%)

Male

109/169
(65%)
82/168
(49%)
1/172
(0.6%)
142/224
(63%)
109/236
(46%)
7/237
(3%)
63/232
(27%)
Age

<>

149/228
(65%)
112/225
(59%)
6/229
(3%)
194/311
(62%)
161/310
(52%)
9/311
(3%)
85/313
(27%)

≥65

11/17
(65%)
13/20
(65%)
0/19
(0%)
8/16
(50%)
6/17
(35%)
0/15
(0%)
3/13
(23%)
Race

Asian

33/52
(63%)
31/54
(57%)
1/47
(2%)
33/73
(45%)
27/72
(38%)
2/72
(3%)
13/74
(17%)

Black

2/4 3/5 0/9 2/2 3/3 0/3 -

Caucasian

110/171
(64%)
82/171
(48%)
3/176
(2%)
143/224
(64%)
118/219
(54%)
5/217
(2%)
60/219
(27%)

Native
American

5/7 2/5 0/3 18/22
(81%)
18/28
(64%)
2/25
(8%)
12/27
(44%)

Pacific Islander

2/3 1/1 - 1/1 - 0/1 0/1

Other

6/6 6/9 2/13 5/5 1/5 0/5 3/4

Unknown

2/2 - - - - 0/2 0/1

Extracted from FDA Statistical Review, Table 39

What are the possible side effects?

The most common side effects were common cold, diarrhea, and upper respiratory tract infection.

COSENTYX is a medicine that affects the immune system; therefore, it can decrease a patient’s ability to fight infections and lead to an increased risk of infections.

Before a patient is started on COSENTYX, patients should first be evaluated for tuberculosis infection.

In patients with Crohn’s disease, “flare-ups” can happen with COSENTYX, and can sometimes be serious. There were cases of serious allergic reactions in some patients treated with COSENTYX in the clinical trials. Also, the cap of the COSENTYX pen which delivers the drug and the COSENTYX prefilled syringe both contain natural rubber latex which may cause an allergic reaction in latex-sensitive individuals.

What are the possible side effects (results of trials used to assess safety)?
The most common adverse events (AEs) in patients treated with any dose of COSENTYX were nasopharyngitis (12%), headache (6%), and diarrhea (3%). The table below summarizes the AEs that occurred at a rate of at least 1% and at a higher rate in the COSENTYX groups compared to the placebo group during the 12-week placebo-controlled period used for the safety analysis.

Table 7. Most frequent (≥2% in any group) AEs by preferred term up to 12 weeks

Adverse Reaction COSENTYX Placebo
N=694
n (%)
150 mg
N=692
n (%)
300 mg
N=690
n (%)
Nasopharyngitis 85 (12.3) 79 (11.4) 60 (8.6)
Headache 38 (5.5) 45 (6.5) 36 (5.2)
Diarrhea 18 (2.6) 28 (4.1) 10 (1.4)
Pruritus 21 (3.0) 23 (3.3) 18 (2.6)
Upper respiratory tract infection 22 (3.2) 17 (2.5) 5 (0.7)
Oropharyngeal pain 17 (2.5) 15 (2.2) 12 (1.7)
Arthralgia 20 (2.9) 9 (1.3) 17 (2.4)
Hypertension 22 (3.2) 7 (1.0) 12 (1.7)
Cough 9 (1.3) 19 (2.8) 9 (1.3)
Back pain 12 (1.7) 14 (2.0) 10 (1.4)
Nausea 12 (1.7) 14 (2.0) 14 (2.0)
Fatigue 14 (2.0) 10 (1.4) 7 (1.0)
Psoriasis 10 (1.4) 4 (0.6) 20 (2.9)
Pyrexia 4 (0.6) 10 (1.4) 6 (0.9)
Injection site erythema 0 (0.0) 1 (0.1) 0 (0.0)

Extracted from FDA Statistical Review, Table 39

Were there any differences in side effects among sex, race and age?

Subgroup analyses were conducted for sex, race, and age subgroups.

  • Sex:  The risk of side effects was similar in men and women.
  • Race:  The number of patients in the non-white subgroup was limited. Therefore, differences among races could not be detected.
  • Age: The risk of side effects was similar in patients below and above age 65 years.

Were there any differences in side effects of the clinical trials among sex, race, and age?

The tables below summarize the incidence of adverse events by demographic subgroup for the entire 52-week treatment period. The results for the 12-week placebo-controlled period were consistent with these analyses.

Table 9. Exposure-adjusted incidence of adverse events by gender (52-week treatment period) most frequent SOCs

Gender subgroup COSENTYX 150 mg
n (IR)
COSENTYX 300 mg
n (IR)
COSENTYX dose
n (IR)
Placebo
n (IR)
Biologic Active Comparator
n (IR)
Primary system organ class
Male – N 958 974 2406 552 229

Any AE

702 (214.8) 750 (226.1) 1809 (236.6) 279 (338.7) 171 (209.9)

Infections and infestations

413 (75.5) 469 (84.3) 1084 (83.3) 112 (95.1) 116 (85.1)

Skin and subcutaneous tissue
Disorders

154 (22.1) 192 (27.1) 457 (27.5) 59 (46.4) 32 (17.0)

Gastrointestinal disorders

155 (22.2) 163 (22.4) 398 (23.5) 47 (36.7) 42 (22.8)
Female – N 437 436 1024 241 94

Any AE

364 (309.6) 341 (261.6) 828 (297.7) 134 (382.6) 82 (364.9)

Infections and infestations

232 (104.4) 232 (106.2) 544 (109.1) 58 (111.3) 54 (108.5)

Skin and subcutaneous tissue disorders

116 (40.8) 95 (31.4) 259 (39.0) 20 (33.3) 29 (45.2)

Gastrointestinal disorders

98 (32.7) 99 (33.3) 223 (32.7) 30 (51.7) 26 (39.2)

IR=incidence rate per 100 patient-years
Source: FDA Clinical Review,Table 46

Table 10. Exposure-adjusted incidence of adverse events by race (52-week treatment period) most frequent SOCs


Race subgroup
COSENTYX 150 mg
n (IR)
COSENTYX 300 mg
n (IR)
COSENTYX dose
n (IR)
Placebo
n (IR)
Biologic Active Comparator
n (IR)
Primary system organ class
Caucasian – N 1001 1017 2558 593 216

Any AE

757 (239.8) 795 (256.8) 1966 (265.4) 317 (383.6) 179 (291.4)

Infections and infestations

486 (92.8) 540 (103.6) 1274 (101.1) 140 (119.2) 131 (115.5)

Skin and subcutaneous tissue
disorders

167 (23.7) 190 (26.3) 496 (28.9) 53 (39.7) 41 (24.4)

Gastrointestinal disorders

189 (27.3) 202 (28.5) 487 (28.5) 61 (47.0) 50 (30.2)
Black – N 27 20 51 15 0

Any AE

21 (253.3) 13 (139.4) 37 (205.5) 5 (194.5) -

Infections and infestations

6 (34.1) 2 (14.3) 9 (27.1) 2 (62.7) -

Skin and subcutaneous tissue disorders

8 (50.7) 2 (14.0) 11 (34.3) 2 (53.4) -

Gastrointestinal disorders

2 (10.0) 1 (6.9) 3 (8.2) 0 (0.0) -
Asian – N 292 296 664 134 74

Any AE

228 (226.2) 221 (187.8) 508 (213.6) 60 (249.0) 47 (140.9)

Infections and infestations

117 (63.4) 115 (58.1) 262 (62.4) 20 (58.9) 25 (48.3)

Skin and subcutaneous tissue disorders

81 (39.8) 75 (34.3) 175 (37.6) 18 (53.0) 15 (26.2)

Gastrointestinal disorders

41 (17.5) 42 (17.2) 93 (17.7) 9 (24.9) 11 (18.9)
Native American – N 47 44 92 28 27

Any AE

39 (335.9) 32 (180.3) 72 (242.7) 13 (289.5) 22 (288.6)

Infections and infestations

22 (78.1) 23 (85.3) 46 (83.0) 1 (14.2) 9 (49.3)

Skin and subcutaneous tissue
Disorders

10 (28.9) 10 (28.6) 20 (28.6) 3 (44.0) 4 (17.8)

Gastrointestinal disorders

13 (40.5) 10 (29.0) 23 (34.3) 5 (74.1) 6 (28.2)
Pacific islander – N 2 5 7 2 1

Any AE

1 (89.7) 4 (172.1) 5 (145.4) 2 (7305.0) 1 (652.2)

Infections and infestations

1 (72.0) 3 (93.2) 4 (86.8) 0 (0.0) 1 (652.2)

Skin and subcutaneous tissue disorders

0 (0.0) 3 (118.6) 3 (69.9) 1 (405.8) 0 (0.0)

Gastrointestinal disorders

1 (89.7) 1 (26.0) 2 (40.3) 0 (0.0) 0 (0.0)
Other – N 22 24 50 19 4

Any AE

17 (305.3) 22 (481.5) 42 (375.2) 15 (450.2) 3 (225.0)

Infections and infestations

10 (89.8) 14 (136.2) 26 (114.7) 6 (80.8) 3 (119.0)

Skin and subcutaneous tissue disorders

3 (18.8) 5 (31.9) 8 (23.6) 2 (23.5) 1 (32.1)

Gastrointestinal disorders

5 (36.2) 5 (29.2) 10 (30.2) 2 (23.0) 1 (30.6)

IR=incidence rate per 100 patient-years
Source: FDA Clinical Review, Table 48

Table 11. Exposure-adjusted incidence of adverse events by age (52-week treatment period) most frequent SOCs


Age subgroup
COSENTYX 150 mg
n (IR)
COSENTYX 300 mg
n (IR)
COSENTYX dose
n (IR)
Placebo
n (IR)
Biologic Active Comparator
n (IR)
Primary system organ class
65 yr – N 1293 1311 3200 744 305

Any AE

991 (242.4) 1014 (237.5) 2462 (255.0) 389 (354.0) 238 (239.7)

Infections and infestations

604 (84.9) 659 (91.9) 1535 (91.9) 163 (102.1) 162 (91.3)

Skin and subcutaneous tissue
disorders

253 (27.8) 258 (27.3) 659 (30.3) 77 (43.9) 56 (23.4)

Gastrointestinal disorders

234 (25.1) 248 (26.0) 583 (26.2) 74 (42.4) 63 (26.3)
≥ 65 yr – N 102 99 230 49 18

Any AE

75 (211.4) 77 (219.5) 175 (225.8) 24 (320.2) 15 (322.9)

Infections and infestations

41 (71.3) 42 (72.4) 93 (71.4) 7 (67.8) 8 (92.2)

Skin and subcutaneous tissue
Disorders

17 (24.4) 29 (44.6) 57 (38.0) 2 (17.1) 5 (36.6)

Gastrointestinal disorders

19 (28.6) 14 (20.0) 38 (24.3) 3 (26.4) 5 (46.7)
≥ 75 yr – N 15 15 32 10 3

Any AE

11 (245.1) 12 (313.5) 25 (295.5) 6 (437.4) 2 (177.7)

Infections and infestations

6 (84.5) 5 (64.7) 12 (78.4) 1 (44.2) 2 (177.7)

Skin and subcutaneous tissue
disorders

5 (57.7) 2 (21.8) 8 (42.0) 2 (95.1) 0 (0.0)

Gastrointestinal disorders

2 (20.9) 4 (51.5) 6 (31.8) 0 (0.0) 0 (0.0)

IR=incidence rate per 100 patient-years
Source: FDA Clinical Review, Table 47


WHO WAS IN THE STUDIES?

Who participated in the clinical trials?

The FDA approved COSENTYX on evidence mainly from two clinical trials with a total of 2,044 adults who were diagnosed with plaque psoriasis that involved at least 10% of their body surface. The studies were conducted in North America, Central and South America, Europe, Asia, Central and South America, Africa, and Australia.

Figure 1 summarizes how many men and women were enrolled in the clinical trials used to evaluate efficacy.

Figure 1. Baseline Demographics by Sex

How many men and women were enrolled in the clinical trials used to evaluate efficacy of the drug COSENTYX.  In total, 1438 men (70%) and 606 women (30%) participated in the clinical trials used evaluate efficacy of the drug COSENTYX.
Source: Adapted from FDA Statistical Review, Table 8

Figure 2 and Table 1 summarize the percentage of patients by race enrolled in the clinical trials used to evaluate efficacy.

Figure 2. Baseline Demographics by Race

The percentage of patients by race enrolled in the clinical trials used to evaluate efficacy of the drug COSENTYX. In total, 1397 Caucasian (68.4%), 27 Black (1.3%), 443 Asian (21.7%), 117 Native American (5.7%), 7 Pacific Islander (0.3%), 5 where race data was missing (0.2%), and 47 patients who identified as other (2.3%) participated in the clinical trials used to evaluate efficacy of the drug COSENTYX.
Source: Adapted from FDA Statistical Review, Table 8

Table 1. Demographics of Safety Trials by Race

Race Number of Patients Percentage
Caucasian 1397 68.4%
Black 27 1.3%
Asian 443 21.7%
Native American 117 5.7%
Pacific Islander 7 0.3%
Unknown 5 0.2%
Other 47 2.3%

Source: Adapted from FDA Statistical Review, Table 8 

Who participated in the study?

COSENTYX was evaluated in two clinical trials, referred to as Trial 1 and Trial 2, for the treatment of moderate to severe plaque psoriasis in adult patients. The trial population for Trial 1 included 738 patients from 86 sites in 12 countries located in North America, Central and South America, Europe, and Asia. The population for Trial 2 included 1,306 patients from 154 sites in 23 countries located in North America (including the United States), Central and South America, Europe, Asia, Africa, and Australia. Patients in Trial 1 were randomized to receive either a lower dose of COSENTYX (150 mg), a higher dose of COSENTYX (300 mg), or a placebo. Patients in Trial 2 were randomized to receive either low-dose secukinumab, high-dose secukinumab, placebo, or a biologic active control.

Table 3. Baseline Demographics for the Pivotal Trials

  Trial 1 Trial 2
COSENTYX
300 mg
N=245
COSENTYX
150 mg
N=245
Placebo
N=248
COSENTYX
300 mg
N=327
COSENTYX
150 mg
N=327
Placebo
N=326
Biologic Active Control
N=326
Sex

Female

76 (31%) 77 (31%) 76 (31%) 103 (32%) 91 (28%) 89 (27%) 94 (29%)

Male

169 (69%) 168 (69%) 172 (69%) 224 (69%) 236 (72%) 237 (73%) 232 (71%)
Age

Mean

45 45 45 45 45 44 44

SD

14 13 13 13 13 13 13

Range

19-76 18-83 19-80 20-79 18-79 18-82 18-79

Median

45 45 45 45 45 44 44

<>

228 (93%) 223 (91%) 229 (92%) 305 (93%) 304 (93%) 311 (95%) 308 (94%)

≥65

17 (7%) 22 (9%) 19 (8%) 22 (7%) 23 (7%) 15 (5%) 18 (6%)
Race

Asian

52 (21%) 54 (22%) 46 (19%) 73 (22%) 72 (22%) 72 (22%) 74 (23%)

Black

4 (2%) 5 (2%) 10 (4%) 2 (1%) 3 (1%) 3 (1%) 0 (0%)

Caucasian

171 (70%) 171 (70%) 176 (71%) 224 (69%) 219 (67%) 217 (67%) 219 (67%)

Native
American

7 (3%) 5 (2%) 3 (1%) 22 (7%) 28 (9%) 25 (8%) 27 (8%)

Pacific Islander

3 (1%) 1 (0.4%) 0 (0%) 1 (0.3%) 0 (0%) 1 (0.3%) 1 (0.3%)

Other

6 (2%) 9 (4%) 13 (5%) 5 (2%) 5 (2%) 5 (2%) 4 (1%)

Unknown

2 (1%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 2 (0.6%) 1 (0.3%)

Extracted from FDA Statistical Review, Table 8

How was the study designed?

COSENTYX was approved by the FDA based primarily on two clinical trials with a total of 2,044 patients. Patients were randomly assigned to one of three treatment groups: one-third of patients were given a higher dose of COSENTYX, one-third was given a lower dose of COSENTYX, and one-third was given a placebo.  Neither the patients nor the health care professionals administering the drug knew which patients were in which group until after the drug trial was complete. Patients were evaluated for improvement of psoriasis after 12 weeks.

Safety evaluations of COSENTYX were based on four trials with a total of 2399 patients. One-third was given high-dose COSENTYX, one-third was given low-dose COSENTYX, and one-third was given low-dose COSENTYX.

Figure 3 summarizes how many men and women were enrolled in the clinical trials used to assess safety.

Figure 3. Demographics of Safety Trials by Sex

How many men and women were enrolled in the clinical trials used to evaluate safety of the drug COSENTYX.  In total, 1676 men (70%) and 723 women (30%) participated in the clinical trials used to evaluate safety of the drug COSENTYX.
Extracted from FDA Clinical Review, Table 17

Figure 4 and Table 2 summarize the percentage of patients by race enrolled in the clinical trials used to assess safety.

Figure 4. Demographics of Safety Trials by Race

The percentage of patients by race enrolled in the clinical trials used to evaluate safety of the drug COSENTYX. In total, 1730 Caucasian (72.1%), 35 Black (1.5%), 453 Asian (18.9%), 117 Native American (4.9%), 7 Pacific Islander (0.3%), 6 where race data was missing (0.3%), and 51 patients who identified as other (2.1%) participated in the clinical trials used to evaluate efficacy of the drug COSENTYX.
Extracted from FDA Clinical Review, Table 17

Table 2. Demographics of Safety Trials by Race

Race Number of Patients Percentage
Caucasian 1730 72.1%
Black 35 1.5%
Asian 453 18.9%
Native American 117 4.9%
Pacific Islander 7 0.3%
Unknown 6 0.3%
Other 51 2.1%

Source: Adapted from FDA Statistical Review, Table 8 

How was the study designed?

Efficacy of COSENTYX was evaluated in one randomized, placebo-controlled Phase 3 clinical trial (Trial 1) and one randomized, placebo-controlled and active-controlled trial (Trial 2). Clinical response was defined as both of the following:

  • The proportion of patients achieving a minimum 75% reduction in the  Psoriasis Area and Severity Index (PASI) score
  • The proportion of patients scoring 0 or 1 at Week 12 on the Investigator’s Global Assessment (IGA)

For Trial 2, low- and high-dose COSENTYX were additionally compared to the active-comparator for the same co-primary endpoints.

COSENTYX was primarily evaluated for safety in four randomized, placebo-controlled studies (Trials 1, 2, 3, and 4) through Week 12. Table 4 below provides a summary of the demographic data for the safety population.

Table 4. Demographics of subjects in Trials 1, 2, 3, and 4 through Week 12

Demographic variable COSENTYX
150 mg
N=692
COSENTYX
300 mg
N=690
Placebo
N=694
Biologic Active Control
N=323
Total
N=2399
Age group in years, n (%)

<>

634 (91.6) 642 (93.0) 651 (93.8) 305 (94.4) 2232 (93)

≥ 65

58 (8.4) 48 (7.0) 43 (6.2) 18 (5.6) 167 (7)

≥ 75

10 (1.4) 6 (0.9) 10 (1.4) 3 (0.9) 29 (1.2)
Age (years)

n

692 690 694 323 2399

Mean

45.1 44.9 44.7 43.8 44.8

SD

13.38 13.32 12.79 12.99 13.1

Median

45 45 45 44 45

Min - Max

18 - 83 18 - 83 18 - 82 18 - 79 18 - 83

Sex, n (%)

Female

207 (29.9) 214 (31) 208 (30) 94 (29.1) 723 (30.1)

Male

485 (70.1) 476 (69) 486 (70.0) 229 (70.9) 1676 (69.9)
Race, n (%)

Caucasian

499 (72.1) 504 (73) 511 (73.6) 216 (66.9) 1730 (72.1)

Black

13 (1.9) 9 (1.3) 13 (1.9) 0 (0.0) 35 (1.5)

Asian

129 (18.6) 129 (18.7) 121 (17.4) 74 (22.9) 453 (18.9)

Native American

33 (4.8) 29 (4.2) 28 (4.0) 27 (8.4) 117 (4.9)

Pacific Islander

1 (0.1) 4 (0.6) 1 (0.1) 1 (0.3) 7 (0.3)

Unknown

1 (0.1) 2 (0.3) 2 (0.3) 1 (0.3) 6 (0.3)

Other

16 (2.3) 13 (1.9) 18 (2.6) 4 (1.2) 51 (2.1)

Extracted from FDA Clinical Review, Table 17

What are the results of the efficacy study?

Approximately two-thirds of patients receiving the higher dose and approximately one-half of patients treated with the lower dose of COSENTYX achieved clear skin or almost clear skin during the first 12 weeks of treatment and maintained the response for a year.

What are the results of the trials used to assess safety?

The most common side effects that were seen more often than placebo were common cold, diarrhea, and upper respiratory tract infection.

Some infections were seen more frequently in patients treated with COSENTYX compared to those receiving placebo (28.7% compared to 18.9%). In patients with Crohn’s disease, worsening of the Crohn’s disease was observed in patients treated with COSENTYX. Allergic reactions, some serious, were seen in patients treated with COSENTYX.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

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