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Phase 4 Completed N=80 Treatment

Study to Evaluate the Efficacy of Etanercept Treatment in Adults Who Failed Therapy With Apremilast

Source: ClinicalTrials.gov NCT02749370 ↗
Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Aug 2018
Primary outcomePrimary: Percentage of Participants With a PASI 75 Response at Week 12 — 41.6 percentage of participants
◆ Published Evidence
Emerging
7citations · ~1 / year
Open-Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast.
Journal of drugs in dermatology : JDD · 2018 · Likely link

Summary

To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).

Linked Publications

  • Open-Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast.
    Journal of drugs in dermatology : JDD · 2018 · 7 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With a PASI 75 Response at Week 12
41.6
SECONDARY
Percentage of Participants With a PASI 75 Response at Each Visit
6.6; 23.4; 41.6; 42.9; 42.9; 45.5
SECONDARY
Percentage of Participants With a PASI 50 Response at Each Visit
23.7; 50.6; 70.1; 68.8; 74.0; 62.3
SECONDARY
Percentage of Participants With a PASI 90 Response at Each Visit
1.3; 6.5; 13.0; 16.9; 23.4; 22.1
SECONDARY
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
22.03; 43.51; 55.47; 57.41; 60.42; 57.67
SECONDARY
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
3.9; 15.6; 23.4; 28.6; 29.9; 33.8
SECONDARY
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
21.1; 55.8; 62.3; 59.7; 55.8; 57.1
SECONDARY
Static Physician Global Assessment (sPGA) at Each Visit
2.9; 2.4; 2.2; 2.2; 2.2; 2.2
SECONDARY
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
40.8; 70.1; 75.3; 72.7; 74.0; 74.0
SECONDARY
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
7.9; 31.2; 32.5; 37.7; 36.4; 39.0
SECONDARY
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit
13.47; 31.03; 44.49; 48.26; 49.97; 46.89
SECONDARY
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
14.7; 13.7; 12.1; 11.7; 10.0; 8.8
SECONDARY
PSI "Itch From Psoriasis" Component Score at Each Visit
2.2; 2.0; 1.9; 1.8; 1.5; 1.3
SECONDARY
PSI "Redness of Skin Lesions" Component Score at Each Visit
2.4; 2.2; 2.0; 1.8; 1.7; 1.5
SECONDARY
PSI "Scaling of Skin Lesions" Component Score at Each Visit
2.3; 2.1; 1.9; 1.9; 1.6; 1.5
SECONDARY
PSI "Burning of Skin Lesions" Component Score at Each Visit
1.3; 1.2; 1.0; 1.0; 0.8; 0.8
SECONDARY
PSI "Stinging of Skin Lesions" Component Score at Each Visit
1.2; 1.1; 1.0; 1.0; 0.8; 0.7
SECONDARY
PSI "Cracking of Skin Lesions" Component Score at Each Visit
1.9; 1.7; 1.6; 1.4; 1.2; 1.1
SECONDARY
PSI "Flaking of Skin Lesions" Component Score at Each Visit
2.2; 2.1; 1.8; 1.8; 1.5; 1.3
SECONDARY
PSI "Pain From Skin Lesions" Component Score at Each Visit
1.2; 1.2; 1.0; 1.0; 0.8; 0.7
SECONDARY
Patient Assessment of Treatment Satisfaction at Week 12
4.1; 13.5; 21.6; 32.4; 28.4
SECONDARY
Patient Assessment of Treatment Satisfaction at Week 24
8.0; 25.3; 13.3; 24.0; 29.3
SECONDARY
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24
53.60; 36.95
SECONDARY
Number of Participants With Adverse Events
19; 2; 2; 0; 10; 1

Eligibility Criteria

Inclusion Criteria

  • Subject has provided informed consent prior to initiation of any study specific activities/procedures
  • Male or female subject is ≥ 18 years of age at time of screening
  • Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator
  • Subject has moderate to severe plaque psoriasis (PsO) with involved body surface area (BSA) ≥ 10%, psoriasis area and severity index (PASI) ≥ 10 and static physician's global assessment (sPGA) ≥ 3 at screening and baseline
  • Subject is currently receiving treatment with apremilast for moderate to severe plaque PsO or subject has discontinued treatment with apremilast for PsO within the past 3 months prior to screening
  • Subject has failed therapy with apremilast for moderate to severe plaque PsO defined as either (1) failure to achieve adequate clinical response in the opinion of the investigator, (2) loss of adequate clinical response in the opinion of the investigator or (3) intolerability to apremilast in the opinion of the investigator
  • Subject has received at least 4 weeks of apremilast treatment for moderate to severe plaque PsO (this only applies for subjects who are qualifying by failure to achieve adequate clinical response or loss of adequate clinical response, this does not apply for subjects who are qualifying by intolerability to apremilast)
  • Subject has not had significant known weight increase or decrease (≥ 10%) during apremilast treatment
  • Subject is < 264 lbs at screening and baseline -Subject has a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody
  • Subject has no known history of tuberculosis.

Exclusion Criteria

Skin disease related

-Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions at the time of the screening visit (for example, eczema) that would interfere with evaluations of the effect of investigational product on PsO.

Other Medical Conditions

  • Subject has one or more significant concurrent medical conditions per investigator judgment, including the following
  • Poorly controlled diabetes
  • Chronic kidney disease stage IIIb, IV, or V
  • Symptomatic heart failure (New York Heart Association class II, III, or IV)
  • Myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
  • Uncontrolled hypertension
  • Severe chronic pulmonary disease (eg, requiring oxygen therapy)
  • Multiple sclerosis or any other demyelinating disease
  • Liver disease
  • Anemia
  • Major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis (for example, systemic lupus erythematosus with the exception of secondary Sjogren's syndrome)
  • Subject has active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, Merkel cell carcinoma or history of cancer (other than fully resected and surgically cured cutaneous basal cell and squamous cell carcinoma) within 5 years before the first dose of investigational product.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02749370) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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