Plaque PsoriasisPhase 3NCT01646073
Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis
A Phase 3 study testing Adalimumab in people with Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 16 sites in China.
Trial summary
A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Adalimumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 425 participants
- Where
- 16 sitesChina
- Study dates
- Aug 2012to Dec 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of psoriasis for at least 6 months.
- Must have stable plaque psoriasis for at least 2 months before screening and baseline visits.
- Participant must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit.
- Participant must have moderate to severe plaque Psoriasis, defined by Body Surface Area involvement greater than or equal to 10% at the baseline visit.
- Participant must have a Physicians Global Assessment of at least moderate disease at baseline visit.
Who cannot join
- Diagnosis of other active skin diseases or skin infections.
- Participant has known hypersensitivity to adalimumab or it excipients.
- Participant has chronic recurring infections or active tuberculosis.
- Participant has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
- Participant is known to have immune deficiency or is immunocompromised.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Site Reference ID/Investigator# 72888
Beijing, 100034
Site Reference ID/Investigator# 72873
Beijing, 100044
Site Reference ID/Investigator# 72887
Beijing, 100730
Site Reference ID/Investigator# 85693
Chengdu, 610072
Site Reference ID/Investigator# 72976
Chongqing, 400038
Site Reference ID/Investigator# 72880
Dalian, 116011
Site Reference ID/Investigator# 72973
Guangzhou, 510120
Site Reference ID/Investigator# 72974
Guangzhou, 510630
Site Reference ID/Investigator# 72878
Hangzhou, Zhejiang, 310003
Site Reference ID/Investigator# 72877
Hangzhou, Zhejiang, 310009
Site Reference ID/Investigator# 87058
Jinan, 250012
Site Reference ID/Investigator# 72876
Shanghai, 200025
Site Reference ID/Investigator# 72875
Shanghai, 200433
Site Reference ID/Investigator# 72883
Shenyang, 110001
Site Reference ID/Investigator# 72977
Wuhan, Hubei, 430022
Site Reference ID/Investigator# 72975
Xi'an, 710032
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab (Humira®) in Chinese Subjects With Moderate to Severe Plaque Psoriasis
A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.
Read the detailed description
The purpose of this study is to evaluate the safety and efficacy of adalimumab and to determine how well it works in the treatment of adults with moderate to severe plaque psoriasis in the Chinese population. Psoriasis is a chronic immunologic disease characterized by marked inflammation and thickening of the epidermis that result in thick, scaly plaques involving the skin.
- Conditions
- Plaque Psoriasis
- Being tested
- Adalimumab, placebo
- Keywords
- Plaque Psoriasis, Psoriasis, Placebo Controlled, Skin Disease, Double Blind
- Medical subject headings
- Psoriasis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Also called ABT-D2E7, Humira
adalimumab eow
placeboBiological
placebo
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | Adalimumab 40 mg every other week (eow) Receives: Biological: Adalimumab |
| Placebo | Placebo comparator | placebo Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12
The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Measured: Week 12
Secondary outcomes (16)
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A]
The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI), other than Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Measured: Weeks 3 and 7
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B]
The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Measured: Weeks 16, 19, and 24
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A]
Psoriasis Area and Severity Index (PASI), is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Measured: Baseline to Week 12
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B]
PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Measured: Baseline to Week 24
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A]
The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Measured: Weeks 3, 7, and 12
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B]
The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
Measured: Weeks 16, 19, and 24
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A]
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'
Measured: Baseline and Weeks 3, 7, and 12
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period B]
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'
Measured: Weeks 16, 19, and 24
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A]
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'
Measured: Baseline and Weeks 3, 7, and 12
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period B]
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'
Measured: Weeks 16, 19, and 24
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A]
The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.
Measured: Baseline, Week 3, and Week 12
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period B]
The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.
Measured: Week 16 and Week 24
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A]
The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.
Measured: Baseline, Week 3, and Week 12
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period B]
The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.
Measured: Week 16 and Week 24
Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A]
Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.
Measured: Baseline to Week 12
Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B]
Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Okun, MD, Study chair, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646073
- Sponsor's protocol ID
- M13-606
- Status last verified
- Jan 2015
- First submitted
- 18 Jul 2012
- Last updated
- 19 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab (Humira®) in Chinese Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01646073
- Acronym / sponsor ID
- M13-606
- Conditions
- Plaque Psoriasis
- Keywords
- Plaque Psoriasis, Psoriasis, Placebo Controlled, Skin Disease, Double Blind
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Posted 19 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of adalimumab and to determine how well it works in the treatment of adults with moderate to severe plaque psoriasis in the Chinese population. Psoriasis is a chronic immunologic disease characterized by marked inflammation and thickening of the epidermis that result in thick, scaly plaques involving the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Biological: AdalimumabAdalimumab 40 mg every other week (eow) |
| Placebo | Placebo comparator | Biological: placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of psoriasis for at least 6 months.
- Must have stable plaque psoriasis for at least 2 months before screening and baseline visits.
- Participant must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit.
- Participant must have moderate to severe plaque Psoriasis, defined by Body Surface Area involvement greater than or equal to 10% at the baseline visit.
- Participant must have a Physicians Global Assessment of at least moderate disease at baseline visit.
Key exclusion criteria (5 listed)
- Diagnosis of other active skin diseases or skin infections.
- Participant has known hypersensitivity to adalimumab or it excipients.
- Participant has chronic recurring infections or active tuberculosis.
- Participant has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
- Participant is known to have immune deficiency or is immunocompromised.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: ABT-D2E7, Humiraadalimumab eow | Biological | Adalimumab |
| placeboplacebo | Biological | Placebo |
Primary outcome
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12
Time frame: Week 12
The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
16 secondary outcomes
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A]
Time frame: Weeks 3 and 7
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B]
Time frame: Weeks 16, 19, and 24
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A]
Time frame: Baseline to Week 12
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B]
Time frame: Baseline to Week 24
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A]
Time frame: Weeks 3, 7, and 12
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B]
Time frame: Weeks 16, 19, and 24
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A]
Time frame: Baseline and Weeks 3, 7, and 12
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period B]
Time frame: Weeks 16, 19, and 24
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A]
Time frame: Baseline and Weeks 3, 7, and 12
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period B]
Time frame: Weeks 16, 19, and 24
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A]
Time frame: Baseline, Week 3, and Week 12
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period B]
Time frame: Week 16 and Week 24
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A]
Time frame: Baseline, Week 3, and Week 12
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period B]
Time frame: Week 16 and Week 24
Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A]
Time frame: Baseline to Week 12
Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B]
Time frame: Baseline to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Okun, MD study chair
AbbVie
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab in people with Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.