Trial · NCT02672852
BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
NCT02672852, Phase 3, Completed, AbbVie; results first posted 2019-05-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment. Trials, record NCT02672852. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02672852
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
- NCT number
- NCT02672852
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 507 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Psoriasis
- Interventions
- Risankizumab, Placebo
- First posted
- 2016-02-03
- Last updated
- 2019-10-09
- Other registries' IDs
- eudract:2014-005102-38
- Results first posted
- 2019-05-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 | Baseline, Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data. |
| Primary | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 | Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Primary | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 | Week 52 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Secondary | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 | Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Secondary | Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 | Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Secondary | Percentage of Participants Achieving an sPGA Score of Clear at Week 16 | Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Secondary | Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | Week 16 | The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. NRI was used for missing data. |
| Secondary | Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104 | Week 104 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. |
| Secondary | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52 | Week 52 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
| Secondary | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52 | Week 52 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 | Baseline, Week 16 | Intent to treat (ITT) Population in Part A1(ITT\_A1): all participants who were randomized at Baseline. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 | Week 16 | ITT Population in Part A1(ITT\_A1) | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 | Week 52 | ITT Population in Part B for re-randomized participants (ITT\_B\_R): All participants who were randomized to Arm 1 at Baseline and re randomized at Week 28. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 | Week 16 | ITT Population in Part A1 (ITT\_A1) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 | Week 16 | ITT Population in Part A1 (ITT\_A1) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving an sPGA Score of Clear at Week 16 | Week 16 | ITT Population in Part A1 (ITT\_A1) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | Week 16 | ITT Population in Part A1 (ITT\_A1) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104 | Week 104 | ITT Population in Part B for re-randomized participants (ITT\_B\_R) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52 | Week 52 | ITT Population in Part B for re-randomized participants (ITT\_B\_R) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52 | Week 52 | ITT Population in Part B for re-randomized participants (ITT\_B\_R) | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 | Placebo (Part A1) | 2.0 | percentage of participants | ||
| Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 | Risankizumab (Part A1) | 73.2 | percentage of participants | ||
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 | Placebo (Part A1) | 7.0 | percentage of participants | ||
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 | Risankizumab (Part A1) | 83.5 | percentage of participants | ||
| Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 | Risankizumab/Placebo (Part B; Rerandomized Responders) | 61.3 | percentage of participants | ||
| Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 | Risankizumab/Risankizumab (Part B; Rerandomized Responders) | 87.4 | percentage of participants | ||
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 | Placebo (Part A1) | 8.0 | percentage of participants | ||
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 | Risankizumab (Part A1) | 88.7 | percentage of participants | ||
| Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 | Placebo (Part A1) | 1.0 | percentage of participants | ||
| Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 | Risankizumab (Part A1) | 47.2 | percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow63
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A1 | STARTED | Placebo (Part A1) | 100 | |
| Part A1 | STARTED | Risankizumab (Part A1) | 407 | |
| Part A1 | STARTED | Placebo/Risankizumab Part A2/Part B | 0 | |
| Part A1 | STARTED | Risankizumab/Risankizumab Part A2 | 0 | |
| Part A1 | STARTED | Risankizumab/Placebo (Part B; Rerandomized Responders) | 0 | |
| Part A1 | STARTED | Risankizumab/Risankizumab (Part B; Rerandomized Responders) | 0 | |
| Part A1 | STARTED | Risankizumab/Risankizumab Part B (Nonresponders) | 0 | |
| Part A1 | COMPLETED | Placebo (Part A1) | 97 | |
| Part A1 | COMPLETED | Risankizumab (Part A1) | 403 | |
| Part A1 | COMPLETED | Placebo/Risankizumab Part A2/Part B | 0 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 participant flowAdverse events535
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Influenza | Infections and infestations | Placebo (Part A1) | 1 | 100 | 1 |
| other | Influenza | Infections and infestations | Risankizumab (Part A1) | 3 | 407 | 3 |
| other | Influenza | Infections and infestations | Risankizumab/Placebo (Part B; Rerandomized Responders) | 8 | 225 | 10 |
| other | Influenza | Infections and infestations | Risankizumab/Risankizumab (Part B; Rerandomized Responders) | 7 | 111 | 8 |
| other | Influenza | Infections and infestations | Any Risankizumab | 22 | 500 | 24 |
| other | Nasopharyngitis | Infections and infestations | Placebo (Part A1) | 6 | 100 | 6 |
| other | Nasopharyngitis | Infections and infestations | Risankizumab (Part A1) | 21 | 407 | 21 |
| other | Nasopharyngitis | Infections and infestations | Risankizumab/Placebo (Part B; Rerandomized Responders) | 45 | 225 | 53 |
| other | Nasopharyngitis | Infections and infestations | Risankizumab/Risankizumab (Part B; Rerandomized Responders) | 23 | 111 | 36 |
| other | Nasopharyngitis | Infections and infestations | Any Risankizumab | 116 | 500 | 170 |
1 to 10 of 535Source ClinicalTrials.gov
See all 535 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Part A1) | 0 | 100 |
| Total, all-cause mortality | Risankizumab (Part A1) | 0 | 407 |
| Total, all-cause mortality | Risankizumab/Placebo (Part B; Rerandomized Responders) | 0 | 225 |
| Total, all-cause mortality | Risankizumab/Risankizumab (Part B; Rerandomized Responders) | 2 | 111 |
| Total, all-cause mortality | Any Risankizumab | 4 | 500 |
| Total, other adverse events | Placebo (Part A1) | 17 | 100 |
| Total, other adverse events | Risankizumab (Part A1) | 52 | 407 |
| Total, other adverse events | Risankizumab/Placebo (Part B; Rerandomized Responders) | 92 | 225 |
| Total, other adverse events | Risankizumab/Risankizumab (Part B; Rerandomized Responders) | 52 | 111 |
| Total, other adverse events | Any Risankizumab | 242 | 500 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02672852
GET https://conductscience.org/api/trials/v1/NCT02672852/results?page=2