Trial · NCT01635764
Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa
NCT01635764, Phase 3, Completed, AbbVie (prior sponsor, Abbott); results first posted 2017-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa. Trials, record NCT01635764. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01635764
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa
- NCT number
- NCT01635764
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 508 participants, actual
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Conditions
- Hidradenitis Suppurativa
- Interventions
- adalimumab
- First posted
- 2012-07-10
- Last updated
- 2018-01-24
- Other registries' IDs
- eudract:2011-003478-98
- Results first posted
- 2017-09-05
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. |
| Primary | Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit | Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 | Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. |
| Primary | Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit | Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. |
| Primary | Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. |
| Primary | Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit | Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. |
| Primary | Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit | Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 | The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. |
| Primary | Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population | Baseline (in prior phase 3 study) to Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. |
| Primary | Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations | Baseline (in prior phase 3 study) to Entry of M12-555 and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. |
| Primary | Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population | Baseline (in prior phase 3 study) to Entry of Period B in prior phase 3 study and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 | The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. |
| Primary | Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3 | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | All participants with evaluable data at given time point. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit | Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 | All participants with evaluable data at given time point. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit | Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | All participants with evaluable data at given time point. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | All participants with evaluable data at given time point. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit | Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | All participants with evaluable data at given time point. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit | Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 | All participants with evaluable data at given time point. | percentage of participants | NUMBER |
| PRIMARY | Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population | Baseline (in prior phase 3 study) to Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | All participants with evaluable data at given time point. | units on a scale | MEAN |
| PRIMARY | Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations | Baseline (in prior phase 3 study) to Entry of M12-555 and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | All participants with evaluable data at given time point. | units on a scale | MEAN |
| PRIMARY | Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population | Baseline (in prior phase 3 study) to Entry of Period B in prior phase 3 study and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204 | All participants with evaluable data at given time point. | units on a scale | MEAN |
| PRIMARY | Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3 | Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 | All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point | percentage of participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group507
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | EW/EW/EW | Week 2 | 34.1 | percentage of participants | |
| Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | EW/EOW/EW | Week 2 | 39.8 | percentage of participants | |
| Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | EW/PBO/EW | Week 2 | 34.1 | percentage of participants | |
| Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | EW/EW/EW | Week 4 | 38.6 | percentage of participants | |
| Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | EW/EOW/EW | Week 4 | 41.1 | percentage of participants | |
| Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | EW/PBO/EW | Week 4 | 40.2 | percentage of participants | |
| Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | EW/EW/EW | Week 8 | 51.1 | percentage of participants | |
| Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | EW/EOW/EW | Week 8 | 48.9 | percentage of participants | |
| Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | EW/PBO/EW | Week 8 | 47.8 | percentage of participants | |
| Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit | EW/EW/EW | Week 12 | 52.3 | percentage of participants |
1 to 10 of 507Source ClinicalTrials.gov
See all 507 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adalimumab Every Week | 508 | |
| Overall Study | COMPLETED | Adalimumab Every Week | 235 | |
| Overall Study | NOT COMPLETED | Adalimumab Every Week | 273 |
Source ClinicalTrials.gov
Adverse events106
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 | DIARRHOEA | Gastrointestinal disorders | All Adalimumab | 33 | 508 | |
| other | NAUSEA | Gastrointestinal disorders | All Adalimumab | 32 | 508 | |
| other | PYREXIA | General disorders | All Adalimumab | 29 | 508 | |
| other | BRONCHITIS | Infections and infestations | All Adalimumab | 37 | 508 | |
| other | GASTROENTERITIS | Infections and infestations | All Adalimumab | 26 | 508 | |
| other | INFLUENZA | Infections and infestations | All Adalimumab | 40 | 508 | |
| other | NASOPHARYNGITIS | Infections and infestations | All Adalimumab | 92 | 508 | |
| other | SINUSITIS | Infections and infestations | All Adalimumab | 29 | 508 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | All Adalimumab | 84 | 508 | |
| other | URINARY TRACT INFECTION | Infections and infestations | All Adalimumab | 40 | 508 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Adalimumab | ||
| Total, other adverse events | All Adalimumab | 349 | 508 |
| Total, serious adverse events | All Adalimumab | 99 | 508 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01635764
GET https://conductscience.org/api/trials/v1/NCT01635764/results?page=2