Trial · NCT02808975
Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically
NCT02808975, Phase 4, Completed, AbbVie; results first posted 2020-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically. Trials, record NCT02808975. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02808975
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically
- NCT number
- NCT02808975
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 206 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Hidradenitis Suppurativa (HS)
- Interventions
- Placebo, Adalimumab
- First posted
- 2016-06-22
- Last updated
- 2020-05-14
- Other registries' IDs
- eudract:2015-005161-23
- Results first posted
- 2020-05-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | At Week 12 | HiSCR is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline. |
| Secondary | Percentage of Participants Achieving HiSCR-es at Week 12 | At Week12 | Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site. |
| Secondary | Percentage of Participants Achieving HiSCR-es at Week 24 | At Week 24 | Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site. |
| Secondary | Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12 | From Baseline to Week 12 | The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented. |
| Secondary | Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery | At Week 12 | The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented, and the percentage of participants at Week 12 requiring a less extensive surgery than the surgical plan (determined at Baseline) or no surgery as determined by the designated surgeon was recorded. |
Source ClinicalTrials.gov
Outcomes5
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 Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | At Week 12 | Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit; non-responder imputation (NRI) was used for missing data | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving HiSCR-es at Week 12 | At Week12 | Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit; non-responder imputation (NRI) was used for missing data | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving HiSCR-es at Week 24 | At Week 24 | Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit; non-responder imputation (NRI) was used for missing data | percentage of participants | NUMBER |
| SECONDARY | Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12 | From Baseline to Week 12 | Observed case (OC) analysis was performed on the intent-to-treat (ITT) population. The ITT population consisted of all participants who were randomized at the Baseline visit. | percent change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery | At Week 12 | Observed case (OC) analysis was performed on the intent-to-treat (ITT) population. The ITT population consisted of all participants who were randomized at the Baseline visit. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
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 Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Placebo | 34.0 | 95% Confidence Interval 24.8 to 43.1 | percentage of participants | |
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Adalimumab | 47.6 | 95% Confidence Interval 37.9 to 57.2 | percentage of participants | |
| Percentage of Participants Achieving HiSCR-es at Week 12 | Placebo | 35.0 | 95% Confidence Interval 25.7 to 44.2 | percentage of participants | |
| Percentage of Participants Achieving HiSCR-es at Week 12 | Adalimumab | 47.6 | 95% Confidence Interval 37.9 to 57.2 | percentage of participants | |
| Percentage of Participants Achieving HiSCR-es at Week 24 | Placebo | 31.1 | 95% Confidence Interval 22.1 to 40.0 | percentage of participants | |
| Percentage of Participants Achieving HiSCR-es at Week 24 | Adalimumab | 51.5 | 95% Confidence Interval 41.8 to 61.1 | percentage of participants | |
| Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12 | Placebo | 26.233 | 95% Confidence Interval -31.684 to 84.150 | percent change from Baseline | |
| Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12 | Adalimumab | 68.190 | 95% Confidence Interval 8.485 to 127.896 | percent change from Baseline | |
| Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery | Placebo | 43.7 | 95% Confidence Interval 33.3 to 54.1 | percentage of participants | |
| Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery | Adalimumab | 46.3 | 95% Confidence Interval 35.5 to 57.1 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 103 | |
| Overall Study | STARTED | Adalimumab | 103 | |
| Overall Study | COMPLETED | Placebo | 81 | |
| Overall Study | COMPLETED | Adalimumab | 84 | |
| Overall Study | NOT COMPLETED | Placebo | 22 | |
| Overall Study | NOT COMPLETED | Adalimumab | 19 |
Source ClinicalTrials.gov
Adverse events34
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 | Placebo | 4 | 103 | 4 |
| other | DIARRHOEA | Gastrointestinal disorders | Adalimumab | 6 | 103 | 6 |
| other | NASOPHARYNGITIS | Infections and infestations | Placebo | 19 | 103 | 24 |
| other | NASOPHARYNGITIS | Infections and infestations | Adalimumab | 19 | 103 | 23 |
| other | PROCEDURAL PAIN | Injury, poisoning and procedural complications | Placebo | 8 | 103 | 9 |
| other | PROCEDURAL PAIN | Injury, poisoning and procedural complications | Adalimumab | 14 | 103 | 14 |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | Placebo | 1 | 103 | 1 |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | Adalimumab | 6 | 103 | 6 |
| other | DIZZINESS | Nervous system disorders | Placebo | 6 | 103 | 7 |
| other | DIZZINESS | Nervous system disorders | Adalimumab | 2 | 103 | 2 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 103 |
| Total, all-cause mortality | Adalimumab | 2 | 103 |
| Total, other adverse events | Placebo | 43 | 103 |
| Total, other adverse events | Adalimumab | 48 | 103 |
| Total, serious adverse events | Placebo | 3 | 103 |
| Total, serious adverse events | Adalimumab | 7 | 103 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34406349 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adalimumab vs Placebo: deaths from any cause | Trial comparisons |
| Adalimumab vs Placebo: serious adverse events | Trial comparisons |
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/NCT02808975
GET https://conductscience.org/api/trials/v1/NCT02808975/events?page=2