Trial · NCT03512275
A Study of Bermekimab in Patients With Hidradenitis Suppurativa
NCT03512275, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2022-03-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Bermekimab in Patients With Hidradenitis Suppurativa. Trials, record NCT03512275. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03512275
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Bermekimab in Patients With Hidradenitis Suppurativa
- NCT number
- NCT03512275
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Bermekimab Monoclonal Antibody 400 mg
- First posted
- 2018-04-30
- Last updated
- 2022-03-14
- Results first posted
- 2022-03-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Up to Visit 14 (up to Day 93) | An adverse event is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical or biological agent under study. |
| Secondary | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Week 12 | Percentage of participants achieving HiSCR at Week 12 was reported. For this score participants were defined as achievers or non-achievers. The positive HiSCR score was defined as a greater than or equal to (\>=) 50% reduction in inflammatory lesion AN count (sum of abscesses and inflammatory nodules), and no increase in abscesses or draining fistulas in hidradenitis suppurativa compared with the lesions counted on visit 1 (baseline). |
| Secondary | Plasma Concentration of Bermekimab | Predose at Days 14 (Visit 3), 28 (Visit 5), 56 (Visit 9), 84 (Visit 13) | An enzyme-linked immunosorbent assay (ELISA) was developed to specifically measure bermekimab levels in human plasma. The blood samples were collected at each pharmacokinetic (PK) collection time point for PK analysis. |
| Secondary | Change From Baseline to Week 12 in Visual Analog Scale (VAS) Score for Disease | Baseline and Week 12 | Change from baseline in VAS score for disease was reported. The VAS is a validated, subjective measure for participants disease impression. Disease impression scores were recorded using a similar scale, with 0 representing "not at all severe" and 10 representing "extremely severe". |
| Secondary | Change From Baseline to Week 12 in VAS Score for Pain | Baseline and Week 12 | Change from baseline in VAS score for pain was reported. The VAS is a validated, subjective measure for acute and chronic pain. Pain scores were recorded by marking a number on a scale from 0 to 10, 0 representing "no pain" and 10 representing "extremely painful". |
| Secondary | Change From Baseline to Week 12 in Dermatology Life Quality Index (DLQI) Score | Baseline and Week 12 | The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of disease symptoms and treatment on Quality of life (QOL). The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 questions, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL. |
| Secondary | Change From Baseline to Week 12 in Physician's Global Assessment (PGA) Score | Baseline and Week 12 | PGA is a physician's assessment of the severity of disease based on a 6-point scale (Clear \[0\], minimal \[1\], mild \[2\], moderate \[3\], severe \[4\], more severe \[5\]) ranging from 0-5. Higher score indicated more severity of disease. |
| Secondary | Change From Baseline in Disease Activity Score (DAS) at Week 12 | Baseline and Week 12 | The DAS is the sum of scores of all affected areas of each participant. Each area was evaluated by the following formula: (the sum of the two largest diameters in each affected area in millimeter \[mm\]) \* (Total number of lesions in the anatomic area multiplied by the degree of inflammation of each lesion on a scale of 0 to 3). A minimum score of 0 and there is no maximum score range. Higher scores indicate more disease activity. |
| Secondary | Change From Baseline to Week 12 in Modified Sartorius Score (mSS) | Baseline and Week 12 | mSS is used to quantify severity of HS. Points are awarded for 12 body areas (left-right axillae, left - right sub/inframammary areas, intermammary area, left - right buttocks, left-right inguinocrural folds, perianal area, perineal area and other): points were awarded for nodules (2 points each);abscesses (4points);fistulas (4points);scars (1point); other findings (1 point); and longest distance between two lesions (no active lesion or only 1 lesion equal to \[=\]0 points, less than \[\<\]5cm=2points, 5-10cm=4points, greater than \[\>\]10cm 6points) and if lesions are separated by normal skin (yes-0 points; no-6points). Total mSS is sum of the 12 regional scores. Change from baseline in mSS was not reported as the electronic data capture (EDC) system erroneously requested data for this endpoint to be input in centimeters versus millimeters and conversion was not possible because it was given in ranges. Therefore, there was not enough valid data to sufficiently perform this endpoint analysis. |
| Secondary | Change From Baseline to Week 12 in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count | Baseline and Week 12 | Change from baseline to Week 12 in inflammatory lesion (abscesses and inflammatory nodules) count was reported. The sum of abscesses and inflammatory nodules was measured for each participant to assess change in inflammatory lesion counts. |
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 | Number of Participants With Adverse Events | Up to Visit 14 (up to Day 93) | The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Week 12 | The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated. | Percentage of Participants | NUMBER |
| SECONDARY | Plasma Concentration of Bermekimab | Predose at Days 14 (Visit 3), 28 (Visit 5), 56 (Visit 9), 84 (Visit 13) | The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated. Here, 'N' (number of participants analyzed) is defined as participants evaluable for this outcome measure. | micrograms per milliliter (mcg/mL) | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Visual Analog Scale (VAS) Score for Disease | Baseline and Week 12 | The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated. | Units on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in VAS Score for Pain | Baseline and Week 12 | The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated. | Units on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in Dermatology Life Quality Index (DLQI) Score | Baseline and Week 12 | The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated. | Units on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in Physician's Global Assessment (PGA) Score | Baseline and Week 12 | The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated. | Units on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity Score (DAS) at Week 12 | Baseline and Week 12 | The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated. | Units on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in Modified Sartorius Score (mSS) | Baseline and Week 12 | The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated. Data was not collected and analyzed for this outcome measure due to change in planned analysis. | ||
| SECONDARY | Change From Baseline to Week 12 in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count | Baseline and Week 12 | The safety analysis set (SAF) consisted of all participants that received at least one dose of study medication and were analyzed as treated. | Count of lesions | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 21 | Participants | ||
| Number of Participants With Adverse Events | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 16 | Participants | ||
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 62.5 | Percentage of Participants | ||
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 61.1 | Percentage of Participants | ||
| Plasma Concentration of Bermekimab | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | Visit 3 | 32.7 | Standard Deviation 18.3 | micrograms per milliliter (mcg/mL) |
| Plasma Concentration of Bermekimab | Group B: Bermekimab 400 mg (Anti-TNF Naive) | Visit 3 | 36.7 | Standard Deviation 22.7 | micrograms per milliliter (mcg/mL) |
| Plasma Concentration of Bermekimab | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | Visit 5 | 37.4 | Standard Deviation 20.7 | micrograms per milliliter (mcg/mL) |
| Plasma Concentration of Bermekimab | Group B: Bermekimab 400 mg (Anti-TNF Naive) | Visit 5 | 42.2 | Standard Deviation 25.0 | micrograms per milliliter (mcg/mL) |
| Plasma Concentration of Bermekimab | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | Visit 9 | 36.3 | Standard Deviation 20.9 | micrograms per milliliter (mcg/mL) |
| Plasma Concentration of Bermekimab | Group B: Bermekimab 400 mg (Anti-TNF Naive) | Visit 9 | 48.0 | Standard Deviation 31.7 | micrograms per milliliter (mcg/mL) |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 24 | |
| Overall Study | STARTED | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 18 | |
| Overall Study | COMPLETED | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 22 | |
| Overall Study | COMPLETED | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 11 | |
| Overall Study | NOT COMPLETED | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 2 | |
| Overall Study | NOT COMPLETED | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 7 |
Source ClinicalTrials.gov
Adverse events38
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 | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 0 | 24 | |
| other | Diarrhoea | Gastrointestinal disorders | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 1 | 18 | |
| other | Nausea | Gastrointestinal disorders | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 0 | 24 | |
| other | Nausea | Gastrointestinal disorders | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 2 | 18 | |
| other | Toothache | Gastrointestinal disorders | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 0 | 24 | |
| other | Toothache | Gastrointestinal disorders | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 1 | 18 | |
| other | Fatigue | General disorders | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 0 | 24 | |
| other | Fatigue | General disorders | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 1 | 18 | |
| other | Injection Site Erythema | General disorders | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 2 | 24 | |
| other | Injection Site Erythema | General disorders | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 0 | 18 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 0 | 24 |
| Total, all-cause mortality | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 0 | 18 |
| Total, other adverse events | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 6 | 24 |
| Total, other adverse events | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 8 | 18 |
| Total, serious adverse events | Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) | 2 | 24 |
| Total, serious adverse events | Group B: Bermekimab 400 mg (Anti-TNF Naive) | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32004568 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) vs Group B: Bermekimab 400 mg (Anti-TNF Naive): Number of Participants With Adverse Events | Trial comparisons |
| Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) vs Group B: Bermekimab 400 mg (Anti-TNF Naive): deaths from any cause | Trial comparisons |
| Group A: Bermekimab 400 Milligram (mg) (Anti-Tumor Necrosis Factor [TNF] Failed) vs Group B: Bermekimab 400 mg (Anti-TNF Naive): 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/NCT03512275
GET https://conductscience.org/api/trials/v1/NCT03512275/results?page=2