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This is a randomized, double blind, multicenter study in patients with moderate to severe chronic hidradenitis suppurativa in parallel groups, to determine the efficacy and safety of multiple doses of CJM112 in comparison to placebo. The study has two periods to explore preliminary dose effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: CJM112 High Dose | Experimental | Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses |
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| Period 1: Placebo | Placebo Comparator | Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses |
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| Period 2: CJM112 High Dose (Period 1) / Placebo (Period 2) | Placebo Comparator | Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on CJM112 High Dose in Period 1 |
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| Period 2: Placebo (Period 1)/CJM112 Low Dose (Period 2) | Experimental | Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on Placebo in Period 1 |
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| Period 2: Placebo (Period 1)/CJM112 High Dose (Period 2) | Experimental | Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on Placebo in Period 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJM112 | Biological | CJM112 Fully human IgG1 monoclonal antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Responder Rate at Period 1: Week 16 | Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score An HS-PGA responder in period 1 was a participant who had an initial HS-PGA score of at least 3 at baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12 | Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score A HS-PGA responder in Period 1 is a study participant who had an initial HS-PGA score of at least 3 at Baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| R Hunger | University of Bern, Switzerland | Principal Investigator |
| Lars French | Zurich University Hospital, Switzerland | Principal Investigator |
| E P Prens | Erasmus MC, Rotterdam, Netherlands | Principal Investigator |
| Gregor Jemec | Dermatologisk Afdeling, Roskilde, Denmark | Principal Investigator |
| Sylke Schneider-Burrus | Psoriasis Research and Treatment Center, Charité hospital, Berlin, Germany | Principal Investigator |
| Christos C Zouboulis | Dessau Medical Center, Department of Dermatology, Venerology, Allergology and Immunology, Germany | Principal Investigator |
| Falk G Bechara | Ruhr-University Bochum, Germany | Principal Investigator |
| Barbara Horváth | University Medical Center Groningen, NL | Principal Investigator |
| Jan Mekkes | Dermatologie AMC, Amsterdam, NL |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Los Angeles | California | 90045 | United States | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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A total of 66 patients were enrolled, randomized and entered into two sequential periods (Period 1 and Extension Period 2) of which 60 patients completed Week 16 in Period 1 and entered Extension Period 2.
Study with 4 wks screening,two sequential treatment periods 16 wks (Period 1 & Extension Period 2)& 12 wks Follow-up. Randomization 2:1:1 to three sequences:Seq. 1: Period 1: CJM112 High Dose sc then Period 2: placebo sc; Seq. 2: Period 1: Placebo sc then Period 2: CJM112 Low Dose sc; Seq, 3: Period 1: Placebo sc then Period 2: CJM112 High Dose sc
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| ID | Title | Description |
|---|---|---|
| FG000 | Period 1: CJM112 High Dose | Period 1: CJM112 300mg subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses |
| FG001 | Period 1: Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Placebo | Drug |
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| Week 2, 4, 8 and 12 |
| Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2 | Ctrough is the serum concentration that is just prior to the beginning of, or at the end, of a dosing interval (mass/volume) for Period 1 (week 16) and Period 2/End of Study (week 44) | Week 16 and Week 44 |
| Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study | T1/2 The terminal elimination half-life for Period 1 (Week 16) and Period 2/End of Study (Week 44) | Week 16 (period 1), Week 44 (End of Study Period 2) |
| Immunogenicity - Incidence of ADA-positive and ADA-negative in Participants With or Without Pre-existing Antibodies in Period 1 and Period 2/End of Study | Immunogenicity - Incidence of semi-quantitative determination of anti-CJM112 antibodies or ADAs. ADA-positive and ADA-negative in participants with or without pre-existing antibodies Period 1 (week 16) and Period 2/End of Study (week 44) | Week 16 (period 1), Week 44 (End of Study Period 2) |
| Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2 | Total Interleukin-17A (IL-17A homodimer) in serum at Pre-dose Period 1 (Day 1) & Pre-dose Period 2 (Day 113) and Post-dose Period 1 (Day 99) and Post-dose Period 2 (Day 211) | Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211) |
| Christian Vestergaard | Dermato-verenologisk afdeling S, Denmark | Principal Investigator |
| Ormond Beach |
| Florida |
| 32174 |
| United States |
| Novartis Investigative Site | Tampa | Florida | 33609 | United States |
| Novartis Investigative Site | Atlanta | Georgia | 30342 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46256 | United States |
| Novartis Investigative Site | Rockville | Maryland | 20850 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02114 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68144 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37215 | United States |
| Novartis Investigative Site | Roskilde | 4000 | Denmark |
| Novartis Investigative Site | Berlin | 10098 | Germany |
| Novartis Investigative Site | Bochum | 44791 | Germany |
| Novartis Investigative Site | Groningen | Netherlands |
| Novartis Investigative Site | Rotterdam | 3015 CE | Netherlands |
| Novartis Investigative Site | Basel | Switzerland |
| Novartis Investigative Site | Zurich | CH-8091 | Switzerland |
Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
| FG002 | Extension Period 2: CJM112 High Dose /Placebo | Extension Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on CJM112 High Dose in Period 1 |
| FG003 | Extension Period 2: Placebo/CJM112 Low Dose | Extension Period 2: CJM112 50mg subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1 |
| FG004 | Extension Period 2: Placebo/CJM112 High Dose | Extension Period 2: CJM112 300mg subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1 |
| PD Analysis Set Period 1 |
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| PK Analysis Set Period 1 |
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| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Period 1: CJM112 High Dose | Period 1: CJM112 300mg subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses |
| BG001 | Period 1: Placebo | Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Clinical Responder Rate at Period 1: Week 16 | Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score An HS-PGA responder in period 1 was a participant who had an initial HS-PGA score of at least 3 at baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe. | PD analysis set 1 includes all patients who were CJM112-treated or placebo-treated in Period 1 with available PD data and no protocol deviations with relevant impact on PD data in Period 1. | Posted | Number | participants | Week 16 |
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| Secondary | Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12 | Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score A HS-PGA responder in Period 1 is a study participant who had an initial HS-PGA score of at least 3 at Baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe. | PD analysis set 1 includes all patients who were CJM112-treated or placebo-treated in Period 1 with available PD data and no protocol deviations with relevant impact on PD data in Period 1. | Posted | Number | count of participants | Week 2, 4, 8 and 12 |
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| Secondary | Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2 | Ctrough is the serum concentration that is just prior to the beginning of, or at the end, of a dosing interval (mass/volume) for Period 1 (week 16) and Period 2/End of Study (week 44) | PK analysis set 1 includes all patients who were CJM112-treated in Period 1 with available PK data & no protocol deviations with relevant impact on PK data. PK analysis set 2 & 3 includes all patients from safety analysis set 2 & set 3 with available PK data & no protocol deviations with relevant impact on PK data for Period 2/End of Study. | Posted | Mean | Standard Deviation | ug/mL | Week 16 and Week 44 |
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| Secondary | Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study | T1/2 The terminal elimination half-life for Period 1 (Week 16) and Period 2/End of Study (Week 44) | PK analysis set 1 includes all patients who were CJM112-treated in Period 1 with available PK data & no protocol deviations with relevant impact on PK data. PK analysis set 2 & 3 includes all patients from safety analysis set 2 & set 3 with available PK data & no protocol deviations with relevant impact on PK data for Period 2/End of Study. | Posted | Mean | Standard Deviation | days | Week 16 (period 1), Week 44 (End of Study Period 2) |
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| Secondary | Immunogenicity - Incidence of ADA-positive and ADA-negative in Participants With or Without Pre-existing Antibodies in Period 1 and Period 2/End of Study | Immunogenicity - Incidence of semi-quantitative determination of anti-CJM112 antibodies or ADAs. ADA-positive and ADA-negative in participants with or without pre-existing antibodies Period 1 (week 16) and Period 2/End of Study (week 44) | PK analysis set 1 includes all patients who were CJM112-treated in Period 1 with available PK data & no protocol deviations with relevant impact on PK data. PK analysis set 2 & 3 includes all patients from safety analysis set 2 & set 3 with available PK data & no protocol deviations with relevant impact on PK data for Period 2/End of Study. | Posted | Number | participants | Week 16 (period 1), Week 44 (End of Study Period 2) |
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| Secondary | Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2 | Total Interleukin-17A (IL-17A homodimer) in serum at Pre-dose Period 1 (Day 1) & Pre-dose Period 2 (Day 113) and Post-dose Period 1 (Day 99) and Post-dose Period 2 (Day 211) | PK analysis set 1 includes all patients who were CJM112-treated in Period 1 with available PK data & no protocol deviations with relevant impact on PK data. PK analysis set 2 & 3 includes all patients from safety analysis set 2 & set 3 with available PK data & no protocol deviations with relevant impact on PK data for Period 2/End of Study. | Posted | Mean | Standard Deviation | pg/mL | Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211) |
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Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit - End of Study Week 44.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1: CJM112 High Dose | Period 1: CJM112 300mg subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses | 0 | 33 | 25 | 33 | ||
| EG001 | Period 1: Placebo | Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses | 1 | 33 | 23 | 33 | ||
| EG002 | Extension Period 2: CJM112 High Dose /Placebo | Extension Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on CJM112 High Dose in Period 1 | 1 | 29 | 20 | 29 | ||
| EG003 | Extension Period 2: Placebo/CJM112 Low Dose | Extension Period 2: CJM112 50mg subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1 | 0 | 16 | 13 | 16 | ||
| EG004 | Extension Period 2: Placebo/CJM112 High Dose | Extension Period 2: CJM112 300mg subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1 | 0 | 15 | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Groin abscess | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
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| Sudden hearing loss | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (19.1) | Systematic Assessment |
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| Eyelid cyst | Eye disorders | MedDRA (19.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Pain | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Abscess | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Eyelid infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Periorbital cellulitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Tinea versicolour | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA (19.1) | Systematic Assessment |
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| QRS axis abnormal | Investigations | MedDRA (19.1) | Systematic Assessment |
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| White blood cells urine | Investigations | MedDRA (19.1) | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Pruritus genital | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single- site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 8627788300 |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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| Lost to Follow-up |
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| Patient/guardian decision |
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| Male |
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Extension Period 2: CJM112 300mg subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1 |
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Extension Period 2: CJM112 300mg subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses this group. This group was on Placebo in Period 1
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