Trial · NCT02421172

Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients

NCT02421172, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2019-05-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients. Trials, record NCT02421172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02421172

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy, Safety, and Pharmacokinetics Study of CJM112 in Hidradenitis Suppurativa Patients
NCT number: NCT02421172
Status: Completed
Phases: Phase 2
Enrollment: 66 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Hidradenitis Suppurativa (Acne Inversa)
Interventions: CJM112, Placebo
First posted: 2015-04-20
Last updated: 2022-07-13
Results first posted: 2019-05-23

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clinical Responder Rate at Period 1: Week 16	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.
Secondary	Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12	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.
Secondary	Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2	Week 16 and Week 44	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)
Secondary	Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study	Week 16 (period 1), Week 44 (End of Study Period 2)	T1/2 The terminal elimination half-life for Period 1 (Week 16) and Period 2/End of Study (Week 44)
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	Week 16 (period 1), Week 44 (End of Study Period 2)	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)
Secondary	Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2	Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211)	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)

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical Responder Rate at Period 1: Week 16	Week 16	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.	participants	NUMBER
SECONDARY	Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12	Week 2, 4, 8 and 12	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.	count of participants	NUMBER
SECONDARY	Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2	Week 16 and 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.	ug/mL	MEAN
SECONDARY	Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study	Week 16 (period 1), Week 44 (End of Study Period 2)	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.	days	MEAN
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	Week 16 (period 1), Week 44 (End of Study Period 2)	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.	participants	NUMBER
SECONDARY	Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2	Pre-dose (Period 1 Day 1 & Period 2 Day 113), 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.	pg/mL	MEAN

Source ClinicalTrials.gov

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Clinical Responder Rate at Period 1: Week 16	Period 1: CJM112 High Dose		10	participants
Clinical Responder Rate at Period 1: Week 16	Period 1: Placebo		4	participants
Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12	Period 1: CJM112 High Dose	Week 2	4	count of participants
Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12	Period 1: Placebo	Week 2	3	count of participants
Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12	Period 1: CJM112 High Dose	Week 4	6	count of participants
Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12	Period 1: Placebo	Week 4	3	count of participants
Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12	Period 1: CJM112 High Dose	Week 8	5	count of participants
Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12	Period 1: Placebo	Week 8	6	count of participants
Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12	Period 1: CJM112 High Dose	Week 12	7	count of participants
Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12	Period 1: Placebo	Week 12	4	count of participants

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow40

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1	STARTED	Period 1: CJM112 High Dose	33
Period 1	STARTED	Period 1: Placebo	33
Period 1	STARTED	Extension Period 2: CJM112 High Dose /Placebo	0
Period 1	STARTED	Extension Period 2: Placebo/CJM112 Low Dose	0
Period 1	STARTED	Extension Period 2: Placebo/CJM112 High Dose	0
Period 1	PD Analysis Set Period 1	Period 1: CJM112 High Dose	31
Period 1	PD Analysis Set Period 1	Period 1: Placebo	33
Period 1	PD Analysis Set Period 1	Extension Period 2: CJM112 High Dose /Placebo	0
Period 1	PD Analysis Set Period 1	Extension Period 2: Placebo/CJM112 Low Dose	0
Period 1	PD Analysis Set Period 1	Extension Period 2: Placebo/CJM112 High Dose	0

1 to 10 of 40Source ClinicalTrials.gov

See all 40 participant flow

Adverse events295

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
other	Ear pain	Ear and labyrinth disorders	Period 1: CJM112 High Dose	1	33
other	Ear pain	Ear and labyrinth disorders	Period 1: Placebo	0	33
other	Ear pain	Ear and labyrinth disorders	Extension Period 2: CJM112 High Dose /Placebo	0	29
other	Ear pain	Ear and labyrinth disorders	Extension Period 2: Placebo/CJM112 Low Dose	0	16
other	Ear pain	Ear and labyrinth disorders	Extension Period 2: Placebo/CJM112 High Dose	1	15
other	Sudden hearing loss	Ear and labyrinth disorders	Period 1: CJM112 High Dose	0	33
other	Sudden hearing loss	Ear and labyrinth disorders	Period 1: Placebo	0	33
other	Sudden hearing loss	Ear and labyrinth disorders	Extension Period 2: CJM112 High Dose /Placebo	0	29
other	Sudden hearing loss	Ear and labyrinth disorders	Extension Period 2: Placebo/CJM112 Low Dose	1	16
other	Sudden hearing loss	Ear and labyrinth disorders	Extension Period 2: Placebo/CJM112 High Dose	0	15

1 to 10 of 295Source ClinicalTrials.gov

See all 295 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Period 1: CJM112 High Dose
Total, all-cause mortality	Period 1: Placebo
Total, all-cause mortality	Extension Period 2: CJM112 High Dose /Placebo
Total, all-cause mortality	Extension Period 2: Placebo/CJM112 Low Dose
Total, all-cause mortality	Extension Period 2: Placebo/CJM112 High Dose
Total, other adverse events	Period 1: CJM112 High Dose	25	33
Total, other adverse events	Period 1: Placebo	23	33
Total, other adverse events	Extension Period 2: CJM112 High Dose /Placebo	20	29
Total, other adverse events	Extension Period 2: Placebo/CJM112 Low Dose	13	16
Total, other adverse events	Extension Period 2: Placebo/CJM112 High Dose	14	15

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Period 1: CJM112 High Dose vs Period 1: Placebo: Clinical Responder Rate at Period 1: Week 16

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02421172

GET https://conductscience.org/api/trials/v1/NCT02421172/results?page=2

API reference For AI assistants