Hidradenitis Suppurativa (Acne Inversa)Phase 2NCT02421172

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

A Phase 2 study testing CJM112 in people with Hidradenitis Suppurativa (Acne Inversa), run by Novartis Pharmaceuticals at 16 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hidradenitis Suppurativa (Acne Inversa)
What is being tested?: CJM112
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 16 sitesin 5 countries
Study dates: 13 Apr 2015to 23 Nov 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male and female patients 18 to 65 years of age with clinically diagnosed chronic HS for at least 1 year (prior to screening) who have undergone previous antibiotic therapy
Weight between 50 kg and 150 kg
HS-PGA score of at least moderate severity at the time of inclusion with at least 4 abscesses and/or nodules. HS lesions must be present in at least two distinct anatomical areas, and at least one area must be minimally Hurley Stage II (moderate)

Who cannot join

Use of previous biologics or other specified concomitant medications
Use of any systemic treatment for HS in the last 4 weeks prior to randomization
Presence of more than 25 draining fistulae.
Surgical treatment for HS in the last 4 weeks prior to randomization/first treatment.
Women of child-bearing potential and sexually active males unwilling to use a condom during intercourse while taking drug and for 15 weeks after stopping investigational medication.
Evidence of active tuberculosis at screening

Show all 10Show fewer

History of severe systemic Candida infections or evidence of Candidiasis in the last two weeks
Active systemic or skin infections (other than common cold or HS related) during the two weeks before randomization/first treatment
Any live vaccines (including nasal spray flu vaccine) starting from 6 weeks before randomization.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

16 sites in 5 countries.

Country

City, postcode or hospital

16 sites in 5 countries

United States9 sites

Novartis Investigative Site
Atlanta, Georgia, 30342
Novartis Investigative Site
Boston, Massachusetts, 02114
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Los Angeles, California, 90045
Novartis Investigative Site
Nashville, Tennessee, 37215
Novartis Investigative Site
Omaha, Nebraska, 68144
Novartis Investigative Site
Ormond Beach, Florida, 32174
Novartis Investigative Site
Rockville, Maryland, 20850
Novartis Investigative Site
Tampa, Florida, 33609

Other trials in United States

Germany2 sites

Novartis Investigative Site
Berlin, 10098
Novartis Investigative Site
Bochum, 44791

Other trials in Germany

Netherlands2 sites

Novartis Investigative Site
Groningen
Novartis Investigative Site
Rotterdam, 3015 CE

Other trials in Netherlands

Switzerland2 sites

Novartis Investigative Site
Basel
Novartis Investigative Site
Zurich, CH-8091

Other trials in Switzerland

Denmark1 site

Novartis Investigative Site
Roskilde, 4000

Other trials in Denmark

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Multiple Dose Study to Evaluate the Clinical Efficacy, Safety, Tolerability, Dose Relation, Pharmacokinetics and Pharmacodynamics of CJM112 in Moderate to Severe Chronic Hidradenitis Suppurativa Patients

Conditions: Hidradenitis Suppurativa (Acne Inversa)
Being tested: CJM112, Placebo
Keywords: Hidradenitis Suppurativa
Medical subject headings: Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CJM112Biological
CJM112 Fully human IgG1 monoclonal antibody
PlaceboDrug

Study groups in NCT02421172
Study group	Role	What they receive
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 Receives: Biological: CJM112
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 Receives: Drug: Placebo
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 Receives: Drug: Placebo
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 Receives: Biological: CJM112
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 Receives: Biological: CJM112

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 16

Secondary outcomes (5)

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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 201523 Nov 2016

First posted20 Apr 2015 (estimated)
Study start13 Apr 2015
Primary completion23 Nov 2016
Study completion23 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hidradenitis Suppurativa (Acne Inversa)Studies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02421172
Sponsor's protocol ID: CCJM112X2202
Status last verified: Jun 2022
First submitted: 18 Mar 2015
Last updated: 13 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

All Hidradenitis Suppurativa (Acne Inversa) trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo Controlled, Multiple Dose Study to Evaluate the Clinical Efficacy, Safety, Tolerability, Dose Relation, Pharmacokinetics and Pharmacodynamics of CJM112 in Moderate to Severe Chronic Hidradenitis Suppurativa Patients
ClinicalTrials.gov ID: NCT02421172
Acronym / sponsor ID: CCJM112X2202
Conditions: Hidradenitis Suppurativa (Acne Inversa)
Keywords: Hidradenitis Suppurativa
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 13 Apr 2015 (actual)
Primary completion: 23 Nov 2016 (actual)
Study completion: 23 Nov 2016 (actual)
First posted: 20 Apr 2015 (estimated)
Results: Posted 23 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Period 1: CJM112 High Dose	Experimental	Biological: CJM112Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
Period 1: Placebo	Placebo comparator	Drug: PlaceboPeriod 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
Period 2: CJM112 High Dose (Period 1) / Placebo (Period 2)	Placebo comparator	Drug: PlaceboPeriod 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
Period 2: Placebo (Period 1)/CJM112 Low Dose (Period 2)	Experimental	Biological: CJM112Period 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
Period 2: Placebo (Period 1)/CJM112 High Dose (Period 2)	Experimental	Biological: CJM112Period 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

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Male and female patients 18 to 65 years of age with clinically diagnosed chronic HS for at least 1 year (prior to screening) who have undergone previous antibiotic therapy
Weight between 50 kg and 150 kg
HS-PGA score of at least moderate severity at the time of inclusion with at least 4 abscesses and/or nodules. HS lesions must be present in at least two distinct anatomical areas, and at least one area must be minimally Hurley Stage II (moderate)

Key exclusion criteria (10 listed)

Use of previous biologics or other specified concomitant medications
Use of any systemic treatment for HS in the last 4 weeks prior to randomization
Presence of more than 25 draining fistulae.
Surgical treatment for HS in the last 4 weeks prior to randomization/first treatment.
Women of child-bearing potential and sexually active males unwilling to use a condom during intercourse while taking drug and for 15 weeks after stopping investigational medication.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CJM112CJM112 Fully human IgG1 monoclonal antibody	Biological	Period 1: CJM112 High Dose, Period 2: Placebo (Period 1)/CJM112 High Dose (Period 2), Period 2: Placebo (Period 1)/CJM112 Low Dose (Period 2)
Placebo	Drug	Period 1: Placebo, Period 2: CJM112 High Dose (Period 1) / Placebo (Period 2)

Primary outcome

Clinical Responder Rate at Period 1: Week 16
Time frame: 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.

5 secondary outcomes

Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12
Time frame: Week 2, 4, 8 and 12
Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2
Time frame: Week 16 and Week 44
Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study
Time frame: 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
Time frame: 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
Time frame: Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211)

Results and safety

Results posted to the registry on 23 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Period 1: CJM112 High Dose	33	29
Period 1: Placebo	33	31
Extension Period 2: CJM112 High Dose /Placebo	0	0
Extension Period 2: Placebo/CJM112 Low Dose	0	0
Extension Period 2: Placebo/CJM112 High Dose	0	0

Primary outcome: Clinical Responder Rate at Period 1: Week 16

Time frame: Week 16. Number. Unit: participants

Measure	Period 1: CJM112 High Dose n = 31	Period 1: Placebo n = 32
Value	10	4

Period 1: CJM112 High Dose vs Period 1: Placebo: Posterior probablility: 0.9729

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 1: CJM112 High Dose	0 of 33 (0%)	25 of 33 (75.8%)	Not reported
Period 1: Placebo	1 of 33 (3%)	23 of 33 (69.7%)	Not reported
Extension Period 2: CJM112 High Dose /Placebo	1 of 29 (3.4%)	20 of 29 (69%)	Not reported
Extension Period 2: Placebo/CJM112 Low Dose	0 of 16 (0%)	13 of 16 (81.3%)	Not reported
Extension Period 2: Placebo/CJM112 High Dose	0 of 15 (0%)	14 of 15 (93.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. 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

Related trials for Hidradenitis Suppurativa (Acne Inversa)

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

R Hunger principal investigator

University of Bern, Switzerland

Lars French principal investigator

Zurich University Hospital, Switzerland

E P Prens principal investigator

Erasmus MC, Rotterdam, Netherlands

16 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CJM112 in people with Hidradenitis Suppurativa (Acne Inversa), run by Novartis Pharmaceuticals at 16 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Germany, Netherlands, Switzerland, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Responder Rate at Period 1: Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02421172.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.