Acne VulgarisPhase 2NCT02998671
Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne
A Phase 2 study testing CJM112 in people with Acne Vulgaris, run by Novartis Pharmaceuticals at 10 sites in 3 countries.
Trial summary
The study was designed primarily to assess preliminary efficacy and safety of CJM112 in patients with moderate to severe inflammatory acne and to determine if CJM112 has an adequate clinical profile for further clinical development. In addition, sustainability of response and dose relationship were to be explored. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- CJM112
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 22 Dec 2016to 1 Aug 2018
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects aged 18 to 45 years of age included, and otherwise in good health as determined by medical history, physical examination, vital signs, ECGs and laboratory tests at screening.
- Body weight between 50 and 120 kg, inclusive at screening.
- Patients with papulo-pustular acne vulgaris with between 25 and 100 facial inflammatory lesions (papules, pustules and nodules), and presence of non-inflammatory lesions (open and closed comedones) in the face at screening and baseline, who have failed systemic therapy for inflammatory acne.
- No more than 5 facial inflammatory nodules at screening and baseline.
- Investigator's Global assessment (IGA) score of at least moderate (3) acne severity on the face at screening and baseline.
Who cannot join
- Appropriate wash out periods are required for investigational drugs, any oral/systemic treatment for acne, systemic or lesional injected (for acne) corticosteroids or systemic immunomodulators, any systemic hormonal treatments, previous treatment with biologics, oral retinoids (in particular isotretinoin) and any topical anti-acne treatment.
- Use of facial medium depth chemical peels (excluding home regimens) within 3 months prior to baseline.
- Any live vaccines (this includes nasal-spray flu vaccine) starting from 6 weeks before baseline.
- Any other forms of acne
- Any severe, progressive or uncontrolled medical or psychiatric condition or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study.
- History of hypersensitivity or allergy to the investigational compound/compound class being used in this study.
Show all 15Show fewer
- Active systemic infections (other than common cold) during the 2 weeks prior to baseline.
- History of severe systemic Candida infections or evidence of Candidiasis in the 2 weeks prior to baseline.
- Evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB (Tuberculosis) Gold In-Tube). Patients with evidence of tuberculosis may enter the trial afteradequate treatment has been started according to local regulations.
- Patients with known active Crohn's disease
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result at screening.
- A positive Hepatitis B surface antigen or Hepatitis C test result at screening
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human chorionic gonadotropin (HCG) laboratory test.
- WOCBP, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 13 weeks after stopping medication.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Germany4 sites
Novartis Investigative Site
Bonn, 53111
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Pommelsbrunn, 91224
United States3 sites
Novartis Investigative Site
Austin, Texas, 78759
Novartis Investigative Site
Culver City, California, 90230
Novartis Investigative Site
Sacramento, California, 95819
Netherlands3 sites
Novartis Investigative Site
Bergen op Zoom, 4624 VT
Novartis Investigative Site
Groningen, 9713 GZ
Novartis Investigative Site
Leiden, 2333 CL
About this study
Official title: A Randomized, Subject and Investigator Blinded, Placebo-controlled, Multi-center Study in Parallel Groups to Assess the Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne
The study was designed primarily to assess preliminary efficacy and safety of CJM112 in patients with moderate to severe inflammatory acne and to determine if CJM112 has an adequate clinical profile for further clinical development. In addition, sustainability of response and dose relationship were to be explored.
- Conditions
- Acne Vulgaris
- Being tested
- CJM112, Placebo
- Keywords
- Acne, inflammatory acne, efficacy, safety, PK
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJM112Biological
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1: CJM112 high dose | Experimental | CJM112 high dose in treatment period 1; CJM112 high dose in extension period 2 Receives: Biological: CJM112 |
| Group 2: CJM112 low dose | Experimental | CJM112 low dose in treatment period 1; CJM112 low dose in extension period 2 Receives: Biological: CJM112 |
| Group 3: Placebo, CJM112 low dose or high dose | Placebo comparator | Placebo in treatment period 1; CJM112 low dose or CJM112 high dose in extension period 2 Receives: Biological: CJM112; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Inflammatory Facial Lesion Count at Day 85
Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85
Measured: Day 85
Secondary outcomes (7)
Number and Severity of Adverse Events in Period 1
Frequency and severity of adverse events in Period 1
Measured: Day 1 to Day 85
Number and Severity of Adverse Events in Period 2
Frequency and severity of adverse events in Period 2
Measured: Day 86 to Day 260
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1
Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.
Measured: Day 1, Day 29, Day 57 and Day 85
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2
Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.
Measured: Day 85, Day 113, Day 141 and Day 169
Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters
Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
Measured: 38 Weeks
Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters
Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
Measured: 38 Weeks
Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters
Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
Measured: 38 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start22 Dec 2016
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
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 Acne VulgarisStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998671
- Sponsor's protocol ID
- CCJM112X2203
- Status last verified
- Jun 2022
- First submitted
- 13 Dec 2016
- Last updated
- 12 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Subject and Investigator Blinded, Placebo-controlled, Multi-center Study in Parallel Groups to Assess the Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne
- ClinicalTrials.gov ID
- NCT02998671
- Acronym / sponsor ID
- CCJM112X2203
- Conditions
- Acne Vulgaris
- Keywords
- Acne, inflammatory acne, efficacy, safety, PK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Posted 10 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was designed primarily to assess preliminary efficacy and safety of CJM112 in patients with moderate to severe inflammatory acne and to determine if CJM112 has an adequate clinical profile for further clinical development. In addition, sustainability of response and dose relationship were to be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: CJM112 high dose | Experimental | Biological: CJM112CJM112 high dose in treatment period 1; CJM112 high dose in extension period 2 |
| Group 2: CJM112 low dose | Experimental | Biological: CJM112CJM112 low dose in treatment period 1; CJM112 low dose in extension period 2 |
| Group 3: Placebo, CJM112 low dose or high dose | Placebo comparator | Biological: CJM112, Other: PlaceboPlacebo in treatment period 1; CJM112 low dose or CJM112 high dose in extension period 2 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female subjects aged 18 to 45 years of age included, and otherwise in good health as determined by medical history, physical examination, vital signs, ECGs and laboratory tests at screening.
- Body weight between 50 and 120 kg, inclusive at screening.
- Patients with papulo-pustular acne vulgaris with between 25 and 100 facial inflammatory lesions (papules, pustules and nodules), and presence of non-inflammatory lesions (open and closed comedones) in the face at screening and baseline, who have failed systemic therapy for inflammatory acne.
- No more than 5 facial inflammatory nodules at screening and baseline.
- Investigator's Global assessment (IGA) score of at least moderate (3) acne severity on the face at screening and baseline.
Key exclusion criteria (15 listed)
- Appropriate wash out periods are required for investigational drugs, any oral/systemic treatment for acne, systemic or lesional injected (for acne) corticosteroids or systemic immunomodulators, any systemic hormonal treatments, previous treatment with biologics, oral retinoids (in particular isotretinoin) and any topical anti-acne treatment.
- Use of facial medium depth chemical peels (excluding home regimens) within 3 months prior to baseline.
- Any live vaccines (this includes nasal-spray flu vaccine) starting from 6 weeks before baseline.
- Any other forms of acne
- Any severe, progressive or uncontrolled medical or psychiatric condition or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study.
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 |
|---|---|---|
| CJM112 | Biological | Group 1: CJM112 high dose, Group 2: CJM112 low dose, Group 3: Placebo, CJM112 low dose or high dose |
| Placebo | Other | Group 3: Placebo, CJM112 low dose or high dose |
Primary outcome
Total Inflammatory Facial Lesion Count at Day 85
Time frame: Day 85
Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85
7 secondary outcomes
Number and Severity of Adverse Events in Period 1
Time frame: Day 1 to Day 85
Number and Severity of Adverse Events in Period 2
Time frame: Day 86 to Day 260
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1
Time frame: Day 1, Day 29, Day 57 and Day 85
Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2
Time frame: Day 85, Day 113, Day 141 and Day 169
Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters
Time frame: 38 Weeks
Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters
Time frame: 38 Weeks
Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters
Time frame: 38 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 3 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 Acne Vulgaris, run by Novartis Pharmaceuticals at 10 sites in 3 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 5 inclusion and 15 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 12 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 10 sites in Germany, United States, Netherlands. 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 10 Oct 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?
Total Inflammatory Facial Lesion Count at Day 85 (time frame: Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2022.