Title

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

    Phase 2
  • Study Type

    Interventional
  • Intervention/Treatment

    cjm112 ...
  • Study Participants

    66
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.
Study Started
Apr 13
2015
Primary Completion
Nov 23
2016
Study Completion
Nov 23
2016
Results Posted
May 23
2019
Last Update
Jul 13
2022

Biological CJM112

CJM112 Fully human IgG1 monoclonal antibody

Drug Placebo

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

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

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

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

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

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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
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

Summary

Period 1: CJM112 High Dose

Period 1: Placebo

Extension Period 2: CJM112 High Dose /Placebo

Extension Period 2: Placebo/CJM112 Low Dose

Extension Period 2: Placebo/CJM112 High Dose

All Events

Event Type Organ System Event Term Period 1: CJM112 High Dose Period 1: Placebo Extension Period 2: CJM112 High Dose /Placebo Extension Period 2: Placebo/CJM112 Low Dose Extension Period 2: Placebo/CJM112 High Dose

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.

Period 1: CJM112 High Dose

10.0
participants

Period 1: Placebo

4.0
participants

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.

Period 1: CJM112 High Dose

Week 12

7.0
count of participants

Week 2

4.0
count of participants

Week 4

6.0
count of participants

Week 8

5.0
count of participants

Period 1: Placebo

Week 12

4.0
count of participants

Week 2

3.0
count of participants

Week 4

3.0
count of participants

Week 8

6.0
count of participants

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)

Period 1: CJM112 High Dose

21.4
ug/mL (Mean)
Standard Deviation: 11.6

Extension Period 2: Placebo/CJM112 Low Dose

3.1
ug/mL (Mean)
Standard Deviation: 2.6

Extension Period 2: Placebo/CJM112 High Dose

24.4
ug/mL (Mean)
Standard Deviation: 19.0

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)

Period 1: CJM112 High Dose

16.09
days (Mean)
Standard Deviation: 3.500

Extension Period 2: Placebo/CJM112 Low Dose

22.81
days (Mean)
Standard Deviation: 0

Extension Period 2: Placebo/CJM112 High Dose

19.85
days (Mean)
Standard Deviation: 3.807

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)

Period 1: CJM112 High Dose

NO Pre-existing Antibodies ADA negative

21.0
participants

NO Pre-existing Antibodies ADA positive

9.0
participants

Pre-existing Antibodies ADA negative

2.0
participants

Pre-existing Antibodies ADA positive

1.0
participants

Extension Period 2: Placebo/CJM112 Low Dose

NO Pre-existing Antibodies ADA negative

10.0
participants

NO Pre-existing Antibodies ADA positive

4.0
participants

Pre-existing Antibodies ADA negative

1.0
participants

Pre-existing Antibodies ADA positive

1.0
participants

Extension Period 2: Placebo/CJM112 High Dose

NO Pre-existing Antibodies ADA negative

9.0
participants

NO Pre-existing Antibodies ADA positive

1.0
participants

Pre-existing Antibodies ADA negative

7.0
participants

Pre-existing Antibodies ADA positive

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)

Period 1: CJM112 High Dose

Post-dose

1160.0
pg/mL (Mean)
Standard Deviation: 3190

Pre-dose

361.0
pg/mL (Mean)
Standard Deviation: 2010

Extension Period 2: Placebo/CJM112 Low Dose

Post-dose

943.0
pg/mL (Mean)
Standard Deviation: 583

Pre-dose

163.0
pg/mL (Mean)
Standard Deviation: 647

Extension Period 2: Placebo/CJM112 High Dose

Post-dose

821.0
pg/mL (Mean)
Standard Deviation: 538

Pre-dose

158.0
pg/mL (Mean)
Standard Deviation: 372

Total

66
Participants

Age, Continuous

37
years (Mean)
Standard Deviation: 10.5

Sex: Female, Male

Period 1

Period 1: CJM112 High Dose

Period 1: Placebo

Period 2

Extension Period 2: CJM112 High Dose /Placebo

Extension Period 2: Placebo/CJM112 Low Dose

Extension Period 2: Placebo/CJM112 High Dose

Drop/Withdrawal Reasons

Period 1: Placebo

Period 1: CJM112 High Dose

Extension Period 2: CJM112 High Dose /Placebo

Extension Period 2: Placebo/CJM112 Low Dose

Extension Period 2: Placebo/CJM112 High Dose