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

This study is designed as a proof of concept (PoC) study of CJM112 in
hidradenitis suppurativa (HS). The purpose of the study is to assess the
clinical efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics
of CJM112, and to explore the dose-effect relationship of CJM112 in moderate to
severe chronic HS patients.

1. To determine the efficacy of CJM112 300 mg in chronic hidradenitis
suppurativa (HS) patients, by clinical responder rate at week 16.
2. To assess the safety and tolerability of CJM112 in patients with chronic
hidradenitis suppurativa (HS)
3. To assess the efficacy of CJM112 in chronic HS patients, by clinical
responder rate at time points other than week 16
4. To evaluate the pharmacokinetics and pharmacodynamics (including target
capture) of CJM112 in HS patients after multiple s.c. administration
5. To assess immunogenicity (IG)

This is a randomized, placebo controlled, double blind, multicenter,
nonconfirmatory, study in patients with moderate to severe chronic HS in
parallel groups. Study consists of approximately 4 weeks screening period, two
sequential treatment periods of 16 weeks (period 1 and extension period 2) and
approximately 12 weeks follow up. Patients are randomized in a 2:1:1 ratio to
one of the following three treatment sequences:

Treatment sequence 1: CJM112 300 mg s.c. in period 1; placebo s.c. in extension
period 2 (n=30)
Treatment sequence 2: Placebo s.c. in period 1; CJM112 50 mg s.c. in extension
period 2 (n=15)
Treatment sequence 3: Placebo s.c. in period 1; CJM112 300 mg s.c. in extension
period 2 (n=15)

During each treatment period patients will be dosed a total of 10 times. Study
medication will be administered subcutaneously (s.c.) at clinical center. The
first five doses will be administrated weekly, followed by five bi-weekly
administrations. The chosen primary endpoint is the clinical response rate
(based on responders defined as a 2 point reduction in HS-PGA score from
baseline).

Treatment sequence 1:
Period 1 (16 weeks): CJM112, 300 mg s.c.
Extension period 2 (16 weeks): Placebo s.c.

Treatment sequence 2:
Period 1 (16 weeks): Placebo s.c.
Extension period 2 (16 weeks): CJM112, 50 mg s.c.

Treatment sequence 3:
Period 1 (16 weeks): Placebo s.c.
Extension period 2 (16 weeks): CJM112, 300 mg s.c.

Burden:
Studie duration approx 11 months. approx 24 visits. 3-4 hr per visit
Physical Examination (skin inclusive): 17 times
Blood collection / analysis: 16 visits (44 x blood collection, 3-33 ml per
collection)
Urine collection / analysis: 16 times
ECG: 16 times
Skin Tape strips: 12 times
Ultrasound: 5 times
Completion of questionnaiers(6): 2 times (symptoms) till 15 times (pain). The
other questionnaires: 10x, 13x, 13x, 14x.
Subcutaneous injections: 10 times (twice).
Optional:
Farmacogenetic/-genomic blood analysis (6 ml): 1 time
Digital photography Skin: 5 times
Skin Biopsy: 5 times

Prohibited concomitant medications and possible postponement of surgery with
wide excision of the affected tissue.

Risk:
CJM112 is still in the development phase. There are about 30 patients treated
with CJM112. Therefore, not all the possible side effects are known. We know of
other drugs that resemble CJM112 and which already more is known that can cause
this type of drug side effects listed below:
* Increased risk of infection. The most common infections are not serious
respiratory infections of the mouth, nose and throat.
* More likely to diarrhea, runny nose and red, irritated eyes.

* Blood tests: Fainting, pain and / or a bruise. Rarely creates a scab or
infection at the puncture site.
* The s.c. injections with IMP: Can do some pain. The puncture site can be
somewhat red or blue and may be itchy.
* The skin tests: The adhesive strips can cause some discomfort. They rarely
cause damage, such as a small hemorrhage.