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Completed

NCT Number: NCT02421172

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Roskilde, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CJM112

Biological

CJM112 Fully human IgG1 monoclonal antibody

Placebo

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12

    Time frame: 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.

  2. Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2

    Time frame: 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)

  3. 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)

    T1/2 The terminal elimination half-life for Period 1 (Week 16) and Period 2/End of Study (Week 44)

  4. 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)

    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)

  5. 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)

    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)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2015
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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