E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic hidradenitis suppurativa |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020041 |
E.1.2 | Term | Hidradenitis suppurativa |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the efficacy of CJM112 in chronic hidradenitis suppurativa (HS) patients by clinical responder rate at week 16 |
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E.2.2 | Secondary objectives of the trial |
- To assess the safety and tolerability of CJM112 in patients with chronic hidradenitis suppurativa (HS)
- To assess the efficacy of CJM112 in chronic HS patients, by clinical responder rate at time points other than week 16
- To evaluate the pharmacokinetics and pharmacodynamics (including target capture) of CJM112 in HS patients after multiple s.c. administration
- To assess immunogenicity (IG) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 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
2. Weight between 50 kg and 150 kg
3. HS-PGA score of at least moderate severity at the time of inclusion with at least 4 inflammatory 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)
See prototocl for other criteria and details. |
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E.4 | Principal exclusion criteria |
1. Use of previous biologics or other specified concomitant medications
2. Use of any systemic treatment for HS in the last 4 weeks prior to randomization
3. Presence of more than 25 draining fistulae at baseline.
4. Surgical treatment for HS in the last 4 weeks prior to randomization/first treatment.
5. Women of childbearing potential and sexually active males unwilling to use a condom during intercourse while taking drug and for 15 weeks after stopping investigational medication.
6. Evidence of active tuberculosis at screening
7. History of severe systemic Candida infections or evidence of Candidiasis in the last two weeks
8. Active systemic or skin infections (other than common cold or HS related) during the two weeks before randomization/first treatment
9. Any live vaccines (including nasal spray flu vaccine) starting from 6 weeks before randomization.
See prototocl for other criteria and details. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa
- Physician Global Assessment (HS-PGA) score |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Frequency of adverse events, safety laboratories, physical exam, vital signs, ECG
- Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score
- Anti-CJM112 antibodies in serum |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to the end of the study |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Denmark |
Germany |
Netherlands |
Switzerland |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |