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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO7160ASH1001 | Other Identifier | Janssen Research & Development LLC. | |
| 2014-000633-23 | EudraCT Number |
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The purpose of this study is to evaluate the safety and tolerability of single ascending dose of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose administered IV in participants with asthma and atopic dermatitis.
This is a Phase 1, randomized, placebo-controlled, multicenter study of CNTO 7160. The study consists of Screening Period, In-patient period (6 days for healthy participants, 11 days for asthmatic participants and atopic dermatitis participants) and outpatient period (105 days for healthy participants, 110 days for asthmatic and atopic dermatitis participants). The total duration of participation for each participant will be approximately 21 weeks for healthy participants, 25 weeks for asthmatic participants, and atopic dermatitis participants. All eligible participants will be randomly assigned to receive active agent or placebo. The study will be conducted in 2 parts. In Part 1, single ascending doses of CNTO 7160 or placebo will be administered to sequential cohorts of healthy participants as an IV infusion. In Part 2, ascending multiple doses of CNTO 7160 or placebo will be administered as IV infusions to sequential cohorts of participants with asthma or atopic dermatitis. Blood samples will be collected for assessment of pharmacokinetic and pharmacodynamics parameters in both part 1 and 2 parameters, along with assessment of safety and clinical effects in part 2. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose 1 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 1. |
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| Part 1: Dose 2 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 2. |
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| Part 1: Dose 3 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 3. |
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| Part 1: Dose 4 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 4. |
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| Part 1: Dose 5 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 5. |
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| Part 1: Dose 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part 1: CNTO 7160 | Drug | Participants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg). |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 1) | The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group. | Through Week 17 |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 2) | The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group. | Through Week 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) (Part 1) | Cmax (microgram per millileter [mcg/mL]) will be summarized by treatment group. | Up to Week 17 after dose |
| Maximum Observed Serum Concentration (Cmax) (Part 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32415720 | Result | Nnane I, Frederick B, Yao Z, Raible D, Shu C, Badorrek P, van den Boer M, Branigan P, Duffy K, Baribaud F, Fink D, Yang TY, Xu Z. The first-in-human study of CNTO 7160, an anti-interleukin-33 receptor monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis. Br J Clin Pharmacol. 2020 Dec;86(12):2507-2518. doi: 10.1111/bcp.14361. Epub 2020 Jun 14. |
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Drug CNTO7160 or Placebo administered IV infusion Dose 6. |
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| Part 1: Dose 7 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 7. |
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| Part 1: Dose 8 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 8. |
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| Part 1: Dose 9 | Experimental | Drug CNTO7160 or Placebo administered IV infusion Dose 9. |
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| Part 2 (Asthma): Dose 1 | Experimental | Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks). |
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| Part 2 (Asthma): Dose 2 | Experimental | Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks). |
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| Part 2 (Atopic Dermatitis): Dose 1 | Experimental | Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks). |
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| Part 2 (Atopic Dermatitis): Dose 2 | Experimental | Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks). |
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| Part 2 (Asthma): CNTO 7160 | Drug | Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks). |
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| Part 2 (Atopic Dermatitis): CNTO 7160 | Drug | Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks). |
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| Part 1 and Part 2: Placebo | Drug | Participants will receive single IV infusion of placebo matched to CNTO 7160. |
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Cmax (mcg/mL) after the first and last dose will be summarized by treatment group.
| Up to Week 21 after dose |
| Area Under the Serum Time Curve [AUC(0-t) and AUC(0-infinity)] (Part 1) | AUC (mcg*day/mL) will be summarized by treatment group. | Up to Week 17 after dose |
| Area Under the Serum Concentration Versus Time Curve [AUC(t1-t2)] (Part 2) | AUC (mcg*day/mL) will be summarized by treatment group. | Up to Week 21 after dose |
| Number of Participants With Antibodies to CNTO 7160 (Part 1) | The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group. | Up to Week 17 |
| Number of Participants with Antibodies to CNTO 7160 (Part 2) | The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group. | Up to Week 21 |
| Change From Baseline in Immunoglobulin E (IgE) (Part 2) | Change from Baseline in immunoglobulin E (IgE) Concentration (international unit per millileter [IU/mL]) through Week 21 will be summarized by treatment group. | Baseline, Week 21 |
| Change from Baseline in Chemokine (C-C motif) Ligand 17 (CCL17) (Part 2) | Change from Baseline in Chemokine (C-C motif) Ligand 17 (CCL17) concentration (picogram per millileter [pg/mL]) through Week 21 will be summarized by treatment group. | Baseline, Week 21 |
| Change From Baseline in Forced Expiratory Volume in 1 second (FEV1) in Participants With Asthma | Changes in FEV1 (liter [L]) from baseline through end of follow up will be summarized by treatment group. | Baseline Up to week 21 |
| Change From Baseline in Eczema Area Severity Index (EASI) in Participants With Atopic Dermatitis | Changes in EASI score from baseline through the end of follow up will be summarized by treatment group. | Baseline up to week 21 |
| Merksem |
| Belgium |
| Berlin | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Kiel | Germany |
| Mönchengladbach | Germany |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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