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Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity
Phase 3 trial testing Humira 40 MG in Prefilled Syringe in Moderate Chronic Plaque Psoriasis in 374 participants. Completed in 19 September 2023.
| Lead sponsor | Biocon Biologics Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 374 |
| Start date | 21 November 2022 |
| Primary completion | 19 September 2023 |
| Estimated completion | 19 September 2023 |
| Sites | 36 locations across Estonia, Bulgaria, Poland, Czechia |
Biocon Biologics Inc. — full company profile →
Adults 18 to 75, any sex, with Moderate Chronic Plaque Psoriasis or Severe Chronic Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
AUCτ, 26-28 (Area under the adalimumab concentration-time curve \[AUC\] over the dosing interval of Week 26-28)
| Group | Value | 95% CI |
|---|---|---|
| Group 1 :- Humira Continuously | 2127.57 | ± 1432.80 |
| Group 2:- Repeated Switches Humira - Hulio | 2357.61 | ± 1636.09 |
Cmax, 26-28 (Maximum observed adalimumab concentration during the dosing interval Week 26-28).
| Group | Value | 95% CI |
|---|---|---|
| Group 1 Humira Continuously | 7.69 | ± 4.96 |
| Group 2 :- Repeated Switches Humira - Hulio | 8.46 | ± 5.42 |
Time frame: 16 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group 1:- Humira Continuou… | Group 2:- Repeated Switche… |
|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | — | — |
| Vestibular neuronitis | Infections and infestations | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — |
| Multiple fractures | Injury, poisoning and procedural complications | — | — |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | — | — |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Deep vein thrombosis | Vascular disorders | — | — |
| Reaction | System | Group 1:- Humira Continuou… | Group 2:- Repeated Switche… |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — |
| Headache | Nervous system disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Pharyngitis | Infections and infestations | — | — |
| Injection site pain | General disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Rhinitis | Infections and infestations | — | — |
| Injection site erythema | General disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | — | — |
| Psoriasis | Skin and subcutaneous tissue disorders | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Tonsillitis | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Influenza | Infections and infestations | — | — |
| Sinusitis | Infections and infestations | — | — |
| Injection site pruritus | General disorders | — | — |
| Injection site swelling | General disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Oral herpes | Infections and infestations | — | — |
| Pulpitis dental | Infections and infestations | — | — |
| Bacteriuria | Infections and infestations | — | — |
| Bronchitis | Infections and infestations | — | — |
| COVID-19 | Infections and infestations | — | — |
| COVID-19 pneumonia | Infections and infestations | — | — |
| Folliculitis | Infections and infestations | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Gastrointestinal infection | Infections and infestations | — | — |
| Gastrointestinal viral infection | Infections and infestations | — | — |
| Helicobacter infection | Infections and infestations | — | — |
| Lyme disease | Infections and infestations | — | — |
| Oral candidiasis | Infections and infestations | — | — |
| Pharyngitis streptococcal | Infections and infestations | — | — |
| Pseudomonas infection | Infections and infestations | — | — |
| Skin candida | Infections and infestations | — | — |
| Varicella zoster virus infection | Infections and infestations | — | — |
| Vestibular neuronitis | Infections and infestations | — | — |
Most-reported serious reactions: COVID-19 pneumonia, Vestibular neuronitis, Acute myocardial infarction, Multiple fractures, Intervertebral disc protrusion, Basal cell carcinoma, Deep vein thrombosis.
Data from ClinicalTrials.gov NCT05637515 adverse events section.
Hulio is a monoclonal antibody currently approved as a biosimilar to European Union approved and United States (US)-Licensed Humira. This is a multicenter, randomized blinded, parallel group, interchangeability study in subjects with moderate to severe chronic plaque psoriasis, undergoing repeated switches between Humira and Hulio. The study is designed to confirm the pharmacokinetic equivalence of alternating between the use of Humira and Hulio and, Humira without such alternation or switch, in accordance with the US Food and Drug Administration Guidance for Industry, Considerations in Demonstrating Interchangeability with a Reference Product. The study will also assess safety, efficacy and immunogenicity between these two groups.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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