Phase 3
Completed N=572
Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT02581345 ↗Enrolled (actual)
572
Serious AEs
3.5%
Results posted
Sep 2018
Primary outcomePrimary: Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16 — 80.1; 79.0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (M923) and Humira in participants with moderate to severe chronic plaque-type psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16 |
80.1; 79.0 | — |
| SECONDARY Percentage of Participants With a Response of Clear or Almost Clear on the Static Physician Global Assessment (sPGA) at Week 16 |
68.9; 66.1 | — |
| SECONDARY Number of Participants Achieving PASI 50 Response at Week 16 |
243; 253 | — |
| SECONDARY Number of Participants Achieving PASI 50 Response at Week 52 (Follow-Up Visit) |
228; 111; 113 | — |
| SECONDARY Number of Participants Achieving PASI 75 Response at Week 52 (Follow-Up Visit) |
202; 96; 101 | — |
| SECONDARY Number of Participants Achieving PASI 90 Response at Week 16 |
165; 147 | — |
| SECONDARY Number of Participants Achieving PASI 90 Response at Week 52 (Follow-Up Visit) |
159; 71; 77 | — |
| SECONDARY Absolute PASI Score at Baseline |
21.34; 20.29 | — |
| SECONDARY Absolute PASI Score at Week 16 |
2.58; 2.50 | — |
| SECONDARY Absolute PASI Score at Week 52 (Follow-Up Visit) |
2.76; 2.85; 2.67 | — |
| SECONDARY Percent Change From Baseline in PASI Score at Week 16 |
-86.21; -86.79 | — |
| SECONDARY Percent Change From Baseline in PASI Score at Week 52 (Follow-Up Visit) |
-86.43; -85.53; -85.64 | — |
| SECONDARY Health-Related Quality of Life During Treatment: Dermatology Life Quality Index (DLQI) Score at Baseline |
12.5; 10.5 | — |
| SECONDARY Health-Related Quality of Life During Treatment: DLQI Score at Week 16 |
2.4; 2.1 | — |
| SECONDARY Health-Related Quality of Life During Treatment: DLQI Score at Week 48 (Completion/Termination Visit) |
2.1; 1.6; 2.1 | — |
| SECONDARY Health-Related Quality of Life During Treatment: EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L) at Baseline |
71.3; 72.5 | — |
| SECONDARY Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 16 |
83.7; 83.4 | — |
| SECONDARY Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 48 (Completion/Termination Visit) |
85.3; 83.9; 84.2 | — |
| SECONDARY Number of Participants With Clinically Meaningful Changes in Vital Signs |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 |
1; 1; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) |
1; 0; 1; 1; 0; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Baseline |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 16 |
2; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 48 (Completion/Termination Visit) |
3; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
169; 194; 199; 99; 103 | — |
| SECONDARY Pharmacokinetics: Serum Concentrations by Treatment |
302; 301; 9100; 7640; 8580; 6990 | — |
| SECONDARY Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at Baseline |
15; 11; 1; 2; 16; 13 | — |
| SECONDARY Immunogenicity: Number of Participants With ADA at Week 16 |
135; 144; 4; 8; 139; 152 | — |
| SECONDARY Immunogenicity: Number of Participants With ADA at Week 25 |
144; 80; 92; 12; 5; 5 | — |
| SECONDARY Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit) |
131; 73; 80; 10; 6; 7 | — |
| SECONDARY Immunogenicity: Number of Participants With ADA and nADA by Titer at Baseline |
266; 271; 16; 13 | — |
| SECONDARY Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16 |
16; 26; 2; 2; 90; 73 | — |
| SECONDARY Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25 |
24; 19; 21; 6; 2; 4 | — |
| SECONDARY Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit) |
26; 11; 17; 0; 2; 3 | — |
| SECONDARY Median Time to Seroconversion |
113.0; 113.0; 112.0 | — |
Eligibility Criteria
Inclusion Criteria
- Must be able to understand and communicate with the investigator and comply with the requirements of the study
- Chronic plaque-type psoriasis diagnosed for at least 6 months before screening
- Stable plaque psoriasis
- History of receipt of or candidate for therapy.
- Moderate to severe psoriasis at screening and baseline
- Must be willing and able to self-administer SC injections or have a caregiver available to administer injections
- Male participants of childbearing potential must employ a highly effective contraceptive measure
- Female participants must have a negative pregnancy test; are not planning to become pregnant; and must not be lactating. Female participants must also agree to employ a highly effective contraceptive measure.
Exclusion Criteria
- Forms of psoriasis other than chronic plaque-type
- Drug-induced psoriasis.
- Other skin conditions which would interfere with assessment of psoriasis
- Medical conditions other than psoriasis for which systemic corticosteroids were used in the last year prior to screening
- Other inflammatory conditions other than psoriasis or psoriatic arthritis
- Prior use of systemic tumor necrosis factor (TNF) inhibitors, or 2 or more non-TNF biologic therapies
- Ongoing use of prohibited psoriasis treatments
- Ongoing use of other non-psoriasis prohibited treatments
- All other prior non-psoriasis concomitant treatments must be on a stable dose for at least 4 weeks
- Laboratory abnormalities at screening deemed clinically significant by the investigator
- Any condition or illness which in the opinion of the investigator or sponsor poses an unacceptable safety risk
- History of latex allergy
- History of or current signs or symptoms or diagnosis of a demyelinating disorder
- History of or current Class III or IV New York Heart Association congestive heart failure
- Signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
- Current malignancy or history of any malignancy except adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ; no more than 3 lifetime basal cell and squamous cell carcinomas permitted
- Chronic infections, recurrent infections; recent infection to be evaluated
- History of or presence of human immunodeficiency virus (HIV), or Hepatitis B (HBV) or C virus (HCV)
- History of active tuberculosis (TB) or untreated or inadequately treated latent TB.
- Exposure to an investigational product ≤30 days prior to enrollment or participation in another clinical study during the course of this study
- Participant is a family member or employee of the investigator or site staff or study team
Data sourced from ClinicalTrials.gov (NCT02581345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.