Trial · NCT02808429
Efficacy and Safety of Atacicept in IgA Nephropathy
NCT02808429, Phase 2, Terminated, EMD Serono Research & Development Institute, Inc.; results first posted 2021-02-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Atacicept in IgA Nephropathy. Trials, record NCT02808429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02808429
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Atacicept in IgA Nephropathy
- NCT number
- NCT02808429
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- IgA Nephropathy
- Interventions
- Placebo, Atacicept 25 mg, Atacicept 75 mg
- First posted
- 2016-06-21
- Last updated
- 2021-02-25
- Other registries' IDs
- eudract:2016-002262-31
- Results first posted
- 2021-02-25
- Limitations and caveats
- The study was prematurely terminated due to poor enrollment and Part B was not conducted as per Sponsor decision. This decision was not related to any safety or efficacy findings regarding Atacicept.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Baseline up to 96 weeks | Adverse Event (AE): any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: AEs that developed or worsened/became serious during on-treatment period (time from the first dose of study drug up to the end of study \[Week 96\]). TEAEs included serious AEs and non- serous AEs. AESIs included infections, cardiac failure, cardiomyopathy/ ischemic heart disease, hypersensitivity reaction (including anaphylactic/anaphylactoid shock conditions, asthma/bronchospasm, and angioedema), injection site reactions (ISRs) and demyelinating disorders. Investigator or his /her designee assessed ISRs as local reactions (redness, bruising, swelling, induration and itching). |
| Secondary | Serum Atacicept Concentrations | Week 0 Day 1 (pre-dose), Weeks 1, 2, 4, 8, 12, 16, 24, 40, 48, 72, Early Termination (up to Week 72) and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24 | Serum Atacicept Concentrations was to be performed; however; as per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed. |
| Secondary | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24 | The change in serum levels of IgA from baseline was reported. |
| Secondary | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24 | The change in serum levels of IgG from baseline was reported. |
| Secondary | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and at PT FU Weeks 4, 12 and 24 | The change in serum levels of IgM from baseline was reported. |
| Secondary | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72 and at PT FU Weeks 12 and 24 | The change in serum Gd-IgA1 from baseline was reported. |
| Secondary | Change From Baseline in Serum Complement C3 and C4 Levels | Baseline, Week 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Weeks 12 and 24 | The change in serum component C3 and C4 from baseline were reported. |
| Secondary | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Week 24 | Change from baseline in immune cell subsets included total T cells, helper T cells, cytotoxic T cells, total B cells (assay with \[AW\] CD45 or assay without \[AWO\] CD45), mature naïve B cells, memory B cells, plasma cells, plasma blasts, and natural killer (NK) cells and were reported. Analysis was performed by flow cytometry analysis. |
| Secondary | Change From Baseline in Urinary IgG, IgA, and IgM Levels | Baseline (Day1), Weeks 24, 48 and Early Termination (up to earlier than Week 72) | Urinary IgG, IgA and IgM levels to be measured by Immuno-Electrophoresis. |
| Secondary | Percentage of Participants With Positive Anti-Drug Antibody (ADA) | Baseline up to safety follow-up (96 weeks) | Percentage of participants with positive ADA were reported. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Baseline up to 96 weeks | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. | percentage of participants | NUMBER |
| SECONDARY | Serum Atacicept Concentrations | Week 0 Day 1 (pre-dose), Weeks 1, 2, 4, 8, 12, 16, 24, 40, 48, 72, Early Termination (up to Week 72) and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24 | As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed. | ||
| SECONDARY | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24 | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here number analyzed = participants who were evaluable for this outcome measure at given time points. | gram per liter | MEAN |
| SECONDARY | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24 | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here number analyzed = participants who were evaluable for this outcome measure at given time points. | gram per liter | MEAN |
| SECONDARY | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and at PT FU Weeks 4, 12 and 24 | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here number analyzed = participants who were evaluable for this outcome measure at given time points. | gram per liter | MEAN |
| SECONDARY | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72 and at PT FU Weeks 12 and 24 | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here number analyzed = participants who were evaluable for this outcome measure at given time points. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Change From Baseline in Serum Complement C3 and C4 Levels | Baseline, Week 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Weeks 12 and 24 | The safety population set (SAF) consisted of all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Number of participants analyzed signifies participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable for specified category. | milligram per liter | MEAN |
| SECONDARY | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Week 24 | Flow Cytometry (FC) Set: all participants in SAF set who were part of the selected sites for FC analysis and who had at least 1 sample taken for FC analysis. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure. and number analyzed signifies those participants who were evaluable for specified category. | cells per microliter | MEAN |
| SECONDARY | Change From Baseline in Urinary IgG, IgA, and IgM Levels | Baseline (Day1), Weeks 24, 48 and Early Termination (up to earlier than Week 72) | As per changed in planned analysis the outcome measure related to Urinary Immunoglobulins was not assessed. | ||
| SECONDARY | Percentage of Participants With Positive Anti-Drug Antibody (ADA) | Baseline up to safety follow-up (96 weeks) | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group402
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Placebo | Participants with TEAE | 100 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Atacicept 25 mg | Participants with TEAE | 100 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Atacicept 75 mg | Participants with TEAE | 60 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Placebo | Participants with AESI: Cardiac failure | 0 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Atacicept 25 mg | Participants with AESI: Cardiac failure | 0 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Atacicept 75 mg | Participants with AESI: Cardiac failure | 0 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Placebo | Participants with AESI: Ischaemic heart disease | 0 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Atacicept 25 mg | Participants with AESI: Ischaemic heart disease | 0 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Atacicept 75 mg | Participants with AESI: Ischaemic heart disease | 0 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Placebo | Participants with AESI: Cardiac arrhythmia | 0 | percentage of participants |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | STARTED | Atacicept 25 mg | 6 | |
| Overall Study | STARTED | Atacicept 75 mg | 5 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | COMPLETED | Atacicept 25 mg | 5 | |
| Overall Study | COMPLETED | Atacicept 75 mg | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Atacicept 25 mg | 1 | |
| Overall Study | NOT COMPLETED | Atacicept 75 mg | 2 |
Source ClinicalTrials.gov
Adverse events183
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site erythema | General disorders | Placebo | 0 | 5 | |
| other | Injection site erythema | General disorders | Atacicept 25 mg | 4 | 6 | |
| other | Injection site erythema | General disorders | Atacicept 75 mg | 1 | 5 | |
| other | Injection site bruising | General disorders | Placebo | 0 | 5 | |
| other | Injection site bruising | General disorders | Atacicept 25 mg | 3 | 6 | |
| other | Injection site bruising | General disorders | Atacicept 75 mg | 0 | 5 | |
| other | Injection site pruritus | General disorders | Placebo | 0 | 5 | |
| other | Injection site pruritus | General disorders | Atacicept 25 mg | 3 | 6 | |
| other | Injection site pruritus | General disorders | Atacicept 75 mg | 0 | 5 | |
| other | Injection site reaction | General disorders | Placebo | 0 | 5 |
1 to 10 of 183Source ClinicalTrials.gov
See all 183 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 5 |
| Total, all-cause mortality | Atacicept 25 mg | 0 | 6 |
| Total, all-cause mortality | Atacicept 75 mg | 0 | 5 |
| Total, other adverse events | Placebo | 5 | 5 |
| Total, other adverse events | Atacicept 25 mg | 6 | 6 |
| Total, other adverse events | Atacicept 75 mg | 3 | 5 |
| Total, serious adverse events | Placebo | 1 | 5 |
| Total, serious adverse events | Atacicept 25 mg | 3 | 6 |
| Total, serious adverse events | Atacicept 75 mg | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02808429
GET https://conductscience.org/api/trials/v1/NCT02808429/results?page=2