{
  "topic": {
    "stem": "AVACOPAN_ANCA_REVIEW",
    "name": "Avacopan in ANCA-associated vasculitis",
    "ncts": [
      "NCT02994927",
      "NCT02222155"
    ],
    "drug_patterns": [
      "avacopan"
    ],
    "condition_patterns": [
      "anca",
      "vasculitis",
      "granulomatosis"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT02994927",
        "aact_title": "A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis",
        "aact_acronym": "ADVOCATE",
        "start_date": "2017-03-15",
        "primary_completion_date": "2019-09-07",
        "aact_intvs": [
          "Avacopan",
          "Prednisone",
          "Cyclophosphamide",
          "Rituximab",
          "Azathioprine"
        ],
        "aact_conditions": [
          "anca-associated vasculitis"
        ],
        "pmid": "41052893",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1136/rmdopen-2025-005743",
        "aact_per_arm_counts": {
          "BG000": 164,
          "BG001": 166
        },
        "aact_primary_outcome_measure": "Percentage of Subjects Achieving Disease Remission at Week 26",
        "aact_outcome_count_rows": [
          [
            "OG001",
            "27.0"
          ],
          [
            "OG000",
            "21.0"
          ],
          [
            "OG001",
            "6.0"
          ],
          [
            "OG000",
            "124.0"
          ],
          [
            "OG001",
            "113.0"
          ],
          [
            "OG000",
            "25.0"
          ],
          [
            "OG001",
            "31.0"
          ],
          [
            "OG000",
            "70.1"
          ],
          [
            "OG001",
            "72.3"
          ],
          [
            "OG000",
            "54.9"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": false,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT02222155",
        "aact_title": "Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis",
        "aact_acronym": "",
        "start_date": "2015-02-04",
        "primary_completion_date": "2016-04-24",
        "aact_intvs": [
          "CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids",
          "CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids",
          "Placebo, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids"
        ],
        "aact_conditions": [
          "anca-associated vasculitis"
        ],
        "pmid": "33128347",
        "pubmed_year": 2020,
        "pubmed_doi": "10.1002/acr2.11185",
        "aact_per_arm_counts": {
          "BG000": 13,
          "BG001": 13,
          "BG002": 16
        },
        "aact_primary_outcome_measure": "Incidence of Adverse Events",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "13.0"
          ],
          [
            "OG001",
            "11.0"
          ],
          [
            "OG002",
            "15.0"
          ],
          [
            "OG000",
            "0.85"
          ],
          [
            "OG001",
            "0.92"
          ],
          [
            "OG002",
            "0.8"
          ],
          [
            "OG000",
            "0.54"
          ],
          [
            "OG001",
            "0.67"
          ],
          [
            "OG002",
            "0.47"
          ],
          [
            "OG000",
            "0.15"
          ]
        ]
      }
    }
  ],
  "gate_summary": {
    "A_aact_exists": 2,
    "B_drug_in_intvs": 1,
    "C_condition_in_aact": 2,
    "D_pmid_topic_match": 2,
    "E_two_arms": 2,
    "F_primary_outcome_known": 2
  },
  "n_total": 2,
  "n_pass_all": 1,
  "pass_rate": 0.5,
  "verdict": "VIABLE"
}